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Laboratory of Plasma Derivatives Safety and Quality Control Section

Laboratory of Plasma Derivatives Safety and Quality Control Section. Principal Investigator: Mei-ying W. Yu, PhD. Research Projects. Safety and QC Standards Parvovirus B19 (5 studies)

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Laboratory of Plasma Derivatives Safety and Quality Control Section

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  1. Laboratory of Plasma DerivativesSafety and Quality Control Section Principal Investigator: Mei-ying W. Yu, PhD

  2. Research Projects • Safety and QC Standards • Parvovirus B19 (5 studies) • B19 DNA, Anti-B19, Case Report, B19 Infectivity In Vitro, Transfusion-Related Infections Prospectively Studied (TRIPS) • HCV (2 studies) • HCV Nt Abs, Molecular Effect of HCV Core Protein in B cells (Wu) • Anti-HAV, anti-D, Anti-Measles, and Molecular Integrity studies • Nt epitopes for HCV, SARS-CoV, and FIX Inhibitors (Zhang)

  3. Reference Standards Established Through International Collaborations • Global (WHO/CBER/Eur Ph) potency standard for anti-D Immune Globulin products [Vox Sang 2003] • WHO/CBER HAV RNA standards for NAT assays [Vox Sang 2005] • WHO/CBER reference reagents to limit levels of anti-D in immune globulin products [Vox Sang 2005]

  4. Pat-1 VIII-3 Pat-2 Pat-3 Pat-4 Pat-5 VIII-1 VIII-2 VIII-4 Plasma-P WHO-1 CBER-2 CBER-3 WHO-3 WHO-4 CBER-P CBER-1 WHO-2 AB126262 WHO-6 WHO-P NC_000883 AB126271 WHO-5 B19-Au AY582161 B19-Wi AY661660 AY582164 AY582163 AJ717293 AY661663 AY647977 8.7 6 4 2 0 8 Nucleotide Substitutions (x100) Parvovirus B19 Transmission by a High-Purity AHF Product (Case Report: CDC/FDA) • Established a causal relationship between the implicated product (and a high-titer manufacturing pool, 107 geq of B19 DNA/mL) and the recipient. • Defined an infectious dose, 2 x 104 geq of B19 DNA, in a product devoid of anti-B19. • Could have avoided the incident if B19 minipool NAT was performed. [Wu et al, Transfusion 2005]

  5. In Vitro HCV Pseudoparticle Assay Correlates With In Vivo Chimp Data Presence of HCV Nt Abs Sample Anti-HCV V.I. Pseudoparticle Chimp <1 : 20 neg S/D Not protected Control IGIV pos HCIGIV S/D 1 : 320 Protected HCIGIV (HCV RNA+) pos None Not infectious 1 : 320 [Yu et al, PNAS 2004]

  6. Anti-HCV Screening Removed Nt Abs to HCV and Compromised Safety of IGIV Hepatitis Cases IGIV (Not V.I.) Pseudoparticle Non implicated lots made from anti-HCV unscreened plasma in 1988-1990 1:320 0 0 1:320 0 1:320 0 1:320 4 <1: 20 Implicated lots made from anti-HCV screened plasma in 1993 2 <1: 20 <1: 20 60 18 <1: 20 [Yu et al, PNAS 2004]

  7. Future DirectionsSafety and Efficacy of Plasma-Derived Products • Setting up NAT and infectivity assays to detect and quantify emerging viral pathogens (& variants) in plasma-derived products • Selecting, enriching and assessing broadly reactive Nt Abs for HCV, parvovirus B19, HBV, SARS, and HAV • HCV pseudoparticles, phage display libraries, in-vitro cultures • Developing safety and potency standards

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