Biomanufacturing Training and Education Center (BTEC) s International Influenza Vaccine Manufacturing Training Program

Transcription

1 Biomanufacturing Training and Education Center (BTEC) s International Influenza Vaccine Manufacturing Training Program 5 th Meeting with International Partners on Prospects for Influenza Vaccine Manufacturing Technology Transfer to Developing Country Vaccine Manufacturers Belgrade, March 27-29, 2012 Dr. Ruben G. Carbonell BTEC Director

2 BTEC s unique focus High-quality hands-on experiences Industry-ready workforce training Professional development courses Process development and analytical services Facility highlights North Carolina State University, Raleigh, NC, USA 82,500 ft 2 (7,665 m 2 ) labs, classrooms and offices $15 million(usd) in cgmp equipment 3 scales of operation: bench (2 L), intermediate (30 L) and pilot (300 L) 2

3 BARDA influenza vaccine manufacturing program offerings 2012 Fundamentals of cgmp influenza vaccine manufacturing (2 sessions) Course taught in 2011 Advanced upstream processes for influenza vaccine manufacturing (1 session) New course for 2012! Advanced downstream processes for influenza vaccine manufacturing (1 session) New course for 2012! 3

4 Participants in 2012 program by course (46 places filled, 45 individuals) Country Institution Fundamentals Adv. Upstream Adv. Downstream Egypt Vacsera India Serum Institute Indonesia Biofarma Kazakhstan RIBSP Korea Green Cross Mexico Birmex Romania Cantacuzino Inst Russia IEM Serbia Torlak Institute South Africa Biovac Institute Thailand GPO Vietnam IVAC 2 2 1

5 Fundamentals Course content Modules (Total Hours) Activities and labs (Hours) 1. Introduction (4) Not applicable 2. Regulatory / Quality Systems (12) EMA, FDA, ICH, cgmp Guidelines review (3) 3. Aseptic Practices (8) Contamination mitigation, monitoring, control Evaluation of BTEC practices (2) 4. Facilities and utilities (8) Process flows, HVAC BTEC tour and evaluation (2) 5. Upstream processing (32) Egg- and cell-, single and multi-use technology CIP/SIP, cell banking, growth kinetics (16) 6. Downstream processing (32) Centrifugation, chromatography, UF/DF Monolith vs column chromatography (18) 7. Analytical (24) HCP, DNA, endotoxin, bioburden NA, HA, SRID, SDS-PAGE (14) Course total = 120 hours 5

6 Advanced Upstream Course content Modules (Total Hours) 1. Introduction / influenza virus safety (5) 2. Fundamentals of cell culture (22) Sterility, viability and eukaryotic cell growth 3. Process development and scale-up (25) DoE, range-finding and design space 4. Analytical tools (12) Validation of HA assay 5. Regulatory aspects (6) Cell banks, animal-derived materials, virus seeds, safety and efficacy Course total = 70 hours 6

7 Advanced Downstream Course content Modules (Total Hours) 1. Introduction (2) 2. Low-speed centrifugation (7) Ranges for process and performance 3. Ultracentrifugation (7) Density gradient separation optimization and scale-up 4. Analytical methods (16) Host-cell protein/dna, potency, safety 5. Viral inactivation (8) Review and comparison of industry-standard methods 6. Chromatography (16) Range specification and scale-up 7. Tangential flow filtration (8) Range specification and scale-up 8. Process validation (6) Definitions and challenges Course total = 70 hours 7

8 Assessment tools used in the program Tool Purpose Notes Registration system Course Assessment Tool (CAT) End-ofmodule quizzes End-ofcourse evaluation Follow-up survey Gather participant information Measure overall learning during training Measure participants mastery of content Gather feedback on content, instruction & program logistics Gauge transfer of learning to the workplace Online form connected to database Identical pre-/post-test before & after course Computer-based 2 hours allowed to submit 30 minutes allowed to complete 20 minutes allowed to complete Administered 8 weeks after course ends 8

9 Instructional strategies Direct instruction by subject matter experts Egg- and cell-based production approaches Regulatory issues focus Hands-on laboratory exercises Use of A/CA/7/09-like (H1N1) or model bacteria phage (source: Novartis) 9

10 Instructional strategies (continued) Short seminars from industry experts Tours of local vaccine manufacturing facilities Partnership with Novartis to use their suspension-adapted MDCK influenza cell line Novartis AG 10

11 Other vaccine manufacturing offerings available outside of BARDA program Online training courses Quality and Regulatory Systems for Vaccine Manufacturing Fundamentals, Upstream, Downstream Operations Hybrid training courses Online lectures + on-site hands-on laboratory activities Customized courses Upstream, downstream, analytical, regulatory, facilities Contact us to design special programs to meet specific needs of any DCVM Network participants 11

12 Quality Management Systems Documentation Policy Quality Manual The company s policy regarding Quality Describes the Quality system of an organization Company Standard Global Practice Outlines the minimum regulatory & business requirements for Q system Documents define Who, What, When Standard Operating Procedures (SOP) Describe the How to 12

13 Online course: Quality and Regulatory Systems for Vaccine Manufacturing Module Description Course Introduction and Medical Products Product Life Cycle U.S. Food & Drug Administration (FDA) Other Regulatory Agencies Quality Systems Risk Management Product Design/Process Development Clinical Trials, CTM Manufacturing Facilities Utilities Outsourcing Equipment Life Cycle, Commissioning Facility and Equipment Qualification Process Validation Cleaning Validation 13

14 Online course: Quality and Regulatory Systems for Vaccine Manufacturing (continued) Module Description Components Production Systems, PAT Documentation Training Quality Control, Stability Failure Investigations CAPA, Change Control Batch Release Auditing and Evaluation Regulatory Approvals Board of Health Inspections Post-Marketing Surveillance 14

15 For additional information, contact: Dr. Jennifer Ruiz Dr. Ruben Carbonell For information about BTEC programs, visit: 15

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