Every Active Pharmaceutical Ingredient (API) development project is bound to encounter an unforeseen obstacle that has the potential of impacting the project’s cost or timeline. The likelihood of this happening and the degree of the disruption can both be significantly reduced if there has been a successful transfer of technology from the source client.
This article provides an overview of the project management activities, particularly tech transfer, that contract manufacturing organizations (CMOs) and sponsors can undertake to minimize downtime, disruption and delays that can be costly.
The Importance of Tech Transfer
A well-developed tech transfer package provides a clear understanding of what is known about a process to be developed, and determines the path that needs to be taken to meet the goals of the project. Once these items are understood, project management can focus on which tasks need to be addressed and what level of resources need to be allocated to these tasks, so that the goals of the project can be achieved.
Whether a process is being transferred from an external client or from an internal R&D group to the manufacturing group, the information in the tech package needs to be evaluated by a project team consisting of subject matter experts to determine the completeness of the information.
The goal in scale up is to bring a process into a manufacturing environment that is capable of consistently and cost effectively producing material of the desired quality. Therefore, once the data package is evaluated, the project team needs to:
- Work to determine if additional information is needed to ensure project success.
- Make sure the chemical process to be used is well understood and that the critical process parameters are identified.
- Identify ways to mitigate the risks inherent in scale up by thoroughly understanding critical process parameters and then using this understanding to ensure the process remains within these parameters as the process is scaled up.
- Develop the analytical methods needed to monitor a chemical process during its development and subsequent scale up.
The Importance of Analytical Methods
During process development activities, analytical methods need to be developed to a point where it is possible to check raw materials and to monitor process intermediates to identify and set the critical process parameters.
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Once methods to monitor a reaction are in place, the focus shifts to methods needed to assess the quality of the material produced. When a successful plant campaign ends, the equipment used will typically have to be cleaned so that another process can be introduced. These “clean-out” methods are needed to verify that chemical residues related to the previous process have been removed, eliminating the potential of contamination from previously used materials
What to Do If There’s a Problem: Keep Communicating
If either of these components of the tech package are underdeveloped, project management needs to recognize this and direct resources appropriately to rectify the situation.
When doing so, project management keeps an eye on costs, timelines and deviations make sure to communicate that to the client, and take the following steps:
- Establish open lines of communication between internal project team members as well as with the client.
- Make sure internal members of a project team communicate with each other on a regular basis to identify and resolve issues before they can have an impact on a project.
- Regularly update the client on the progress of project so that there aren’t any surprises during a project.
- Conduct weekly project team meetings for both internal and external project teams help facilitate open communication between a CMO project team and its client.
The success of an API development program is dependent upon a project team’s understanding of the quality of the information contained in the technology transfer package. A well-developed tech package will enable a project to be transferred with a minimum of setbacks.
To enable this process to work most efficiently, the project management team needs to ensure there are open lines of communication among all parties involved in a process transfer. Project team members need to freely discuss technical matters to identify and resolve technical issues before they impact a project’s timeline and budget, and clients need to be kept in the loop so there are no surprises. With a documented, well developed technology package, CMOs can greatly reduce the likelihood of encountering issues during scale up.