Pre-Launch Manufacturing Issues
The client was faced with looming setbacks of the product development timeline due to a failure of stability studies stemming from the product’s container. A team of BioPhia experts in biocompatability, analytical chemistry, and extractable and leachable testing were assembled to develop a plan to quickly get the product development back on track.
Helping Startup Companies Navigate Regulatory and Product Development Pathways
Excellent technology developed in an academic laboratory led to the development of a medical device as a startup company in a University incubator. However, in order to attract the necessary funding from investors, the company would need to develop regulatory and commercialization plans. A team of BioPhia members were able to provide regulatory, quality and commercialization support to help get this company started.
Addressing USPTO Office Action
A client received an office action from the USPTO indicating that important claims from their patent were rejected because they were obvious and lacked novelty. Review by knowledgeable BioPhia team members were able to develop a response to the USPTO to provide a rationale for the inclusion of the claims
Using Scientific Expertise to Help Solve Technical Roadblocks in Product Development
During development of a new apheresis device, a client detected higher levels of complement activation than historical experience and were concerned that device development would be slowed down. A BioPhia SME was able to review the data and recommend subsequent experiments that when coupled with a review of the literature could explain the activation and keep the development on track.
Providing Specialized Data Analysis to Keep Product Development On Track
A client was unable to make chemical identifications on significant chromatographic peaks from the analysis of extracts from plastic tubing, which threatened to stall their development timeline. A BioPhia SME was able to quickly determine the identifications of the unknowns and keep their development timeline in tact.