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.
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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.
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:
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.
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
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:
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.
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