This workshop will explore two essential aspects of biomanufacturing: CMC (Chemistry, Manufacturing, and Controls) and GMP (Good Manufacturing Practice). These concepts are crucial for the development and production of biologics and ATMPs (Advanced Therapy Medicinal Products). Compliance with GMP regulations is essential to guarantee the safety, efficacy, and quality of biologics and ATMPs. It helps minimize risks, prevent contamination, and ensure batch-to-batch consistency. GMP guidelines are enforced by regulatory authorities such as the FDA (Food and Drug Administration) in the United States, the EMA (European Medicines Agency) in Europe, and other relevant agencies worldwide. Throughout this workshop, we will delve deeper into CMC and GMP principles, discuss case studies, and explore the latest advancements in biomanufacturing for biologics and ATMPs. We hope this knowledge will empower you to contribute effectively to the field and advance the development of innovative therapies.
About the Trainers
Trainer 1: James Drinkwater has been Chairman of the PHSS for 10 years and has honorary membership but recently (during the pandemic years) has taken a more scientific/ technical role as the majority of education has gone online and needs a different ‘marketing/ IT’ skill set to lead the society. The PHSS was one of the EC-appointed commenting platforms in the targeted consultation on Annex 1 revision for the manufacture of sterile medicinal products (that also applies to ATMPs). The PHSS has a strong connection to regulatory authorities, primarily the MHRA UK but also with FDA USA, French, German, Italian, and Danish authorities. It is the Not-for-profit Educational basis that brings this connection.
Currently in the PHSS as a management team member, he has the following lead roles:
• Head of Aseptic processing and Biocontamination special interest group.
• Co-Lead of EU GMP Annex 1 revision focus group
• Co-Lead of focus group preparing guidance on CCS: Contamination control strategies.
Trainer 2: David Murray is as a Subject Matter Expert on the CMC of Biological Medicinal Products and Regulatory Affairs and his role at Parexel involves guiding and advising clients on these aspects at the pre- and post-authorization stages of Clinical Trial and Marketing Authorization procedures.
Prior to joining Parexel in 2021, David worked for 6 years as a Pharmaceutical (CMC/Quality) Assessor of Biological Medicinal Products at the Health Products Regulatory Authority (HPRA) in Ireland. This involved the evaluation of CMC for human biological medicinal products for national and EU procedures. David was a quality assessor as Rapporteur / Co-Rapporteur on new EMA centralized marketing applications and post-authorization variations as well as a coordinator on EMA scientific advice procedures related to the quality aspects for various types of biological products. David frequently delivers lectures to students (University of Copenhagen, University College Cork, Trinity College Dublin, Royal College of Surgeons Ireland) and at conferences as an invited speaker. Prior to joining the HRPA, David developed a strong biomedical research career authoring / co-authoring 40 scientific publications covering a range of biomedical areas including tumour cell biology.
Key Topics
PART 1: AN INTRODUCTION TO CMC
PART 2: (BIO)CHEMISTRY
PART 3: MANUFACTURING
PART 4: CONTROL
PART 5: INTRODUCTION TO THE PARADIGM SHIFT IN GMP
PART 6: CONTROL STRATEGIES
PART 7: PROCESS RISK MANAGEMENT
PART 8: PRINCIPLE GMP CONTAMINATION OF CONTROL MEASURES AND MONITORING
PART 9: FILL AND FINISH OF BIOLOGICAL PRODUCTS AND ATMPS
