Drug Product Development

Early planning considerations for Drug Product Formulation Development, Process Development and Tech Transfer

Thierry Nguyen, MB, EMTM

1/10/20241 min read

a group of plastic cups sitting on top of a machine
a group of plastic cups sitting on top of a machine

Virtual biotech and/or biopharma companies often underestimate the importance of allocating employee time for drug product development, process development, and technology transfer. Typically, this planning is done after achieving success in drug substance development. However, it is crucial to consider patient-centric design, development, and process execution at an earlier stage, ideally during CMC development, starting from the definition of the Target Product Profile. By doing so, a clear path can be created, and presumptive critical qualities attributes, process parameters, and methods for detecting them can be identified. This early planning also helps in devising a presumptive process control strategy, enabling the CMC team to proactively address, mitigate, or monitor specific attributes and related process parameters. Bodhi Nature LLC is excited to offer support to clients and companies navigating this space without requiring their full-time commitment.