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CMC Strategy Forum January 2015
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Monday, January 26, 2015

Renaissance Mayflower Hotel, Washington, DC 




Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs and Regulatory Expectations
Forum Co-chairs: Sarah Kennett, CDER, FDA and Andrew Weiskopf, Biogen Idec 

Just as biopharm drug substance and drug product development organizations adhere to practices which ultimately mesh with their companies' commercial quality management systems, the same is now true for those who develop combination products. In this CMC Strategy Forum we will cover both regulatory and practical aspects of developing prefilled syringes, autoinjector pens, pumps and novel drug/device combinations in order to facilitate the transition from clinical development to licensure and beyond. 

Topics will include design controls, design verification and validation, the role of human factors in combination product development strategy, regulatory expectations for combination product reviews and inspections and best practices in early combination product development vs. post-approval and legacy products.

Current Perspectives on Host Cell Protein Analysis and Control: Science, Risks and Regulations
Forum Co-chairs: Dieter Schmalzing, Genentech, a Member of the Roche Group and Zahra Shahrokh, STC Biologics

For thorough understanding, effective removal, and suitable control of host cell proteins (HCPs) in recombinant biotechnology products, state-of-the art analytics are key to properly guide process development and to minimize potential risks to patients such as immunogenic response. 

The one-day Strategy Forum integrates perspectives on the science, product quality/safety, and regulatory aspects of HCPs and their control. Specifically, it aims to provide a critical evaluation of the existing and emerging technologies for characterization, clearance, comparability and control of host cell proteins in biotechnology derived products. Case studies will be presented that exemplify best practices to maximize HCP coverage, the utility of product-specific versus platform methods, and the applications of mass spectrometry to aid in detection and estimation of HCPs that evade immunoassays. In addition, industry and regulatory agency experiences on risks to product quality and manufacturing consistency with potential impact on clinical outcomes will be shared. Current regulatory expectations and pharmacopeia efforts will be presented and discussed. 


To register for this meeting, click here

To visit the CMC Strategy Forum meeting homepage, click here

To register for this meeting, click here

To visit the CMC Strategy Forum meeting homepage, click here

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