August 1, 2013
Technology transfer (TT), the transfer of technical know-how from a product sponsor company to a contract development and manufacturing organization (CDMO), is the cornerstone of a fruitful working relationship between the parties. It is critical for successful advancement of the sponsor’s product development and commercialization efforts. Having worked with more than 100 clients over 14 years, PCT has performed nearly as many TT programs, underscored by the key success factors listed below.
Communication: Upon establishing a collaborative sponsor– CDMO staff “team,” it is crucial to identify which communication and project management models work best for the relationship, to agree on frequency and nature of communication, and to establish the most effective communication resources, information exchange platforms, and progress/decision tracking mechanisms.
Clear Expectations: A program charter should be developed to clearly define the overall goals, deliverables, success/acceptance criteria, timelines, critical go/no-go points, and known risks and considerations — as well as to identify roles and responsibilities of each team member.
Technical Understanding: The team should review all available scientific and technical data and documentation (development reports, SOPs, material and equipment specifications, and logistics and clinical considerations) and understand biological material and final product variability, process consistency and robustness, and failure rates.
Practical Understanding: Hands-on training performed by the sponsor staff allows the CDMO to capture those practices, experience, and “art” not included in SOPs, while also providing an opportunity for the CDMO to audit the process before TT. Follow-up training at the CDMO facility allows the sponsor to observe CDMO staff, provide additional technical feedback, and build trust/comfort with CDMO’s technical proficiency.
Alignment: It is crucial for a sponsor to understand that CDMO facility and operations do not need to be a literal replica of its own. Instead, the team should ensure that the CDMO facility, material flow, and environmental controls meet set process requirements, that equipment meets process-specific specifications, that QC testing and analytical procedures meet established product and assay parameters, and that quality systems provide needed controls for implementation.
Change: The team should perform risk assessment–based analysis to delineate between major and minor process changes. Major changes should be addressed through a structured process development program; minor changes can be incorporated ahead of implementation. Any changes should be captured in updated versions of relevant documentation and procedures, and staff should be retrained on the updated documentation and procedures.
Preparation: The team should also perform a phase-appropriate assessment of the level of qualification/validation of the cleanroom (CER), equipment, ancillary and manufacturing procedures, and analytical methods suitable for implementation. This assessment should account for regulatory requirements while focusing on the practical concerns in the context of the process being transferred (risk assessment).
Dress Rehearsal: To provide additional risk mitigation, engineering runs should be performed in which a transferred (and adjusted/updated) process is tested in the CER environment before process qualification (PQ), validation, and implementation. This practice also provides an opportunity to begin establishing comparability to sponsor-manufactured product and process.
Implementation: Develop and execute PQ/validation protocols with clearly defined expectations and acceptance criteria, with the appropriate number of PQ/validation runs. All data should be captured, analyzed, and summarized in a report, including comparability based on prospectively set criteria, media fill validations of process and personnel based on phase-appropriate risk assessment, and shipping validation using PQ material.
However, the greatest challenge of TT is not technical, but rather that of maintaining a productive relationship between the sponsor and the CDMO. It is paramount to be proactive and work as one team to communicate and take ownership of individual roles and accountability. Only then will TT result in an effective and streamlined implementation of the technology to support all future manufacturing and development efforts.
About the Author
Author Details
Sanjin Zvonic, PhD, is director of technology and business development at Progenitor Cell Therapy (PCT); 1-650-934-8541 or 1-201-677-CELL; [email protected], www.pctcelltherapy.com.
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