SeraCare Life Sciences provides products and services to support the development, validation, and production of human diagnostics and therapeutics. They offer a portfolio of controls, panels, reagents, and contract services including sample collection and testing. SeraCare has facilities in Massachusetts and Maryland and sources plasma and other raw materials to support customers' research and manufacturing needs.

1. SeraCare Life Sciences
Your Total Solutions Partner

2. 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.

3. Facilities and Locations
SeraCare Life Sciences
Headquarters, Manufacturing
Milford, MA USA
SeraCare Life Sciences
R&D, BioServices, Manufacturing
Gaithersburg, MD USA
SeraCare Life Sciences
BioServices- Repository
Frederick, MD USA

4. SeraCare’s Portfolio of Products and Services
PRODUCTS SERVICES
Controls & Panels Reagents & Bioprocessing Products Clinical Trials & Central
Processing Laboratory
• ACCURUN® and custom controls and • Extensive sample management
• High quality purified biological products
performance panels verify accuracy of capabilities including:
and materials for development and
diagnostic tests manufacture therapeutics, vaccines and Site training, collection kit
diagnostics distribution, storage, data
• Comprehensive portfolio of infectious
disease controls readily available • Readily available plasma-derived analysis
diagnostic intermediates • Contract research in molecular
• Controls developed for low level
positive with targeted assays • Sourcing and Purification of custom biology, virology, immunology
and biochemistry
intermediates
• Extensive Library of viral isolates
• Consultative assay
• Design and Development of development and production
Proficiency Panel components

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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 Technical Services
Stability testing
Product Fill & Packaging
• ISO 8 clean rooms
• Bulk fills
• Lyophilization and dry-down chemistries
• Custom labeling
• Automated vial fills
Custom Manufacturing

14. ACCUTYPE Manufacture and Distribution

15. 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

16. Development
Discovery Production
Compliance
Clinical Use Validation
Thank you!