As Outsourcing-Pharma previously reported, the cGMP contract manufacturing organization (CMO) is currently developing and manufacturing more than a dozen advanced polymer-based projects.
“We’ve seen growing interest in advanced polymer work,” Ed Price, PCI Synthesis CEO told us. “Over the last six to seven years, PCI Synthesis had been approached several times each year to develop the synthesis or scale up to GMP polymer-related materials and projects.”
In response, the company has worked on buildings its expertise in the area, and according to price, about two years ago, the number of inquiries and projects began to increase significantly.
“We realized that we have some fairly formidable expertise already but we couldn’t handle all the new synthesis projects customers were asking us to do unless we assembled a dedicated team,” said Price. Subsequently, because of project numbers and demand, the company decided “it was time” to create a dedicated group for advanced polymer development.
Manufacturing
According to Price, PCI creates an entirely new stream of manufacturing projects for its cGMP Newburyport site, which means it is able to take on more projects. “And if any of the projects gets commercialized, then we can actually be the commercial manufacturer,” he added. “That’s important to our customers, too.”
To support material manufacturing, the company’s main technique is GPC or size exclusion chromatography for determining molecular weight. Impurities are also identified and isolated using chromatography to develop various assays.
PCI currently 10 programs either in development or being manufactured under cGMP. These programs range from polymer materials used as implantable materials for medical devices, to drug delivery technologies, in addition to some biodegradable polymeric materials.
“They are all polymer in nature but have very different uses and chemistries,” added Price. “One exciting area is where we develop a traditional API but the delivery method is some polymer-related material.”
According to Price, the company is often developing two projects for a single customer, allowing the customer to focus on one partner, “which makes things easier for everyone,” he added.