Clinical, R &D, Regulatory Support

Analytical Methods Development

SeraCare scientists have been meeting our customers' needs for bacterial or viral assay development and validation since 1973 using:

• Capture plate NA detection
• Drug susceptibility testing
• ELISA protein/Ab detection
• Neutralization testing
• Northern, Southern, Western blots
• PCR, TaqMan, and SDA
• TCID₅₀ measurement
• Viability determination
• Virus quantitation
• Cell sorting

Custom Prospective Collections

The SeraCare network of disciplined sites delivers reliable and efficient custom collections from concept through study design to ultimate delivery of clinical specimens and data. We pay careful attention to ethical guidelines, HIPAA, and informed consent, and our experienced MD, PhD and nursing staff will provide guidance to achieve your objectives in the most efficient manner. Our Clinical Team will deliver:

• High-value multigenic disease states; client-directed disease-based collections
• CRF design and management
• Sample integrity and quality-control
• Objective inclusion criteria and independent pathologist confirmation of diagnosis
• Custom specimen collection kits

Collections of : Whole Blood, Serum, Plasma, Tissue, DNA & RNA

Nucleic Acid Technology

Isolation and Characterization

SeraCare annually performs tens-of-thousands of isolations. Our DNA extraction capacity exceeds 200 specimens a day, and DNA plating capacity is 3000 + specimens, using:

• Blood, plasma, serum
• Buccal cells
• Clotted/dried blood
• EBV-transformed cells
• Fresh-frozen/paraffin-embedded tissue
• Laser capture cells
• Packed cells
• PBMCs
• Tumor tissue

DNA characterization includes gel electrophoresis and DNA quantitation, purity ratio (A₂₈₀/A₂₆₀), fragment analysis and confirmation that it can be amplified. RNA is characterized by purity ration and 285:185 band ratio.

Amplification, Quantitation, Sequencing and Genotyping

SeraCare clients benefit by access to scientists who have performed 100,000+ genotypes, whole genome amplifications and quantitations. Amplification formats include:

• ABI TaqMan
• B-D SDA
• Roche Amplicor RT-PCR
• Southern blot for DNA amplicons

We routinely quantitate:

• HBV DNA
• HCV RNA
• HIV-1 RNA, cDNA
• HPV DNA
• Parvovirus DNA
• West Nile Virus RNA

Nucliec acid sequencing templates utilize human, bacterial and viral sequences. We've performed SNP, STR or gene linkage analyses on hundreds of families and thousands of individuals, and are proficient in genotyping HBV, HCV and HIV.

Our expertise extends to full-length sequencing of screened clones, construction of primary and normalized cDNA libraries and hybridization of non-radioactive cDNA and genomic DNA probes.

Virology/Immunology

Antigens, Antibodies, Nucleic Acids, Custom Products

SeraCare is a world leader in production of HIV-1 subtypes manufactured under cGMP regulations and used in pharmaceutical and diagnostic research. We isolate and analyze a wide range of targets from our Global Repository® of normal and disease state tissue, and perform specialized services using:

• Purified RNA or virus particles from all major HIV-1 subtypes and most key geographic areas
• Anti-HCV IgG from human plasma
• Non-infective HIV-1 from 8E5 line
• EBV-transformation of B-cells

Serological Testing Laboratory

SeraCare experts bring decades of experience to contract services performed at our CLIA-certified, BSL-2 laboratory. Capabilities include:

• HBsAg ad and ay subtyping
• HBV Ag and Ab
• HCV Ag and Ab
• HIV-1 and HIV-2 Ag and Ab
• Lyme Ab
• Parvo B19 Ab
• West Nile Ab

Virus Culturing, Detection and Quantitaion

Virus Cultivation and characterization, as well as verification of virus inactivation by chemical, irradiation, or thermal means, represent other areas of SeraCare s expertise. We are highly experienced in:

• BVDV cultivation
• HIV cultivation
• HIV expansion and characterization
• Porcine Parvovirus culture
• Other viruses

Viral Infectivity and Drug Susceptibility Analysis

SeraCare frequently provides independent, expert analysis of the effectiveness of infectivity of H9 and PBMC samples with HIV. A related service is assessment of the efficacy of candidate compounds against all major HIV-1 subtypes from throughout the world plus drug resistant mutants and HIV-2, under cGMP culture conditions. IC50 determinations are standard, with optional genotyping of resistants.

Biorepositories for High-value Specimens

Facilities

SeraCare manages over 15 million specimens, including cell banks, tissue, sera, plasma, slides and nucleic acids, in facilities encompassing 80,000 square feet. Customers have utilized this service since the late 1970's and rely on our ultra-modern facilities to deliver security and efficiency through:

• Custom specimen identification, tracking and retrieval systems (Genomics Factory^TM LIMS and Biological Specimen Inventory, Ver.2)
• Restricted-access and extensive back-up power and freezers
• 24/7 environmental monitoring systems automatically direct back-up power and notify on-call staff
• Automated, customized Thurnall robotics system
• Storage choices from room temperature to liquid nitrogen

Facilities are FDA regulated and operate under applicable GMP and GLP conditions and CLIA Certification

Capabilities

SeraCare delivers timely, efficient and high-quality analysis and preparation of specimens stored in our Biorepository or sent to us by customers.

Our skills encompass

• Protein and nucleic acid isolation, packaging and shipping
• Cell isolation, cryopreservation and transformation
• Genotyping and SNP analysis
• Whole-blood fractionation
• Viral material analysis

Custom Diagnostic Products & Services

Our diagnostic repertoire includes products for serological or nucleic acid applications. SeraCare will process raw materials into finished goods in our ISO 13485 facility, based on your exact specifications. SeraCare can ship your custom products directly to third parties worldwide.

• Options for human plasma processing include heat or chemical treatment, defibrination, delipidation, addition of preservatives, buffer additions or diafiltration, custom protein adjustments, as well as analyte and hormone shipping.
• Our extensive in-house testing capabilities include general chemistry, bioburden, serology, immunology and autoimmune testing on multiple platforms with different methods.
• Custom Products: Custom controls, standards, calibrators and panels are our specialty. We will provide custom packaging configurations, custom labeling (RUO, IVD, ASR, your logo), randomized or bar-coded identified vials and assembled boxes.