The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Feb. 12-14, 2007
Who Should Attend This course is designed for all 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, Regulatory Affairs, Manufacturing, Process Development and Analytical Development staff, and anyone involved with the pharmaceutical industry. Learning Objectives At the end of the 3 day course you will … • understand the importance and underlying principles for the 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 these products through clinical development and into commercialization
• have the tools to understand how to handle biosafety, potency and impurity profile issues for biologic and biopharmaceutical products; and how to set appropriate and meaningful product specifications and expiration dates
• manage manufacturing process changes and establish effective inter-company quality agreements with contractors and suppliers 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 an effective QA/QC strategy to manage the risks at 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, 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. Furthermore, unlike many chemically-synthesized drug products, the manufacturing process impacts 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 the products.
________________________________________
COURSE AGENDA
DAY ONE Unique QA/QC Challenges Presented by Biologics/Biopharmaceuticals • What is a ‘biologic’ and a ‘biopharmaceutical’, and how do they differ from ‘drugs’?
• What unique quality challenges do these products present?
• Are these products treated differently by regulatory agencies? Roles and Responsibilities of QA/QC in Biological Manufacturing & Control • Where and when do GMPs begin for a biologic/biopharmaceutical product?
• Extra GMPs for biologic/biopharmaceutical products
• Cost of QA/QC non-compliance and responsibility of senior management
• Metrics to correct the QA/QC ‘inferiority complex’ in a biologic/biopharmaceutical company BioSafety Controls in a Biological Manufacturing Process • Characterization of source material/cell bank
• Mycoplasma and microbial control during expression and purification
• Viral control during expression and purification DAY TWO Developing the Overall Quality Strategy to Manage Limited QA/QC Resources From Start of Clinical Development Into Commercialization? • Establishing a ‘minimum quality continuum’
• Test method ‘qualification’ vs. ‘verification’ vs. ‘validation’
• Determining appropriate release testing and setting product specifications
• Establishing product stability programs and setting expiration dates
• Managing manufacturing process changes and demonstrating product comparability
• Establishing inter-company quality agreements Potency for Biologics/Biopharmaceuticals • Why is potency so important to these products?
• Regulatory requirements, from Phase 1 through commercialization
• Practical approaches to testing and validating DAY THREE Impurity Profiles for Biologics/Biopharmaceuticals • Sources of process- and product-related impurities
• Handling host cell proteins, residual DNA and endotoxin
• Process validation vs. end product testing What are the Pressures on Biologic/Biopharmaceutical QA/QC Today? • Current concerns that the FDA has with QA/QC carrying out its responsibilities at biologic and biopharmaceutical companies – a review of EIRs, 483s and Warning Letters
• Role of QA/QC in minimizing bio product counterfeiting concerns
|