SeerPharma has identified a growing demand from cell and gene therapy manufacturers across the APAC region for expert advisory services and tailored training in Good Manufacturing Practice (GMP). Recognising this need, our team has expanded its capabilities in this specialised area, culminating in the design, development and delivery of a GMP training program for advanced therapy medicinal products (ATMPs) at the undergraduate level for the Chinese University of Hong Kong. Read more about this collaboration.
Building on this success, SeerPharma has been engaged by a manufacturer in the region to design and deliver a comprehensive one-day training course on TGA and FDA GMP requirements for Phase 1 Clinical Trials. This program is specifically tailored to meet the needs of organisations involved in early-stage product development and references key regulatory guidelines and standards, including:
The training course addresses critical topics such as the pathway to product approval in the US and Australia, the role of Chemistry, Manufacturing and Controls (CMC) in connecting product development with GMP manufacturing, minimum GMP requirements for Phase 1 cell-based products, Quality Assurance (QA) and Quality Control (QC) principles, sterility assurance, qualification and validation requirements, and the key differences between manufacturing allogeneic and autologous products.
Participants in this training will gain a solid understanding of GMP principles and modern Quality Systems, including the regulatory frameworks governing the manufacture of cell-based products in both the USA and Australia. They will learn to identify similarities and differences between these frameworks, evaluate GMP requirements for Phase 1 clinical trials, distinguish between the production of allogeneic and autologous products, outline qualification and validation requirements, and apply QA and QC practices using sterility as an example of a Critical Quality Attribute (CQA).
If you’re an organisation involved in the early-stage development of cell and gene therapies, contact SeerPharma to learn more about this training program and explore the range of advisory services we can provide to support your teams.