How Parimer Helped Onshore an Important International Drug to the U.S.
The project included the redevelopment of a drug substance originally developed in Japan for the international market; However, it had never received US FDA approval. The client approached Parimer to develop a synthetic process to manufacture this drug substance in the USA and support the Chemistry, Manufacturing, and Controls (CMC) needed to get the drug through its Investigational New Drug filing (IND).
The client struggled finding a U.S.-based manufacturer to accept small-batch production for cGMP production. Most companies decline these types of projects because of the small scale.
After much outreach, a group that specialized in government contracting was contacted to undertake this project. The contracting agency then brought Parimer into the project to continue the work and to bring Parimer in to advance the project.
Rare Disease Drug Development Challenges
The project demonstrates unique challenges and difficulty in finding partners who can handle small-batch production. Larger companies tend to bypass such projects since the market size is limited.
That is where personalized attention by Parimer, necessary for such small-scale needs, made them an ideal partner in this niche.
Reverse Engineering Expertise
Parimer successfully reverse-engineered the original drug and manufacturing process, paving the way for U.S. production.
Detail-Oriented
Approach
Parimer’s ability to adapt to changing project needs and focus on the finer details helped overcome key challenges.
Parimer's collaboration is an example of how complex regulatory and manufacturing challenges in the rare disease space are met.
The technical expertise combined with personalized support has not only advanced the small molecule drug project but also shows that Parimer can be a trusted partner in niche pharmaceuticals.
Results and Impact
Looking Ahead
Rare disease drug development can be very challenging, as many large pharmaceutical companies overlook projects with limited market size, but Parimer’s size was an asset to the client’s project. Their approach made them a perfect fit.