The tech transfer planning process should begin with a review of the dosage form’s Critical Quality Attributes (CQAs), equipment train used, excipient functionality, and process. Pii staff consider whether anything technically can be made better, question the drug sponsor’s intentions behind the process, and attempt to mold that process in the similar equipment train at Pii.

In one example, a drug sponsor contracted Pii to handle a tech transfer from a competing CDMO. This was a first-to-market chewable tablet for veterinary use that comes in four strengths. These tablets have a unique shape and high tablet weight, especially for the highest strength. In test production, it was discovered that the highest strength tablet would break and chip during downstream processing. The high weight of the tablets resulted in plastic deformity and relaxation post compression, and the unique shape exacerbated the chipping issue.

In order to meet the sponsor’s launch goals, Pii formulation and MSAT teams proposed a short- and long-term solution. In the short term, instead of one common blend for the four strengths, Pii modified the blend for the higher strength within the SUPAC guidance to reduce the tablet weight and minimize the handling issues. For the long-term solution, Pii recommended round tablets to completely remove the chipping and breaking issues. The launch was on time and successful.

In another example, Pii handled the tech transfer of a liquid formulation for an Orphan New Drug Application (NDA). The liquid formulation drug was already developed at lab scale. After due diligence and creating a framework and tech transfer plan, commercial-scale production was set in motion with a specific equipment train.

During the engineering batch, particles were observed in the solution towards the later part of the filing process. The particles came from the gaskets of the displacement filling pump. The formulation developed was a simple solution of API in mostly water without any other excipients that could lower the friction between the gasket and the walls. This resulted in gasket wear out after a certain period of filling.

Options to change to different filling pumps were available, but involved long lead time and cost. Maintaining the launch time was critical for this product. The formulation and MSAT teams determined the exact failure point of the gasket and decided that the filling be validated with a specific number of bottles whereupon the gasket would be replaced to mitigate the issue. The sponsor was able to launch the product on time.