CGMP Preparation for Phase 3 and Commercial Manufacturing
Barry Rosenblatt, Ph.D., President, SME Biotech Consulting; is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotherapeutics with a proven 30+ year track record in biotechnology and the pharmaceutical industry. Developed, transferred and validated purification processes and assays for multiple new molecular entities through all stages of drug development, including licensure. Currently serving as a consultant to the industry as President/sole proprietor of SME Biotech Consulting. The proven presenter who has served as an instructor, presenter, as well as Chairperson for conferences and courses. Previously served as associate director of Process Development for Centocor/JNJ (18 years) and 8 years as head of Analytics, Process Evaluation, Contract Manufacturing, and Sterile Services at Charles River Laboratories, Malvern PA... Academic credentials include a Ph.D. in Cell Biology/Immunology from the Albert Einstein College of Medicine, Bronx, NY.
This session with exploring the elements required for a successful transition from an early phase development organization to a “Commercial ready” manufacturer. It is intended for anyone who may be involved in the oversite and participation in the manufacturing and distribution of a potential commercial product. Upon completion of this session, the attendee will have a greater understanding of the process and what is required to ensure a higher probability of success.
The transition of a project from early phase clinical manufacturing to the pivotal trial (Phase 3) and eventual manufacturing requires a re-assessment of the CGMP status of the manufacturing facility. This gap analysis requires a deep dive into all of the existing systems and planning/implementation of programs to fill those gaps PRIOR to initiation of these phases.
- Determination if the organization is ready
- Gap analysis of systems
- Operating systems
- Materials management
- Quality systems
- QA systems
- IT systems
- Human resources
Course Level - This presentation is at a beginning to intermediate level
Who Should Attend
- Process Development Scientists
- Project Managers
- Manufacturing Scientists/Managers
- Process Engineers
Why Should Attend
During the early phase development of a new molecular entity, the systems supporting the manufacture and analysis of that entity are often also under development. As a result, significant gaps can exist between what is expected for the eventual filing and commercial production.
These systems include
- Operational systems
- Quality Systems
- Human Resources
Gaps in any of these systems can lead to 483 observations, “refusal to file” rejections, and possible production failures.
This presentation will give an overview of the steps needed to examine these systems and provide a guide for planning the required upgrades needed to bring an organization into better compliance.