For the first time in two years, a number of Lachman Consultants Team were able to attend the PDA Annual conference in Dallas, Texas this week. At this meeting, there was an opportunity for many of the PDA Interest Groups (IGs) to have face-to-face discussions that had, for the last two years been virtual due to the Covid 19 pandemic. Many of the sessions gave updates on the status of the IGs followed by open discussions that provided some insight into the efforts of the IG. For those who are not familiar with this organization, the IGs are made up of very experienced industry, regulatory, and outside stakeholders that volunteer their, so that our industry can benefit from their collective collaboration through discussion posts on PDA’s online community and the publishing of position papers, articles to the PDA Letter, and Technical Reports (TRs) on a wide range of issues of interest to the pharmaceutical manufacturing and compliance community as a whole.
On Day 2 of the conference, the Vaccine IG presented information on their upcoming Technical Report titled Strategies for Vaccines Development and Lifecycle Management, which was written to provide direction to companies to help address current vaccine manufacturing challenges (obviously a very timely publication!). Jane L. Halpern, Ph.D., Executive Director, IAVI and Sabrina Restrepo, Ph.D., Merck & Co., Inc. together lead the Vaccine Interest Group. Dr. Restrepo provided the IG update on the status of the upcoming and highly anticipated Technical Report.
Some of the main topics discussed in the TR are:
- Control Strategy from Process Development throughout the Vaccine Lifecycle
- Comparability Assessments and use of Comparability Protocols/Post-approval-change-management -protocols (pacmps) in vaccines
- Vaccine Lifecycle Management
To date, the document has gone through review by:
- National Health Authorities
- DCVMN (Developing Countries Vaccine Manufacturer’s Network)
- CEPI (Coalition for Epidemic Preparedness Innovations)
After an exhaustive review, 150 comments are being addressed to ensure that the Technical Report is both robust and provides clear guidance to industry. The IG is planning for a June/July 2022 release of this TR and we all look forward to seeing this. Be sure to stay tuned to this blog for further developments on the Technical Report.