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
  
• Manufacturing
  
• Quality Assurance
  
• Quality Control
  
• Process Development