Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to be adequate and appropriate for commercial production, causing product approval delays and rejections.
Why should you attend: 'Secret', according to Merriam-Webster's dictionary, is 'something kept hidden or unexplained.' A variety of reasons why an effective Chemistry Manufacturing & Controls (CMC) regulatory strategy for biopharmaceuticals can be a secret: (1) job security, especially for regulatory affairs personnel and project managers who master the strategy; (2) the infamous proprietary defense, divulging this strategy only to those within one’s own company or group, i.e., the initiated; and (3) not being aware that an effective strategy can be at hand. Insight and practical suggestions into a common sense business approach to develop and manage an effective CMC regulatory strategy for biopharmaceuticals will be provided in a multi-part series. Part 1 discusses the critical importance of the cell banks for biopharmaceuticals.
Areas Covered in the Session:
* Regulatory definition of biopharmaceutical starting material
* Common cell lines chosen for biopharmaceutical production
* Issue of clonality
* Clinical phase-dependent regulatory requirements of recombinant cell banks
* Pros/cons of changing cell banks during clinical development
* Issue of inadequate documentation for preparation of the master cell bank
* Critical importance of an effective CMC strategy for cell banks - lessons learned from product approval delays and rejections
Who will benefit:This course is designed for managers, supervisors, project planners and professional staff who develop or implement the Chemistry, Manufacturing & Controls (CMC) regulatory strategy for biopharmaceutical products.
* Project Management
* Regulatory Affairs
* Quality Assurance
* Quality Control
* Process Development
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