The Center for Professional Innovation & Education, Malvern, PA
06/18/08
Who Should Attend
This course is designed for management and professional staff involved in or interested in quality assurance (QA) and quality control (QC) support for biologics and biopharmaceuticals. This course will be of particular interest and applicability to QA and QC staff and management, Regulatory Affairs, Manufacturing, Process Development and Analytical Development staff, and anyone involved with the biological and biopharmaceutical industry.
Learning Objectives
At the end of the 3 day course you will: - Understand the importance and underlying principles for QA/QC of biologics and biopharmaceuticals, and know how these principles differ from those for chemical-origin drug products
- Develop a cost-effective, risk-managed QA/QC strategy to move products through clinical development and into commercialization, including establishing effective inter-company quality agreements with outsourced contractors
- Have the tools to address biosafety, potency and impurity profile issues for biologic and biopharmaceutical products; and how to set appropriate and meaningful product specifications and expiration dates
Course Description
With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape for biologic and biopharmaceutical products, coupled with ongoing changes in regulatory compliance regulations and expectations, it is most important for a company to have a QA/QC risk management strategy effective for each stage of drug development, from Phase 1 clinical trials through market approval.
While there are considerable similarities between biologics/biopharmaceuticals and chemically-synthesized drug products, many of the QA/QC issues and challenges are different. Biology-based drug products are more complex products derived from potentially changing living sources that are highly susceptible to contamination with adventitious agents such as viruses and transmissible spongiform encephalopathies. Impurities in biologic/biopharmaceutical products raise concern not only of potential toxicity but also tumorigenicity and immunogenicity. Furthermore, unlike many chemically-synthesized drug products, the manufacturing process can impact both the potency and the immunogenicity of the biologic/biopharmaceutical products. This course highlights the challenges and pressures facing QA/QC in today’s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, and testing and release of these products.
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