Virus Safety in Plasma- Derived Therapeutics: A Merck Perspective. IPFA Yogyakarta, March Louis Wong
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1 Virus Safety in Plasma- Derived Therapeutics: A Merck Perspective IPFA Yogyakarta, March 2017 Louis Wong Associate director, Plasma Initiative, Asia-Pacific
2 Content Regulatory Expectations for Plasma-Derived Therapeutics Multi-Layer Strategy for Virus Safety Prevention - Raw Materials and Chemicals Removal Clearance Technologies Detect In-Process and Final Product Testing BioReliance Testing Services 2 Title of Presentation DD.MM.YYYY
3 Virus Contamination in Plasma A Reality Plasma Product Contamination 1980s: HIV contaminated Coagulation Factor 1994: Hepatitis C contaminated IgG 1995: vcjd contamination Other threats more recently Hepatitis E, West Nile Virus, Ebola, Zika 3
4 Virus Safety in Plasma : Part of a Total Risk Mitigation Program Regular, qualified donors Donation control (serological and NAT tests) Inventory Hold, look back procedure Serological and NAT Tests on plasma pool cgmp Pathogen inactivation/removal steps Batch Release Post-marketing surveillance, pharmacovigilance 4
5 Regulatory Expectations for human plasma Protein products
6 Regulatory Expectations for Human Plasma Protein Products Guideline on plasma-derived medicinal products. EMA/CHMP/BWP/706271/2010 (2011) Incorporate at least 2 orthogonal, effective virus inactivation/removal steps with at least 4 log virus reduction in each step is desirable Virus Inactivation methods/virus removing filters Virus Group Choices Types Details Enveloped Viruses HIV 1 Model for Hepatitis C Pestivirus BVDV could be considered a worst-case for HCV. Enveloped DNA Viruses Non-enveloped Viruses Model viruses for virus reduction filtration (nanofiltration) Herpes Virus Hepatitis B (duck model) Hepatitis A B19V HIV BVDV A validation study should be performed with an appropriate enveloped DNA virus, e.g. a herpesvirus such as pseudorabies. HAV and B19V should be used for validation studies for coagulation factors (History of transmission). For small pore size filters designed for removal of small non-enveloped viruses, HIV and BVDV should still be part of the virus panel, but robustness studies may focus on small non enveloped viruses. For medium pore size filters, BVDV is appropriate for robustness studies. 6
7 Virus inactivation/removal capacity Points to consider for specific product classes EMA/CHMP/BWP/706271/2010 (2011) / Section 8.3 Product Class Coagulation Factors Immunoglobulins Albumin S/D Plasma Details Non-enveloped viruses such as hepatitis A and B19V have been transmitted by this class of products. For Factor IX products, steps should be included in the process that are effective for HAV and B19V. Immunoglobulin products have a good safety record for the known non-enveloped viruses due in part to the contribution from neutralising antibodies in the product. Albumin manufactured by an established fractionation process that includes the terminal pasteurisation specified in the European Pharmacopoeia monograph, has an excellent virus safety record. SD plasma has good safety measures for enveloped viruses and safety measures are in place for HAV and B19 (Ph. Eur. monograph Human Plasma (Pooled and Treated for Virus Inactivation). 7
8 Manufacturing Process Validation Activities by Drug Development Phase Process Validation Activities Perform Preliminary Clearance of Process Impurities Clinical Phases Supporting Activities ---- Initiate Process and Assay Development Initiate Preliminary Process Characterization Establish Preliminary Reference Standard ---- Initiate Clinical Manufacturing Initiate Virus Clearance Studies Initiate Stability Studies 1 Submit IND Application Initiate Manufacturing Process Characterization ---- Studies (test limits) Approve Manufacturing Process Validation Plan ---- Develop/Approve Process Validation Protocols ---- Conduct Additional Virus Clearance Studies 2 Conduct Continuing Process & Assay Development Qualify or Validate Assays ---- Establish Gene Therapy Product Characterization ---- Establish Manufacturing Process Definition ---- Conduct Pivotal Clinical Trails 8
9 Virus Safety: Multi-Layer Strategy A Merck Perspective Virus Safety of Raw Materials Testing of In-Process and Final Product Virus Clearance Technologies 9
10 Overcoming challenges to transition your raw materials Start with the end in mind Quality standards differ for raw materials Quality requirements increase for drugs approaching commercial launch 10 Overcoming challenges to transition your raw materials from Research to Clinical & Commercial 03 February 2017
11 Overcoming challenges to transition your raw materials Comparison of approaches Traditional development Focus on end product safety and performance Fixed process do not change make any changes after Research Fixed specifications Work with suppliers starting phase II Enhanced development Systematic understand material features and process to meet critical to quality attributes Supply Chain Risk Management to ensure uninterrupted drug supply Work with suppliers who can support you in transitioning to Clinical and comply with Regulatory requirements
12 The Merck EMPROVE Concept The EMPROVE concept brings a package of benefits to the plasma fractionation customer that include: Strong process safety and reliability High quality raw materials with GMP production; Strong regulatory support EMPROVE dossier in CTD format allows the customer to save time and money; Full and permanent access to main documents in our website; Top level Quality Control procedures, covering the manufacturing and the supply chain steps. Quality, Safety and Stability are the key words in the EMPROVE brand products for blood plasma fractionation 12
13 General Fractionation Process Steps with EMPROVE Chemicals Multiple steps Multiple steps Cryoprecipitation Stabilizers EMPROVE exp Glycine Sodium Chloride Precipitation Precipitation EMPROVE exp PEG4000 Sodium Capylate Centrifugation/ Depth Filtration Dissolution of Fraction II/III paste Buffers Acetates/Phosphates Sodium Hydroxide SD Inactivation /Low ph SD/Low ph EMPROVE exp TnBP, Triton X-100, Tween 80 Acetic Acid, Sodium acetate trihydrate, Caprylic Acid Lyophilisati on Filling Final filtration Formulation Nanofiltration Concentration/ Diafiltration Liquid Fill Bulking Agents/Stabilizers EMPROVE exp Sucrose, Sorbitol, Maltose, L-Alanine, Glycin N-Acetyl-DL-tryptophan Anion Exchange Chromatography 13
14 Virus Safety: A Multi-Layer Strategy Virus Safety of Raw Materials Testing of In-Process and Final Product Virus Clearance Technologies 14
15 Types of Process Steps ` EMA/CHMP/BWP/706271/2010 Guideline on plasma-derived medicinal products For all plasma-derived medicinal products, it is an objective to incorporate effective steps for inactivation/removal of a wide range of viruses of different physico-chemical characteristics. Inactivation Heat Treatment - Pasteurization (60 C, 10 hours, Albumin) - Lyophilization / dry heat Solvent/Detergent (TnBP, Triton X-100, Tween 80) Low/High ph (Caprylic acid, Acetic acid) - Column Elution/Sanitization Partitioning Precipitation - EtOH - PEG - Caprylic Acid Chromatography - Ion Exchange - Affinity - Gel Filtration NanoFiltration 15
16 Viral Reduction Capacities by Contributive Steps 16 Source: Production of ClairYg, Christophe Segard, LFB
17 Solvent/Detergent Viral Inactivation using Single-Use Technology Objectives: Quantify Impact of S/D Treatment on Chemical Compatibility, Extractables/Leachables and Mixing Efficiency in Single-Use Bags Determine Efficacy of S/D Viral Inactivation in Single-Use Bags Investigate Impact on Protein Activity Create Best Practices for performing S/D Process Step in Single-Use Mixers 17
18 Outcomes of Study Virus Reduction on Human IgG performed in Mobius SU bags Mixing Efficiency in Mobius SU-Mixer 50L and 500L 18
19 Virus Removal by Nanofiltration Virus Filtration performed on 10 different Grifols plasma proteins/products Conclusion of Nanofiltration being extremely effective step in virus reduction Minimal influence of process parameters like ph, temperature, Conductivity, during NF 19 Source: Robustness of Nanofiltration for increasing the viral safety margin of biological products S Caballero et all, Grifols 2014
20 Virus Clearance Validation Virus Safety of Raw Materials Testing of In-Process and Final Product Virus Clearance Technologies 20
21 BioReliance Clearance Services Perform studies at 2 separate facilities Dedicated facilities in both Rockville (MD), USA and Stirling, Scotland. Rockville facility has 4 study suites and a BSL-3 lab. Stirling facility has 5 study suites and a BSL-3 lab. Both make use of state-of-the-art equipment Endpoint testing conducted in adjacent virus titration labs to increase the speed and efficiency of sample analysis. Trained and experienced personnel provide technical and regulatory support for all projects. Besides Viral Clearance and TSE Clearance studies, Mycoplasma, DNA and Bacterial Clearance studies can also be performed. 21
22 Viral Clearance Study Design 22
23 Viral Clearance Studies When are they performed? Stage of clinical trial & indication New process design Cleaning validation Clearance Process changes Updating safety data on licensed products Regulatory changes 23
24 Viral Clearance Studies Testing each process step Spike virus into process intermediate. Must be appropriate to Load material (e.g., liquid vs. solid) Input Virus Cleared Virus Perform scaled-down chromatography process step(s) Perform scaled-down filtration process step Solvent, Detergent, ph inactivation Leftover Virus Collect fractions (e.g., flowthrough, eluate, regenerate) Collect fractions Titrate for virus infectivity level (TCID50)* Reduction = [virus] load [virus] product 24 *qpcr for some removal steps
25 Viral Clearance Studies Generic Study Planning timelines Study Type Early Stage Clearance Study Timelines Design /SOW Pre Study Spiking Study Assays Draft report Final Report Total: Weeks Late Stage Clearance Study Timelines Design /SOW Pre Study Spiking Study Assays Draft report Final Report Total: Weeks Performing a viral clearance study 25
26 Conclusion Three-Pillar Approach for Total Virus Safety Considerations in Plasma Start with the end in mind Merck Key Competencies in Plasma: Regulatory Experts, Virus Clearance Team, Process Validation Experience, Plasma Fractionation Process Knowledge and Leading Technologies 26
27 Thank You! Contact:
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