ACCURUN eQuality™ – Peer Review Analysis

Human Plasma

SeraCare's worldwide procurement and donor database networks ensure a safe, reliable supply of human sera and plasma products, highly customizable to meet your specific requirements.

Normal Human Plasma

Processed Human Plasma (including SeraCon)

DNPLASMA

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Normal Human Serum

SeraCare Human Serum meets the highest quality standards for use as a base matrix, negative control, or in preparation of a positive control for diagnostic kit production.

Large number of donors per liter results in a "normalized" product

Human Serum Off Clot

True Human Serum

DNSERUM

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Normal Human Plasma

Plasma products are obtained from donors at FDA-registered US blood centers and delivered with full traceability.

Custom bottling and processing options are available.

Product
Category
Features

Normal Human Plasma, 3 Negative

This Normal Human Plasma product is derived from patient samples that were tested and found negative for anti-HIV 1/2, HBsAg, anti-HCV, HIV-1 Ag and/or HIV-1 RNA and HCV RNA. For research use only.
Fill size 1.5 mL More.

Human Fresh Frozen Plasma (FFP)

This Human Fresh Frozen Plasma was tested and found negative for anti-HIV 1/2, anti-HCV, and HBsAg. Patient samples were frozen within 8 hours of collection. For research use only.
Fill size 1 Liter More.

Human Plasmapheresis Plasma

This Human Plasmapheresis Plasma product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for anti-HIV 1/2, HBsAg, anti-HCV, HIV-1 Ag and/or found non-reactive by licensed Nucleic Acid Tests for HIV-1 RNA and HCV RNA performed on pooled samples. For research use only.
Fill size 250 mL More.

Recovered Human Plasma Liquid

This Recovered Human Plasma Liquid product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for anti-HIV 1/2, HIV-1 Ag, HBsAg, HTLV I/II, anti-HBc, and anti-HCV. For research use only.
Fill size Price $/mL (sold in units) More.

Recovered Human Plasma Frozen

This Recovered Human Plasma Frozen product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for anti-HIV 1/2, HIV-1 Ag, HBsAg, HTLV I/II, anti-HBc, anti-HCV, and RPR. ALT within normal limits. For research use only.
Fill size Price $/mL (sold in units) More.

NORMPLSM

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Processed Human Plasma (including SeraCon)

SeraCon products are cost-effective human serum substitutes for use as diluent and cell culture media.

SearCare Basematrix is a fully processed and characterized defibrinated human plasma matrix for preparing your assay controls, calibrators, and reference standards.

Product
Category
Features

SeraCon Matribase

Synthetic plasma/serum substitute is available for use as a universal base matrix.
Fill size 1 Liter More.

SeraCon I

This custom processed human plasma is suitable for diluent as a base matrix in preparing controls, and for cell culture growth media. Defibrinated, pooled plasma, 0.2 μm filtered. Affinity stripping is available.
Fill sizes 3.5 Liters More. 1 Liter More.

SeraCon II

This custom processed human plasma is suitable for diluent as a base matrix in preparing controls, and for cell culture growth media. It contains SeraCon I (defibrinated, pooled plasma, 0.2 μm filtered) dialyzed to approximate a human serum profile. Affinity stripping is available.
Fill size 3.5 Liters More.

SeraCon II Female delipidated

This custom processed human female plasma is suitable for diluent as a base matrix in preparing controls, and for cell culture growth media. It contains SeraCon I (defibrinated, pooled plasma, 0.2 μm filtered) dialyzed to approximate a human serum profile, and delipidated for clarity/stability. Affinity stripping is available.
Fill size 1 Liter More.

SeraCon II Male delipidated

This custom processed human male plasma is suitable for diluent as a base matrix in preparing controls, and for cell culture growth media. It contains SeraCon I (defibrinated, pooled plasma, 0.2 μm filtered) dialyzed to approximate a human serum profile, and delipidated for clarity/stability. Affinity stripping is available.
Fill size 1 Liter More.

SeraCon II

SeraCon II D

This custom processed human plasma is suitable for diluent as a base matrix in preparing controls, and for cell culture growth media. It contains SeraCon I (defibrinated, pooled plasma, 0.2 μm filtered) dialyzed to approximate a human serum profile, and delipidated for clarity/stability. Affinity stripping is available.
Fill sizes 3 Liters More. 1 Liter More.

SeraCon II CD

This custom processed human plasma is suitable for diluent as a base matrix in preparing controls, and for cell culture growth media. It contains SeraCon I (defibrinated, pooled plasma, 0.2 μm filtered) dialyzed to approximate a human serum profile, delipidated for clarity/stability, and charcoal stripped. Affinity stripping is available.
Fill sizes 3 Liters More. 1 Liter More.

Basematrix 53, 1L processed plasma

Basematrix 53 is a processed defibrinated human plasma product derived from plasma collected at FDA-licensed facilities in the US. Detailed Certificate of Analysis provided. For research use only.
Fill size 1 Liter More.

Basematrix, 12 x 3.5 mL

Basematrix Diluent is formulated for use with in vitro diagnostic test kits for the detection of HBV DNA, HCV RNA, HIV-1 RNA, Human Parvovirus B19 DNA, HAV RNA, HBsAg, anti-HIV 1/2, anti-HTLV I/II, anti-HBc, and anti-HCV. The product is manufactured from defibrinated human plasma that is negative for HBV DNA, HCV RNA, HIV-1 RNA, Human Parvovirus B19 DNA, and HAV RNA, and non-reactive for HBsAg and anti-HIV-1/2, anti-HCV, anti-HTLV I/II, anti-HBs, and anti-HBc. For research use only.
Fill size 12 x 3.5 mL More.

Negative Human Base Matrix

This Negative Human Base Matrix product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for anti-HIV 1/2, HIV-1 Ag, HBsAg, anti-HCV, and RPR. ALT within acceptable limits. For research use only.
Fill size 1 Liter More.

Human Plasma, Sterile for cell culture

This Human Plasma product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for RPR, anti-HIV 1/2, HBsAg, anti-HCV, HIV-1 Ag, and/or found non-reactive for HIV-1 RNA and HCV RNA. Sterile, male AB human plasma. For research use only.
Fill size 100 mL More.

SERACON

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Human Serum Off Clot

Plasma products are obtained from donors at FDA-registered US blood centers and delivered with full traceability. Our regimen of viral screening and full traceability is designed to ensure the highest level of confidence.

Custom bottling and processing options are available.

Product
Category
Features

Human Serum, off clot, 3 Negative for viral markers

This Human Serum Off Clot product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for anti-HIV 1/2, HBsAg, HIV-1 Ag, anti-HCV, and RPR. For research use only.
Fill size $/mL (full units only) More.

Human Serum, off clot, Female, 3 Negative for viral markers

This Human Serum Off Clot Female product is derived from patient samples that were tested and found negative for anti-HIV 1/2, HBsAg, and anti-HCV. For research use only.
Fill size $/mL (full units only) More.

Human Serum, off clot, Male, 3 Negative for viral markers

This Human Serum Off Clot Male product is derived from patient samples collected at FDA-licensed facilities in the US. Samples were tested and found negative for anti-HIV 1/2, HBsAg, HIV-1 Ag, anti-HCV, and RPR. For research use only.
Fill size $/mL (full units only) More.

OCLOTSER

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True Human Serum

Product
Category
Features

Human Serum, pooled filtered, 3 Negative for viral markers

This Pooled True Human Serum product is derived from serum tested and found negative for anti-HIV 1/2, anti-HCV, HIV Ag and/or NAT, and HBsAg. For research use only.
Fill size 3.5 Liter More.

Human Serum, pooled filtered, 3 Negative for viral markers

This Pooled True Human Serum product is derived from serum tested and found negative for anti-HIV 1/2, HBsAg, and anti-HCV. For research use only.
Fill size $/mL (full units only) More.

Human Serum, pooled filtered, 3 Negative for viral markers

This Pooled True Human Serum product is derived from serum tested and found negative for anti-HIV 1/2, HBsAg, and anti-HCV. For research use only.
Fill size $/mL (full units only) More.

Human Serum, pooled filtered, 5 Negative for viral markers

This Pooled True Human Serum product is derived from serum tested and found negative for anti-HIV 1/2, HBsAg, and anti-HCV. For research use only.
Fill size $/mL (full units only) More.

THSER

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Bulk, OEM, and Custom Products

SeraCare Configures To You

When you require

•   large quantities
•   specialized packaging, or
•   custom product configuration

SeraCare will work with you to develop the best solution.

Our facilities are ISO certified and meet cGMP practices, and we have expertise in virology, immunology, molecular biology, and biochemistry.

Your needs will be satisfied.

BULK

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Product Features & Benefits


	SeraCare plasma and serum products are

	•	supplied as individual units, pooled, delipidized, or custom processed

	•	tested negative or non-reactive by FDA-licensed tests for infectious disease analytes anti-HIV-1/2, HBsAg, anti-HCV, and other selected markers

	•	traceable back to the donor, with additional information such as donor age, sex, and geographic information available upon request — paid and volunteer donors are verbally and physically screened in compliance with the highest level of FDA regulations

	•	available in quantities ranging from 10 mL to thousands of liters and/or single units — pricing is based upon quantity ordered and information requested — supply agreements and long-term contracts are available

PLASMA-P

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Safety & Quality Profile


	•	Donor, pooling, and final product records reviewed and maintained by our quality assurance department in accordance with FDA requirements

	•	Raw material and in-process inventory screening through final confirmation

	•	Reference samples of each lot maintained for minimum two years

	•	Product testing in our quality control department using standard clinical chemistry and serology methods

	•	Manufactured in Class 100,000 clean room, facilities are ISO 13485 certified and cGMP compliant

	•	0.2µM filtered before bottling

PLASMA-S

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Product Features & Benefits


	•	Naturally clotted

	•	Obtained from volunteer donors at FDA-registered US blood centers

	•	Lots over 500 L available, helps reduce requirement for user validation

	•	Excellent lot-to-lot reproducibility

	•	Custom bottling and custom processing options

	•	Certificate of Analysis supplied with each lot, confirming donor units have tested negative or non-reactive for anti-HIV-1/2, anti-HCV, and HBsAg

	•	Complete donor traceability maintained

	•	Donor units can be further certified for non-reactivity in assays for aHBc, aHTLV-1/2, and RPR

SERUM-P

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Safety & Quality Profile


	•	Donor, pooling, and final product records reviewed and maintained by our quality assurance department in accordance with FDA requirements

	•	Raw material and in-process inventory screening through final confirmation

	•	Reference samples of each lot maintained for minimum two years

	•	Product testing in our quality control department using standard clinical chemistry and serology methods

	•	Manufactured in Class 100,000 clean room, facilities are ISO 13485 certified and cGMP compliant

	•	0.2µM filtered before bottling

SERUM-S

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Product Features & Benefits


	•	Processed plasma customized to your specifications—options include defribination, delipidation, and more

	•	Visually clear, free of precipitate, virtually free of particulate

	•	Low bio-burden: routinely < 10 colony forming units (CFU) per mL

	•	Salt balanced close to physiological conditions

	•	Custom packaging and processing available, including large lots, gender pre-selection

	•	Donor units may be further certified for nonreactivity in assays for anti-HBc, anti-HTVL-I/II, and syphilis

SCON-P

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Safety & Quality Profile


	•	Regimen of full traceability and viral screening ensures a high level of confidence, quality, and safety

	•	Donor unit screening uses FDA-approved test methods

	•	Test records—at the donor unit, pooling, and finished-product stages—are reviewed and maintained by our quality assurance department in accordance with FDA requirements

	•	SeraCare’s manufacturing facilities are ISO 13485 certified and cGMP compliant

SCON-S

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GPS Test Locator Tool


	•	Only the SeraCare GPS program offers a searchable database of available tests (more than 2,000 in total)

	•	Find the tests you need in seconds

	•	Type the names of the tests into the box on the Request Form, hit send, and we will provide a list of available samples

	•	Quick and easy as it gets

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	A wide range of high-quality, highly-characterized HIV Cultured Virus

	•	45 isolates from 17 countries, including Group M subtypes A-H and Group O

	•	Purified RNA available for selected isolates

	•	For use in research, drug candidate screening, assay development, and method validation

	•	Viral quantitation by electron microscopy, RNA quantitation by nucleic acid assays

	•	Verification of isolate identity by sequence analysis

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Product Features & Benefits


	•	Enhance quality control and quality assurance in your testing lab

	•	Human plasma based controls mimic patient samples

	•	Independent controls meet compliance requirements of regulatory agencies and professional organizations

	•	Liquid, ready-to-use—no reconstitution or special handling required

	•	Extended shelf life means efficiency for your lab, allows you to monitor assay performance with same lot over an extended period of time

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Product Features & Benefits


	•	SeraCare's extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent, assay/platform performance, sensitivity, and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Minimizes down time and accelerates verification of new test methods, reagent systems, and platforms

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	Routine use of independent controls helps your lab monitor day-to-day test variability, lot-to-lot variability, and staff performance

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Safety & Quality Profile


	•	SeraCare panels are rigorously tested and characterized using the highest quality test methods

	•	Comprehensive test results provided with each panel — Quantified against international standards when available

	•	Long-term stability and availability

	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent, assay, and platform performance, sensitivity and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Available for most instrument platforms and test methods

	•	Minimizes down time and accelerates verification of new test methods and platforms

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Safety & Quality Profile


	•	Rigorously tested and characterized using highest-quality test methods

	•	Comprehensive test results provided with each panel — Quantified against international standards when available

	•	Long-term stability and availability

	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Safety & Quality Profile


	•	Rigorously tested and characterized using highest-quality test methods

	•	Comprehensive test results provided with each panel — Quantified against international standards when available

	•	Long-term stability and availability

	•	SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent assay/platform performance, sensitivity, and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Minimizes down time and accelerates validation and verification of new test methods, reagent systems, and platforms

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent, assay, and platform performance, sensitivity and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Available for most instrument platforms and test methods

	•	Minimizes down time and accelerates verification of new test methods and platforms

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Safety & Quality Profile


	•	Rigorously tested and characterized using highest-quality test methods

	•	Comprehensive test results provided with each panel — Calibration against international standards when available

	•	Long-term stability and availability

	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	Purified HIV-1 RNA is available for selected isolates of highly-characterized HIV Cultured Virus

	•	For use in research, drug candidate screening, assay development, and method validation

	•	Viral quantitation by electron microscopy, RNA quantitation by nucleic acid assays

	•	Verification of isolate identity by sequence analysis

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	High-quality, highly-characterized HIV cell culture supernatant

	•	Non-infectious Reverse Transcriptase (RT) mutant

	•	For use in research, drug candidate screening, assay development, method validation, and manufacture

	•	RNA quantitation by nucleic acid assays

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	Negative for HIV, HBV, HCV, HTLV, and Syphilis

	•	Apheresis-derived

	•	Shipped fresh

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	SeraCare is compliant with all Good Practices, including GLP and GCP

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SeraCare Experience


•	We are 30 years into serving customers, including the NIH, CDC, and FDA

•	We have successfully participated in some of the most demanding clinical trials of the past decade

•	We manage every size collection—a hundred samples to a million, including
	—	cell banks, tissue, sera, plasma, slides, and nucleic acids

•	We are GxP compliant with flexibility to adjust to your requirements, protocols, or procedures

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Product Features & Benefits


	Our disease state collection ranks among the largest and most diverse. Materials can be:

	•	Characterized in our ISO-certified labs to meet a wide variety of reactivity profiles

	•	Processed to meet your needs

	•	Sourced to your specifications

	•	Available from both individual donors and pools

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Safety & Quality Profile


•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

•	Complete donor traceability and quality control
	—	Materials are fully documented

•	Detailed Certificates of Analysis provided

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Product Features & Benefits


	•	Thoroughly tested to ensure highest levels of quality and consistency

	•	Chemistry profiles available upon request

	•	Serum reproducible in lot sizes to 1000 L

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Safety & Quality Profile


	•	Produced in Class 100,000 and Class 100 clean rooms

	•	Serum aseptically filtered to 0.2 µM or 0.1 µM (product dependent)

	•	Traceable raw material with Certificates of Origin available upon request

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Product Features & Benefits


	•	High purity

	•	Complete origin traceability—facilitates regulatory approval

	•	Excellent solubility/filterability—for ease of use

	•	Validation for clearance of TSE agents

	•	IgG–free—virtually free of potential background-interference contaminants

	•	Responsive customer and technical support

	•	Sample sizes are available upon request

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Safety & Quality Profile


	•	Our BSA is a high-purity “Fraction V” protein—derived from plasma of US-origin, USDA-inspected, healthy animals

	•	Typical purity levels > 99%—BSA is initially fractionated by a modified Cohn procedure and further isolated from other plasma proteins and lipids by extensive membrane dialysis and filtration

	•	Produced in adherence to FDA Bulk Pharmaceutical Chemicals cGMP

	•	All SOPs and batch records demonstrating compliance are on file, available for inspection

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Product Features & Benefits


	•	Lot-to-lot consistency from large, repeat donor pool

	•	Plasma products are obtained from donors at FDA-registered US blood centers and delivered with full traceability

	•	Custom bottling and processing options are available

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Safety & Quality Profile


	•	Certificate of Analysis with each lot

	•	Product testing in our quality control department using standard clinical chemistry and serology methods

	•	Facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	We have served as the central laboratory for NIAID-sponsored vaccine trials (since 1998) and for the Cancer Vaccine Consortium ELISpot proficiency program—a consortium of 35 academic and biopharmaceutical laboratories

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Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	Continuing education and performance benchmarking are mandated for all SeraCare technicians and scientists

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SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	Our molecular biology group is expert in DNA and RNA isolations, northern and southern blotting, PCR amplification, in situ hybridization and DNA cloning/sequencing

	•	We are well-equipped to perform a wide range of nucleic acid processing and DNA analysis, and we have ongoing competency evaluation and training programs for all molecular activities

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SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	We have been performing basic fractionization of serum and plasma and PBMC isolation for more than 20 years

	•	We currently perform PBMC isolations and cryopreservation in support of several clinical trials and government research contracts

	•	Typical purity is 0.5-3.0 x 10⁶ PBMCs per whole mL of blood, with greater than 90% viability.

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SeraCare Experience


	•	We are 30 years into serving customers, including the NIH, CDC, and FDA

	•	We have successfully participated in some of the most demanding clinical trials of the past decade

	•	We have extensive expertise in Biochemistry, Molecular Biology, PBMC Isolation, and Virology and Immunology

	•	Our virology and immunology group has a well-established success record in cell and virus culture, including original propagation and cultivation of a wide range of retroviruses from clinical samples

	•	We have developed and implemented a large number of immunological tests, utilizing various platforms

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Product Features & Benefits


•	A continuous supply of high-quality HSA, in stock and available for rapid delivery

•	Customer friendly flexibility in sampling

•	SeraCare has formed a distribution partnership with Octapharma AG, the largest, privately-held manufacturer of therapeutic HSA in the world

•	Our best-in-class technical support
	—	Now backed by world-wide HSA sourcing and manufacturing capability
	—	2.6 million liters of plasma processed annually

•	Our service to customers who depend on consistent delivery of high-quality HSA
	—	Brought to a whole new level through our affiliation with a company dedicated to plasma-derivative development and manufacture

•	Sample sizes are available upon request

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Safety & Quality Profile


•	SeraCare delivers a pure HGG product, consistent batch-to-batch
	—	Contact us for a sample Certificate of Analysis

•	All SeraCare HSA products are FDA licensed and utilize plasma from US donors

•	Our HSA is contained in a sterile, aqueous solution derived from human plasma, collected only from FDA-approved donation centers
	—	Plasma units are rigorously screened for anti-HIV-1/HIV-2, HBsAg, anti-HCV, and HIV-1 Ag and/or HIV-1 NAT

•	State-of-the-art HSA manufacturing methods are designed to significantly reduce viral contamination
	—	Cold ethanol fractionation is followed by ultrafiltration, diafiltration, heat treatment, and multiple pasteurization processes

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Product Features & Benefits


	•	A continuous supply of high-quality HGG, in stock and available for rapid delivery

	•	Customer Friendly flexibility in sampling

	•	Our service to customers who depend on a consistent delivery of high-quality HGG

	•	Sample sizes are available upon request

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Safety & Quality Profile


•	SeraCare delivers a pure HGG product, consistent batch-to-batch
	—	Contact us for a sample Certificate of Analysis

•	Our HGG is derived from human plasma, collected only from FDA-approved donation centers

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Product Features & Benefits


	•	Serum-free formulation provides consistency and reliability against biologic variability

	•	Completely animal-free formula significantly reduces possible contamination

	•	Post-thaw PBMC functionality is equivalent to fresh cells prior to cryopreservation

	•	Made to order

	•	Custom-sized lots available

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


•	For use in any solid-phase assay with an Alkaline Phosphatase amplification/detection system, including AP-conjugated antibodies and AP-conjugated avidin

•	Suitable for a variety of protocols
	—	including protein dot blots or slot blots, Western blots, coated beads, coated sampling devices such as dipsticks or flow-through sample/assay chambers, and DNA or RNA filter hybridizations on Southern or Northern blots or dot blots

•	Deposits a long-lasting dark purple spot at the AP binding site on membrane or solid support

•	Proven lot to lot consistency

•	Convenient, provided as a single, stabilized reagent for use directly from the bottle

•	Custom bottle sizes available

•	Store at 2 to 8º C

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	Exceptional sensitivity and high signal-to-noise ratios deliver rapid, accurate, test results

	•	Lot specific Certificate of Analysis

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Product Features & Benefits


	Product Features & Benefits

	•	Average lot viability greater than 90% enables functional assays

	•	Average lot purity greater than 90% assures cell homogeneity

	•	Functionality comparable to fresh cells delivers consistency

	•	Animal free and serum free formulation minimizes biologic variability

	•	Ethical collection and viral testing means less upfront documentation and logistics


	Off the Shelf Availability

	•	Shipped in 24 hours

	•	Substantial same lot inventory enables assay to assay comparison and consistency

	•	Validated lots for reliable and dependable performance


	Characterization and Demographic Information Includes

	•	Age, gender, ethnicity

	•	HLA typing (low resolution, Class I genes)

	•	Cytokine (IFN-γ) responses to CEF and CMV peptide pools, PHA, and specific peptides/immunogens

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Safety & Quality Profile


•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

•	Complete donor traceability and quality control
	—	Materials are fully documented in anticipation of regulatory filings

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Product Features & Benefits


•	For use in Western blots, dot blots, and other membrane-capture assay applications

•	For use in enzyme immunoassays
	—	microtiter plate, tube, or automated formats

•	Proven lot to lot consistency

•	Convenient, provided as a single, stabilized reagent for use directly from the bottle

•	91000 and 91200 products provide excellent signaling, suitable for quantitative immunoassays

•	Ideal for automation

•	Ultra Blue™ soluble substrate delivers enhanced signal intensity over TM Blue™

•	Store at 2 to 8º C

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	High sensitivity of the HP substrate means rapid results

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Product Features & Benefits


	•	Processed plasma customized to your specifications—options include defibrination, delipidation, and more

	•	Visually clear, free of precipitate, virtually free of particulate

	•	Low bio-burden: routinely < 10 colony forming units (CFU) per mL

	•	Custom packaging and processing available, including large lots, gender pre-selection

	•	Donor units may be further certified for nonreactivity in assays for anti-HBc, anti-HTLV-I/II, and Syphilis

	•	Sample sizes are available upon request

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP regulations

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Safety & Quality Profile


	•	Regimen of full traceability and viral screening ensures a high level of confidence, quality, and safety

	•	Donor unit screening uses FDA-approved test methods

	•	Test records—at the donor unit, pooling, and finished-product stages—are reviewed and maintained by our quality assurance department in accordance with FDA requirements

	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


•	Precise morphology of spot forming cells (SFCs)
	—	Detection limit of one SFC per well, validated linearity of 10-800 SFCs per well

•	Identical technology as used in many clinical trials

•	Compatible with commercially available ELISpot analysis instruments, kit contains two pre-coated, pre-blocked plates and detection reagents

•	State-of-the-art, automated plate manufacturing process delivers a high degree of precision, well to well and plate to plate, compatible with any 96-well format

•	Manufacturing capability up to 100 kits per lot, for consistency

•	Shipped within 24 hours, shelf life at least one year

•	Multiple species and cytokines available, custom orders available upon request

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Product Features & Benefits


SeraCare plasma and serum products are

•	supplied as individual units, pooled, delipidized, or custom processed

•	tested negative or non-reactive by FDA-licensed tests for infectious disease analytes anti-HIV-1/HIV-2, HBsAg, anti-HCV, and other selected markers

•	traceable back to the donor, with additional information such as donor age, sex, and geographic information available upon request
	—	paid and volunteer donors are verbally and physically screened in compliance with the highest level of FDA regulations

•	available in quantities ranging from 10 mL to thousands of liters and/or single units
	—	pricing is based upon quantity ordered and information requested
	—	supply agreements and long-term contracts are available

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Safety & Quality Profile


	•	Donor, pooling, and final product records reviewed and maintained by our quality assurance department in accordance with FDA requirements

	•	Raw material and in-process inventory screening through final confirmation

	•	Reference samples of each lot maintained for minimum two years

	•	Product testing in our quality control department using standard clinical chemistry and serology methods

	•	Manufactured in Class 100,000 clean room, facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	Naturally clotted

	•	Obtained from volunteer donors at FDA-registered US blood centers

	•	Excellent lot-to-lot reproducibility

	•	Custom bottling and custom processing options

	•	Certificate of Analysis supplied with each lot, confirming donor units have tested negative or non-reactive for anti-HIV-1/2, anti-HCV, and HBsAg

	•	Complete donor traceability maintained

	•	Donor units can be further certified for non-reactivity in assays for anti-HBc, anti-HTLV-1/2, and RPR

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Safety & Quality Profile


	•	Donor, pooling, and final product records reviewed and maintained by our quality assurance department in accordance with FDA requirements

	•	Raw material and in-process inventory screening through final confirmation

	•	Reference samples of each lot maintained for minimum two years

	•	Product testing in our quality control department using standard clinical chemistry and serology methods

	•	Manufactured in Class 100,000 clean room, facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	High purity

	•	Complete origin traceability—facilitates regulatory approval

	•	Excellent solubility/filterability—for ease of use

	•	Validation for clearance of TSE agents

	•	Responsive customer and technical support

	•	Sample sizes are available upon request

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Product Features & Benefits


	•	Thoroughly tested to ensure highest levels of quality and consistency

	•	Chemistry profiles available upon request

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Product Features & Benefits


	•	A continuous supply of high-quality HSA, in stock and available for rapid delivery

	•	Customer friendly flexibility in sampling

	•	Our service to customers who depend on consistent delivery of high-quality HSA

	•	Sample sizes are available upon request

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Safety & Quality Profile


	•	SeraCare delivers a pure HSA product, consistent batch-to-batch — Contact us for a sample Certificate of Analysis

	•	Our HSA is derived from human plasma, collected only from FDA-approved donation centers

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Product Features & Benefits


	•	Thoroughly tested to ensure the highest levels of quality and consistency

	•	Traceable and well documented products for use in basic research and for development through manufacturing

	•	Please inquire about custom sizes and packaging

	•	Responsive customer and technical support

	•	Sample sizes are available upon request

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Product Features & Benefits


	•	Thoroughly tested to ensure the highest levels of quality and consistency

	•	Chemistry profiles included on detailed Certificate of Analysis

	•	Traceable and well documented products for use in basic research and for development through manufacturing

	•	Please inquire about custom sizes and packaging

	•	Responsive customer and technical support

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Product Features & Benefits



	•	SeraCare specialty blood products are tested negative or non-reactive by FDA-licensed tests for infectious disease analytes anti-HIV-1/HIV-2, HBsAg, anti-HCV, and other selected markers

	•	Paid and volunteer donors are verbally and physically screened in compliance with the highest level of FDA regulations

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Safety & Quality Profile


	•	All animals of US origin

	•	Serum aseptically filtered to 0.2 µM or 0.1 µM (product dependent)

	•	Traceable raw material with Certificates of Origin available upon request

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Product Features & Benefits


	•	Enhance quality control and quality assurance in your testing lab

	•	Controls mimic patient samples

	•	Independent controls meet compliance requirements of regulatory agencies and professional organizations

	•	Liquid, ready-to-use—no reconstitution or special handling required

	•	Long shelf life saves time, allows you to monitor assay performance with same lot of control

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Product Features & Benefits


	•	Naturally clotted

	•	Obtained from volunteer donors at FDA-registered US blood centers

	•	Excellent lot-to-lot reproducibility

	•	Custom bottling and custom processing options

	•	Certificate of Analysis supplied with each lot, confirming donor units have tested negative or non-reactive for anti-HIV-1/2, anti-HCV, and HBsAg

	•	Donor units can be further certified for non-reactivity in assays for anti-HBc, anti-HTLV-1/2, and RPR

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Product Features & Benefits


	•	Multiple allele controls, including the most relevant alleles, allow your lab to optimize instrument capacity

	•	Human genomic DNA controls mimic patient samples more closely than synthetic DNA controls

	•	As genomic DNA, our controls perform efficiently on most platforms

	•	Single-use, ready-to-use vials reduce risk of contamination

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Safety & Quality Profile


	•	External validation delivers consistent quality and eliminates HIPAA compliance concerns that may arise from use of remnant patient samples

	•	High purity, genomic DNA—no additional processing required; mutations confirmed by rigorous DNA sequencing

	•	Single-use, ready-to-use vials increase assay throughput, save time, and reduce or eliminate possibility of contamination

	•	SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits


	•	Enhance quality control and quality assurance in your testing lab

	•	Human plasma based controls mimic patient samples

	•	Independent controls meet compliance requirements of regulatory agencies and professional organizations

	•	Liquid, ready-to-use, single vial—no reconstitution or special handling requirements

	•	Extended shelf life means efficiency for your lab, allows you to monitor assay performance with same lot over an extended period of time

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	Routine use of independent controls helps your lab monitor day-to-day test variability, lot-to-lot variability, and staff performance

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Safety & Quality Profile


	•	SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	Independently validated controls monitor instrument performance, simplify QC procedures, and help meet regulatory requirements in an increasingly stringent environment

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Product Features & Benefits


	•	Eliminate errors arising from use of rotating gDNA control schemes with incomplete mutation profiles

	•	Eliminate "no-calls" QC results—only ACCURUN controls contain a mixture of oligonucleotides that produce a call for every mutation tested

	•	All mutations contained in a single vial

	•	High purity, large lots, stable materials—no additional processing required

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Product Features & Benefits


	•	Transcribed RNA containing viral sequences for InfA, Universal Swine, Swine H1, and RNase P

	•	For use in research, assay development, and method validation

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

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Product Features & Benefits



	•	Visually clear, free of precipitate, virtually free of particulate

	•	Low bio-burden: routinely < 10 colony forming units (CFU) per mL

	•	Salt balanced close to physiological conditions

	•	Custom packaging and processing available, including large lots, gender pre-selection

	•	Donor units may be further certified for nonreactivity in assays for anti-HBc, anti-HTLV-I/II, and Syphilis

	•	Sample sizes are available upon request

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Safety & Quality Profile


	•	All products produced in accordance with ISO standards in state of the art cGMP facilities

	•	Certificates of Analysis, real time Stability Data, MSDS, and detailed Instruction Manual available for each product

	•	Reagents are water based and contain no harmful or flammable substances

	•	Reliable lot to lot consistency proven in real time studies

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Product Features & Benefits


•	Wide range of substrates and buffers available

•	Innovative product options, including:
	—	Prestained liquid TMB reagents with red tint, making it easier to follow pipetting and reduce potential error with no interference to indicator color
	—	Fizzing, buffered tablet form available for AEC, DAB, and OPD; dissolves in water faster than standard tablets for improved efficiency and ease of use

•	Exceptional sensitivity and high signal-to-noise ratios deliver rapid, accurate test results

•	Reagents are ready to use, many with an industry leading shelf life of up to four years when stored at 4º C and many years longer when stored at -20º C

•	Custom reagent development, custom labeling, and custom bottling available

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Product Features & Benefits


	•	For use in immunoassays with horseradish peroxidase (HRP) conjugated antibodies

	•	Produces a blue color during incubation when binding occurs with HRP

	•	Large lots available, up to 750L

	•	Proven lot to lot consistency

	•	Convenient. Provided as a single, stabilized reagent for use directly from the bottle

	•	Custom bottle sizes available

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Product Features & Benefits


	•	All in one kits streamline and accelerate your initial immunoassay evaluation process

	•	Kit components are scalable, with minimum two year shelf life

	•	Compatible with commercially available, 96 well plate handling and analysis instrumentation

	•	Reliable end to end performance with validated components and precise resolution of Spot Forming Cells (SFCs)

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Product Features & Benefits


•	Functionality equivalent to fresh cells

•	Post-thaw viability exceeds 80%, 5 million cells per mL

•	Serum-free formulation means less biologic variability

•	Completely animal free, ethically collected, no breach of privacy

•	Characterization and demographic information includes
	—	Donor age, gender, ethnicity
	—	HLA typing (low resolution, Class I genes)
	—	Serological and NAT viral testing

•	Large lots available to support long-term and inter-lab data comparisons

•	Healthy and disease state donors

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Product Features & Benefits


	•	Processed plasma customized to your specifications—options include defibrination, delipidation, and more

	•	Visually clear, free of precipitate, virtually free of particulate

	•	Salt balanced close to physiological conditions

	•	Low bio-burden: routinely < 10 colony forming units (CFU) per mL

	•	Custom packaging and processing available, including large lots, gender pre-selection

	•	Donor units may be further certified for nonreactivity in assays for anti-HBc, anti-HTLV-I/II, and Syphilis

	•	Sample sizes are available upon request

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Product Features & Benefits


	•	Suitable for horseradish peroxidase (HRP) blotting assays

	•	Deposits a long lasting blue spot at the HRP binding site on the membrane with low background staining

	•	Large lots available, up to 100L

	•	Proven lot to lot consistency

	•	Convenient. Provided as a single, stabilized reagent for use directly from the bottle

	•	Custom bottle sizes available

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Product Features & Benefits


	•	For use in any solid phase assay with an Alkaline Phosphatase (AP) detection system, including AP-conjugated antibodies and AP-conjugated avidin

	•	Suitable for a variety of protocols

	•	Deposits a long lasting dark purple spot at the AP binding site on membrane or solid support

	•	Proven lot to lot consistency

	•	Convenient. Provided as a single, stabilized reagent for use directly from the bottle

	•	Custom bottle sizes available

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Safety & Quality Profile


	•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

	•	High sensitivity of the AP substrate means rapid results and a high degree of definition in blot assays