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.
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.
Who Should Attend?
This webinar will benefit high-level professionals from start-up biotech companies developing biopharmaceuticals. Those working within biotech or pharmaceutical companies planning contract manufacturing operations of biopharmaceutical clinical trial materials for the first time or seeking to improve their technology transfer practices will also find this presentation to be relevant.
What You Will Learn
The following will be discussed:
- Essential elements for the successful technology transfer of biologics manufacturing processes
- An effective communication plan for smooth interactions
- The information necessary to define a biologics manufacturing process and assist in its further development
- Risk management
- Criteria to determine whether a transfer has been successful
Abzena is a leading contract provider of integrated discovery, development and manufacturing services for biologics and antibody drug conjugates (ADCs). Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and bioconjugation drug development and manufacturing in the biopharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors. For more information, please see www.abzena.com.