Process Validation in Biotechnology Manufacturing

BTEC Instructor:John Sheppard, Ph.D.
ISPE Instructor: Mark Witcher, Ph.D.

12-14 May 2008
Intermediate Course - ISPE CEUs 1.8

Validation for the biotechnology industry is substantially different from that of traditional pharmaceutical manufacturing, because of the complexity and inherent uncertainty of using living organisms as production systems to manufacture complex, biologically active proteins. Uncontrolled and untested changes in the manufacturing process, including both known and unknown raw materials, can impact the activity and antigenicity of the protein by inducing subtle changes in its structure or conformation. Therefore, controlling the manufacturing process using well-defined operating parameters and raw materials is critical to assuring the safety, potency and consistency of the product.

Process validation provides a critical mechanism for understanding and controlling these vital manufacturing parameters. This course provides an overview of the validation effort as applied to clinical and commercial biotechnology manufacturing. The BTEC facility will serve as a “working example” of how these concepts are implemented.

Course topics include: validation of buffer/media preparation systems; upstream processes such as fermentation and cell culture, and downstream processes such as filtration and chromatography; master plan development and execution; cleaning validation and analytical methods requirements; protocol writing and execution; and handling deviations.

Hands-on sessions in the BTEC facility provide experience in: qualification of upstream bioprocessing equipment such as bioreactors; identifying critical process parameters such as pH, temperature and PO2 control; and validation of specific aspects of a bioprocess, such as CIP, SIP and utilities.

Take Back to Your Job

  • Define key validation activities for biotechnology pharmaceutical manufacturing
  • Develop and execute validation
    master plans and validation protocols 
  • Discuss validation documentation requirements 
  • Apply strategies and fundamental components of cleaning validation, media and buffer preparation validation, and process validation for upstream and downstream clinical and commercial manufacturing processes 
  • Understand requirements for analytical methods used for validation
  • Describe how deviations are handled

Attendance Suggested For

  • Process development engineers, validation personnel, manufacturing supervisors and managers, quality assurance specialists, and management personnel 
  •  Other professionals with commissioning, qualification, and validation experience who need a fundamental understanding of process validation for biotechnology manufacturing

Schedule

Monday

  • 8.30 - 10.00 Course Introduction/Defining Validation/PV Activities: Witcher
  • 10.30 - 12.00 Manufacturing Sciences/Discussion Process: Witcher
  • 13.30 - 15.00 Bioreactor/Fermenter Validation: Witcher
  • 15.30 - 17.00 Orientation to Pilot-scale Bioreactors (hands-on): Sheppard

Tuesday

  • 8.30 - 10.00 Design of Experiments Screening & RSM: Witcher
  • 10.30 - 12.00 Harvest and Recovery/Viral Clearance: Witcher
  • 13.30 - 15.00 Fermentation Control at Pilot-scale (hands-on): Sheppard
  • 15.30 - 17.00 Pilot-scale Data Collection and Analysis (hands-on): Sheppard

Wednesday

  • 8.30 - 10.00 Purification: Witcher
  • 10.30 - 12.00 Chromatography Example: Witcher
  • 13.30 - 15.00 Data Collection for Downstream Processes (hands-on): Sheppard
  • 15.30 - 17.00 Conformance Lots/Operation/Conclusion: Witcher