We’ve put together a series to feature the top minds in formulation development, analytical services, development, quality assurance, and converting.
Meet Tapemark’s Sr Process Engineer, Tim Brown
Tim has been a part of Tapemark’s engineering department for 15+ years, and during that time, he has seen this company evolve from a drug manufacturer to a full-service CDMO.
A tip from Tim:
“If I were to give one tip, it would be to allow more time for the feasibility stage of Process Development, to understand as many factors as possible to align with current capabilities. There can be a lot of pressure to rush through feasibility, whether it’s to save money, increase time to market, or both, but the potential consequences of rushing this phase can be significant.
The fact of the matter is, not every part can be made. Yes, feasibility trials can be costly, but not nearly as costly as moving forward with a project that could’ve been proven unfit from the beginning.”
why process development?
At the end of the day, Process Development is based on sound scientific methods and principles, in combination with risk management tools, which are applied throughout the development process. Quality — which is generally expressed as identity, concentration, and purity of product — cannot be continuously tested, but instead should be assured through process understanding and process control.
Regulatory authorities expect process development to be based on sound scientific methods and principles. Why? Because it works.
around for the evolution
Tim has been part of Tapemark’s engineering department for 15+ years, and during that time, he has helped the company evolve from a drug manufacturer to a full-service CDMO. He has a lot of experience, and he is our resident video expert. Check out all of the videos he has produced for Tapemark to see his expertise.
Tapemark’s Process Development
Through Process Development, our clients rely on us for both our experience and our expertise to put all the pieces together and bring all of the unknowns into the light. In a way, the development process is meant to make it so there aren’t any surprises later on.
Process Development, as we depict it at Tapemark, is done in phases.
- Process Development (or a Process Capability)
- Process Qualification
- Process Validation
- Commercialization (packaging, converting, pouching, and serialization)
Plus, we do Phase Reviews during each phase.
At Tapemark we’ve developed this specific process because it works. Sometimes we receive a lot of information from our clients, and other times we receive very little information beyond their expectations for what the finished product needs to be. In either situation, we rely on these general pillars of our process development to reach our end goal.
Our clients want their part to perform as expected, look as it should, meet all of its patent requirements, and be able to be made as quickly as possible and as high-quality as possible. And all the while, we make sure to take all of their ideas and concerns into consideration while we’re doing it.
What we're able to do is take the formulation and develop something that is critical. At Tapemark the focus is on the science of making the part. And, when it comes to water-soluble films, Tapemark is the leader.
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