SeraCare Life Sciences Your Total Solutions Partner

The SeraCare Mission

SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, validation and production of human diagnostics and therapeutics.

Facilities and Locations

SeraCare Life Sciences Headquarters, ManufacturingMilford, MA USA

SeraCare Life Sciences R&D, BioServices, Manufacturing

Gaithersburg, MD USA

SeraCare Life SciencesBioServices- Repository Frederick, MD USA

SeraCare’s Portfolio of Products and Services

SERVICES

• High quality purified biological products and materials for development and manufacture therapeutics, vaccines and diagnostics

• Readily available plasma-derived diagnostic intermediates

• Sourcing and Purification of custom intermediates

• ACCURUN® and custom controls and performance panels verify accuracy of diagnostic tests

• Comprehensive portfolio of infectious disease controls readily available

• Controls developed for low level positive with targeted assays

• Extensive Library of viral isolates

• Design and Development of Proficiency Panel components

• Extensive sample management capabilities including:

Site training, collection kit distribution, storage, data analysis

• Contract research in molecular biology, virology, immunology and biochemistry

• Consultative assay development and production

Controls & Panels Clinical Trials & Central Processing Laboratory

Reagents & Bioprocessing Products

PRODUCTS

Raw Material Procurement

Streamline Sourcing & Maximize Development Time

• Source Plasma & Reclaimed human plasma • Extensive inventory characterized infectious & non infectious materials• Remnant and Prospective Patient Sample collection • Human Plasma

• EDTA, Citrate Heparinized, Fresh-frozen, Recovered, Source

• Whole Blood and Serum • Off-the-Clot Serum (male or female)• Whole blood, Red cells, Leukopaks, Bone Marrow

• Human Liquids-amniotic fluid, urine, synovial fluid, cord serum

• High purity Human Albumin Powders and Liquids• Established long term relationships with suppliers• Regulatory Compliance• Custom processing capabilities

Processed Human Plasma/Serum

Minimize Interference and Improve Sensitivity with High Quality Processed Human Plasma

• cGMP Manufacturing• Stable serum substitute• Clear and precipitate free• Sterile filter capability• Consistent lot to lot chemistry profile• Low bioburden <10 cfu/ml

SeraCon Applications

• Processed human plasma: an industry proven human serum substitute

• Ideal for use as a diluent in preparing in-kit calibrators and controls

• Well-suited for in vitro diagnostic and clinical chemistry use

Manufacturing Capabilities

• Certified cleanrooms-class 100,000

• Dedicated processing equipment

• Validated equipment and processes

• Batch capacity up to 1,800 liters

• Defibrination/Delipidation

• Filtration

• Dialysis/Ultra-filtration

• Resin and chemical stripping

• Aseptic dispensing

• Viral reduction treatment (UV, βPL, Heat)

• Lyophilization

• Protein purification

SeraCare Panels Accelerate development and validation with

highly characterized sample sets

• Unique collections representing diverse populations

• Rigorously tested with the most current test methods

• Comprehensive data summary readily provides assay comparison

• Minimally processed plasma or viral isolates

• Establish assay sensitivity

• Wide array of infectious disease markers, both serology and NAT

• HIV, HBV, HCV, HAV, ToRCH, EBV, Chagas, Syphilis, Lyme, HBsAg, HTLV I/II, CMV, Dengue

SeraCare Panel Products

Performance Panels

• Undiluted samples collected from multiple donors of varied analyte concentration, genotype and ethnic/demographic diversity

• Offer a wide range of reactivities and comprehensive data for

comparing test methods

Seroconversion Panels

• Undiluted samples collected from a single donor during development of infection and subsequent immune response

• Provide important information on the viral ‘window period’ and human immune response for research and diagnostics

Assembled from actual, individual and undiluted human samples to mimic actual patient samples

Compatible with all platforms and test menus that can use previously frozen plasma

SeraCare Panel Products

Qualification Panels

• Sample sets for training staff, assessing competency and troubleshooting tests.

• Contain one negative and five diluted positive members that span the dynamic range of most test methods

Sensitivity and Linearity Panels

• Serially diluted patient samples designed to evaluate reportable range and low-end sensitivity of the test method

ACCURUN® Controls

Manufacturers and Clinical Labs rely on consistent control materials to monitor assay performance

• Human plasma and cell based controls mimic patient samples• Verify all aspects of assay from extraction to amplification and detection • No special handling or reconstitution needed• Formulated to provide low level positive performance• Single and multi-analyte controls: • Compliant with regulatory guidelines• Stable at refrigerated temperatures• Independent run controls meet quality requirements of regulatory agencies

and professional organizations

Comprehensive selection of infectious disease markers, both serology and NAT

• HIV-1/2, HAV, HBV, HCV, HTLV-1/2, HPV, ToRCH, Syphilis, Ct /Ng, EBV, Parvovirus, Measles, Mumps, VZV, Lyme, WNV, Chagas, CF

Total OEM Solution for Customized Reagents and Kits

Manufacturing Service Capabilities (36,000 ft2)

Custom calibrator & control design and scale up• Custom product design & technical support • Intact organisms (infectious/noninfectious)• Engineered & recombinant analytes

Formulation optimization

Stability testing

Product Fill & Packaging• ISO 8 clean rooms• Bulk fills • Lyophilization and dry-down chemistries• Custom labeling• Automated vial fills

Custom Manufacturing

Technical Services

ACCUTYPE Manufacture and Distribution

Proficiency Panels

• Provide a full range of disease-state plasma/serum to national and international proficiency programs world-wide

Markers: Anti-HIV ½, HBsAg, Anti-HCV, HBeAg, Anti-HBe, Anti-HBc, Anti-HTLV, Syphilis, HIV RNA, HCV RNA, HBV DNA, Anti-Toxo, Anti-Rubella, Anti-CMV, Anti-HSV, HIV Ag, and many more.

• Both naturally-occurring and custom formulated to specific titer

• Bulk or dispensed formats

• Our products are completely traceable, from sourcing through processing to delivery—providing a high level of confidence, quality, and safety

Thank you!

Discovery

Clinical Use

DevelopmentProduction

ValidationCompliance