Customer Credentials – fast and knowledge-based development
Situation at first contact
An innovative biotechnology company without its own galenic development department contacted us to get help in formulating a new API into tablets. They had bad experiences with another CDMO, which was not able to find a robust formulation based on wet granulation even though the drug load was only intended to be less than 20%. In addition, a large part of the existing API has already been used. As further clinical trials were planned, the timetable was at risk.
Our Approach
Step 1 – Analyzing the challenge and defining requirements
The conversation revealed that the company was not committed to a special manufacturing process. In addition, the final dosages had not yet been determined. After introducing the possible manufacturing processes with their pros and cons, we agreed to characterize the API before deciding on the further development strategy.
Step 2 – Characterizing the tableting behavior of the API
By using a compaction simulator, we found out that the API had excellent compaction properties. This enabled us to propose both dry granulation as production method and an increase of the drug load to 40%. The latter left enough room to react to dose changes or changes in API properties during scale-up.
Step 3 – Formulation development
By applying the small-scale development strategy in our lab, we were able to finalize the formulation within 8 month focusing on recompaction and dissolution. During this phase, we worked closely with the client, i.e., all results were summarized in a comprehensible manner, recommendations were given, and decisions on the next steps were made jointly.
Results
After a technical batch was produced at a CMO with our advisory support, the tablets for the clinical trials could be manufactured in time.
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