PCI Synthesis, Inc., a drug substance manufacturer of new chemical entities (NCEs) and generic active pharmaceutical ingredients (APIs), announced the formation of its cGMP Advanced Polymer Development and Manufacturing Group, which is currently developing and manufacturing more than a dozen advanced polymer-based projects.
As the largest independent cGMP contract manufacturing organization (CMO) in New England, the addition of an advanced polymer-based materials development and manufacturing capability significantly expands the company’s customer base and reach within this growing market.
The team currently includes several Ph.D.-level polymer chemists with broad expertise in the development, scale up, and eventual cGMP manufacturing of these important materials. The team is also supported by PCI Synthesis’s existing and well-respected Kilo Lab team. Products in development include a broad range of polymer-based materials, including:
- Implantable medical devices including biodegradable implants
- Nano-polymer particle technology
- Combination API and polymer technologies
- Drug delivery technologies
- Therapeutics and excipients
- Medical-grade coatings
The PCI Synthesis Advanced Polymer Manufacturing Group operates out of the company’s development lab in Devens, Mass., and collaborates with its cGMP facilities in Newburyport, Mass.
“PCI Synthesis is the only CMO in Massachusetts 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 and their projects onsite. Advanced polymer manufacturing projects require sophisticated analytical techniques, and it is difficult to find that level of expertise,” said Ed Price, president and CEO of PCI Synthesis.
“All of the projects we undertake begin in our laboratories 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. In addition, PCI is the only CMO in North America that can simultaneously develop and manufacture in one organization both the API and any polymer based technology that may be required for combination products which are becoming more and more prevalent for pharmaceutical development.”