DCAT Week ’18: PolyCrystalLine Expands Solid-State Chemistry CapabilitiesBy
Stefano Giaffreda, PhD
Stefano Giaffreda, CEO and Co-Founder of PolyCrystalLine, a Bologna, Italy-based privately owned contract research organization (CRO) active in solid-state chemistry, announced a new and strategic investment at the DCAT Week ’18 Member Company Announcement Forum, which was held Monday, March 19, 2018 in New York.
PolyCrystalLine provides solutions to optimize and control the crystallization process of active pharmaceutical ingredients. Giaffreda explained that the company’s new investment is to transform the company from a CRO into a contract development and manufacturing organization (CDMO) by building a new department dedicated to cGMP kilo-scale production to enable the company to expand the range of its services and to increase its specialization in the optimization of synthetic processes and crystallization, scale-up, and production of small batches (1 to 5 kg scale).
Giaffreda provided key highlights of the site expansion project that will allow early development of cGMP products, crystallization by design within a cGMP process, and production of small-scale cGMP batches for validation scale and clinical trials. The new site expansion will involve the completion of a 6,000-square-foot research facility adjacent to the company’s current site in Bologna.
The expansion adds to the company’s flexibility, efficiency, and capability in contract manufacturing, by offering solid-form consistency from development to manufacturing.