Technology Transfer in Pharmaceutical Contract Manufacturing
Teamwork a Prime Requisite
Teamwork is essential to the success of a technology transfer on the part of both the prospect and the contract manufacturer (CMO). Procedural glitches can easily occur without that all important comfort zone on behalf of both parties, thus leading to costly and time consuming procedures in rescreening potential suppliers.
If last minute surprises are to be avoided, CMO prospects are reminded of the importance in exercising the following principles:
- Make sure the right teams are in place on both sides of the equation.
- Provide the CMO with all the information that is relevant to the process and related assays by effecting data migration prior to process implementation.
- Teamwork must mirror delegation of responsibilities to Project Managers that are thorough in their respective phases of the project.
- The CMO must also perform on-site verification of the data to assure a successful and reliable exchange of information with the prospect. Essentially, cGMP successful or failed test runs are the benchmark. In addition, information must be shared so that all product specs are covered: tight, constant, reliable communications are inherent in all tech transfers.
- Provide information that is up-to-date and complete. Ensure accessibility to a master document as a base reference to fractionalized distribution of information with a central resource person to assure validity of data provided.
- Don’t hesitate to schedule on-site meetings. They can make or break an eventual successful business relationship.
- Regulatory submissions, development reports, raw data, validation reports, etc., are extremely useful.
- Professional project management will necessarily insist on implementation of proper planning: a plan for assay and process transfers, as well as an overall Project Plan that takes all stages into account. Analytical assays should be transferred and qualified first. If not, serious transfer delays may occur.
- The CMO must analyze any of its in-process samples for cell-based impurities and not rely on the final sample only. If so, in the end analysis, the contract manufacturer may develop what is thought to be a good process, but when the in-process samples were analyzed for the first time, cell-based impurities may be out-of-sync for one or more of the control points.
- Small scale verification is much less costly and a key indicator that overall transfer is on track. Start-up scale models can be used to defend the transferred process following the site transfer. Any process must therefore be adequately confirmed by the CMO at the bench scale prior to scale-up and commercial production.
- Engineering runs should be considered essential. The by-pass of this stage does not necessarily save time and money. In some cases, the prospect may refuse to accept the batch as a cGMP lot because of an excessive number of deviations created by acceptable variances at the ingredient level.
- Active ingredients assay at batch level, different viscosity levels in the tanks, 3 consecutive lot evaluation, process validation batches for consistency, sample testing at each level are all ingredients that make up the writing of protocol, execution and final report by the CMO to the client.
Tech transfer summary
To summarize the essence of site transfer processes from the prospect to the CMO, it is imperative to note that tech transfer is not a random process. Its success is contingent upon detailed and reliable communication, planning, discipline and documentation, executed by results-oriented team players.
- Generate essential site selection criteria
- Assemble an effective technology transfer team, with representatives of relevant functions within each organization
- Implement the use of Project Management tools to ensure on-time and on-budget delivery.
- Create and track all project documents to support effective technology transfer to ensure cGMP compliance
- Integrate the sending and receiving of site quality assurance systems
- Validate master plans and protocols for utility systems, analytical procedures, process equipment and manufacturing processes.