02.17.21 -- Problem-Solving Essentials For Drug Formulation And Manufacturing

Developing and manufacturing complex parenteral drugs requires a solid foundation of skill, quality, and risk management. When adding in the complexities of a highly potent compound, an aseptic environment, small amounts of API, or a combination product of a drug in a medical device, risks increase and so does the need for even greater levels of skill and knowledge to ensure success.

As COVID-19 vaccine development and manufacturing has rightfully become a global priority, it has left other vaccine producers and public health organizations searching for manufacturing capacity. Facilities committed to COVID-19 production are forcing non-COVID-19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case.

Pharmaceutical technology transfer often invokes images of a complicated set of activities required to transfer the development and manufacturing of a product, or products, from one facility to another. This article shares five features of a successful tech transfer — imperatives with a focus on drug sponsors working with CDMOs that, when applied to project management operations, can deliver extraordinary results.

Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems pharmaceutical scientists and engineers face and can lead to the most interesting, innovative solutions. Effectively employing the three problem-solving essentials — experience, reasoning, and creativity — can be the catalyst for success.

Bryan Braxton has a friendly, grounded demeanor and a scientific mind that creates solutions for our most complex aseptic development projects. But how did these two traits combine in the same person?