Seminar 4.1 - Diary by William Chin
Freiburg, Jan 27, 2014 - What is actually necessary from a CMC regulatory compliance perspective to be successful in getting a biopharmaceutical into the market without impacting patient safety? Well, that was basically the theme of EUCRAF’s Seminar 4.1. Entitled “Pharmaceutical Development of Biopharmaceutical and Particulars of the CMC Dossier”, the 4-days seminar kicked off on the 21th January 2014 at the Konzerthaus Freiburg with a total of 24 participants.
Aside from familiar faces, we have a couple of newcomers who joined the full Masters program. The course leaders for this seminar were Dr. Mairead Duke, Regulatory Consultant from Epee Services and Dr. Beatrix Metzner, Head of Global Regulatory CMC Strategy Biosimilars at Boehringer Ingelheim. Both Dr. Duke and Dr. Metzner were very knowledgeable in presenting their material, as they were able to provide real life examples to support discussion. Among the distinguished panel of lecturers present were Dr. Michael Ausborn, Global Head Formulation Research at F.Hoffmann-La Roche; Dr. Jörg Engelbergs from Paul-Ehrlich-Institut; Dr. Fiona Greer, Global Director for Biopharma Services Development, SGS M-Scan; Dr. Hans-Joachim Wallny from Novartis; Dr. Hannelore Willkommen, Regulatory Affairs and Biological Safety Consulting and Dr. Paul Lucas from Amgen. One key element in the career of a regulatory affair professional is the familiarity with the preparation of the chemistry, manufacturing and controls (CMC) section for both the drug substance and drug product. Coming from a NCE (new chemical entities) formulation development background, I could appreciate the lectures that focus on the spectrum of CMC activities for biopharmaceuticals. There are similarities that I could draw parallel to the CMC activities of NCE, but there are also unique requirements for specific biologic manufacturing processes as well as for specific biologic products. This seminar has provided me a thorough understanding of the requirements for the Quality section of Module 3 of the Common Technical Document (CTD). Detailed information and discussions related to pharmaceutical development and analytical characterization of biopharmaceuticals, virus and TSE-safety of biopharmaceuticals, bioassays as well as CMC particular on Antibody Drug Conjugate were provided. Although the preparation of Module 3 may seem like a formulaic writing, with each section clearly defined in the CTD template, it certainly requires more than just linguistic skills. Subject matter knowledge as well as ability to incorporate information from a spectrum of regulatory guidelines is needed to prepare each document in conformance with legal requirements. I am looking forward to the next seminar on the topic of non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements.
William Chin is currently undertaking Master’s in Regulatory Affairs for Biopharmaceuticals at EUCRAF and previously obtained a Ph.D. in Biomedical Science from the Department of Pharmacy, National University of Singapore.