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The pharma industry is searching for new ways to accommodate more modalities within the same facility. Alf Penfold, cGMP and Regulatory Compliance SME explored the range of options for multiple modalities at the ISPE UK Affiliate Conference recently.

Alf was expanding on a previously published white paper, co-authored by Tom Bannon, Biologics & Advanced Therapies SME, PM Group.

“As an industry we have to accommodate more modalities within the same facility. This can be quite challenging with very little guidance within the industry. Tom and I developed a highly effective process to achieve this. It is now being adopted by other companies using the methodology for multiple clients with positive results,” said Alf.

Advanced Therapy Medicinal Product (ATMP) facilities often require more heightened segregation from conventional pharmaceutical facilities. Alf’s presentation discussed the guiding principles, regulations and industry best practices.

The process created by Tom and Alf can be identified in six segments.

  1. Identifying business needs
  2. Identifying possible modalities
  3. Data gathering
  4. Risk profiling
  5. FMEA risk assessments
  6. Segregation strategy for the future multi-modality facility

“Whilst each facility may be different with a different set of recommendations, the same approach and methodology may be used during early feasibility. Our approach is designed to help understand what modalities may be suitable for a given facility and how those modalities may be accommodated,” concluded Alf.

Looking at how to accommodate multiple modalities in your facility?

About Alf

Alf has more than 30 years’ client experience in the Pharma & Biotech industry working for GSK and Pfizer. He is recognised internationally as a Subject Matter Expert in Serialisation having advised the FDA.  His current role in PM Group is focused on cGMPs & Regulatory Compliance.  Alf is a member of the ISPE Regulatory Quality Harmonisation Committee for Europe, the Middle East and Africa (EMEA).

About Tom

Tom has been working in the pharmaceutical industry for over 15 years. He started out his career with both Pfizer and Takeda. He has spent the last 10 years with PM Group. Tom’s current role is consulting in Biologics & Advanced Therapies. He is active in the ISPE and was one of the co-authors for the ISPE Guide: ATMP – Autologous Cell Therapy.