Elements for Smooth Technology Transfers of Biologics Manufacturing Processes

Effective communication, complete and accurate information transfer, risk management, and clear success criteria are essential elements for smooth and effective technology transfers of biologics manufacturing processes. This is true whether the technology transfer is only a protein sequence or involves the transfer of fully developed processes and testing methods. Good communication plans facilitate effective information exchange and enable timely discussion of progress/questions/changes/hurdles that arise during collaborative manufacturing campaigns. They are mutually developed by all parties and identify the individuals involved, along with their contact information, define roles and responsibilities, establish key deliverables and delivery dates, set meeting schedules, and establish guides for ad hoc communication channels.

Accurate information should include, but not be limited to:

• Key information about the product being produced
• The raw materials, consumables, and processes used for its manufacture (if available)
• The analytical testing methods used to assess its identity, strength, quality, and purity
• Formulation development results
• Product and process intermediate stability data

The information is commonly included in a series of reports, including a product description, process description(s), process development report(s), analytical methods descriptions, analytical methods qualification reports, analytical methods validation reports, formulation development reports, and stability reports. Review of the available data allows the participating parties to identify knowledge gaps and to create plans to address them.

Risk management builds robustness and contingencies into the technology transfer process. Identification of potential pitfalls, their probabilities, and the severity of the resultant consequences informs the technology transfer team’s work plans and the proactive scheduling of contingency activities. Finally, establishing clear criteria for a successful transfer, along with the mechanisms to demonstrate their achievement, complete the technology transfer process. This usually includes performance of the transferred processes and analytical methods at one or more scales in a way that meets the agreed criteria. Diligent attention to these essential elements establishes a strong foundation for a successful technology transfer and future collaboration activities.

Speaker

Louise Duffy, Ph.D. SVP & Head of Scientific Project Leaders at Abzena

Louise has an extensive background in the global biopharmaceutical industry with more than 30 years of experience in R&D and commercial supply. Louise specialises in the development, technology transfer, and supply of biopharmaceuticals, vaccines, and cell & gene therapies for global markets. She has in-depth CMC and regulatory experience including the development of strategic CMC plans to support regulatory filings such as INDs, IMPDs, BLA, MAAs.

In her role at Abzena Louise is responsible for providing technical and CMC regulatory leadership and guidance across the Abzena portfolio from early development to commercial production. She is responsible for ensuring scientific input is provided to project teams and works collaboratively with clients for project success. Louise holds a Ph.D. and M.Sc. in chemical engineering and a B.Sc (combined honours) in chemistry and biochemistry.

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