PCI Synthesis, Inc., a drug substance manufacturer of new chemical entities (NCEs) and generic active pharmaceutical ingredients (APIs), has formed a cGMP Advanced Polymer Development and Manufacturing Group, which is currently working on more than 12 advanced polymer-based projects. The addition of an advanced polymer-based materials development and manufacturing capability expands the company’s customer base and reach within this growing market.
 
The team includes several Ph.D.-level polymer chemists with expertise in the development, scale up, and cGMP manufacture of these materials, and is supported by PCI Synthesis’s Kilo Lab team. Products in development include a range of polymer-based materials, including biodegradable implants.
 
The new group operates out of the company’s development lab in Devens, MA, and collaborates with its cGMP facilities in Newburyport, MA.
 
“PCI Synthesis is the only CMO in MA doing this kind of advanced cGMP polymer manufacturing, which is a big advantage for local life sciences and pharma firms, since we’re able to collaborate with them onsite. Advanced polymer manufacturing projects require sophisticated analytical techniques, and it is difficult to find that level of expertise,” said Ed Price, president and chief executive officer of PCI Synthesis. “All of the projects we undertake begin in our labs enabling our teams to not only improve many of our polymerization processes, but also to adopt the latest analytical techniques to support the manufacturing of cGMP polymer materials from kilos to tons.