The Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes. More specifically, it applies to process design ties to facility design, controlled processing, preventing contamination, and segregation and flow.

This Guide, produced by task teams of 100-plus regulatory and industry leaders, can be used by pharmaceutical industry for the design, construction, commissioning, and qualification of new facilities for the manufacture of biopharmaceutical Active Pharmaceutical Ingredient (API), also known as drug substance. These facilities must meet current Good Manufacturing Practice (cGMP) regulations and comply with local codes, laws, and regulations • and this Guide helps achieve those goals.

Keeping in step with 21st century innovations, the Guide covers:

• in-line process analytical measurement and control
• the use of disposable equipment
• enhanced strategies for automation
• alternative methods for protecting the integrity of the product

This Guide applies to products and facilities that house biotechnological process (es) as well as processes that use cells or organisms generated or modified by recombinant DNA, hybridoma, or other technology to produce APIs. It helps in manufacturing other proteins and polypeptides isolated from tissues and body fluids. In addition, the Guide applies to facilities dedicated to production of clinical trial materials.

This Guide addresses U.S. GMPs, with the GMPs of other countries and regions covered in the appendices. National Institutes of Health (NIH) requirements and safety issues are included in this Guide where they affect GMPs or design. This Guide does not attempt to cover biopharmaceutical GMPs that do not address the facility or the manufacturing process technology.

The key concepts defined and used as a basis for this Guide include:

• Does the Process Equal Product?
• Process Design is Tied to Facility Design
• Controlled Processing
  • Know the Product (and its process)
  • The Process Should Not Add Contamination
  • Contamination Control Strategy
• Segregation and Flow
  • Primary And Secondary Segregation
  • Flow and Traffic Patterns in the Facility
• Open vs. Closed Processing
• Scale Affects Decisions
• Single Product vs. Multiple Products Manufacture

Related Community of Practice: Biotech