ENTERPRISE SPONSOR: Steriles

Pharmaceutics International, Inc. (Pii), one of Our Road to CPhI Milano sponsors discuss how they are preparing to face the future of healthcare.

The Mission of the Company

In late 2019, Pii made a significant shift to its business strategy, shifting from a specialty generics and branded product company to refocus operations as a dedicated CDMO and leverage its pharmaceutics knowledge and experience developing products to support customers. The company is currently strengthening its core competencies and taking the steps necessary to attract customers and ensure that these customers will be provided with the same standards of quality and service that Pii has applied to its in-house products.

Pii continuously adds offerings at small and medium scale for clinical trial and commercial manufacturing for both oral and parenteral drug delivery technologies. These offerings are driven either by our perception of the current and future needs of the industry or by a specific problem encountered by a customer (e.g., solubility, bioavailability, toxicity, potency) that requires a solution.

One recent significant capability expansion was the provision of lyophilization cycle development services to support customers in early-phase development of lyophilization processes, in a manner that can be easily transferred and scaled-up for commercial-scale manufacturing. Pii also recently expanded its aseptic filling capabilities and capacity with the addition of a new, fully robotic filling line — including a GENiSYS^® filling machine from Automated Systems of Tacoma, LLC — for aseptic pharmaceutical and biotech product manufacturing, on the small to medium scale, per strict cGMP requirements. The integration of proven isolator-barrier and automated technologies provides the right balance of flexibility with advanced system features, enabling the processing of aseptic, toxic, and cytotoxic drug products. Multiple programs in early- to late-stage development have already been identified as candidates for transition to the new line, which can be used to produce anywhere from a few hundred to 50,000 vials per day.

Pii is constantly monitoring developments in the industry to identify opportunities for proactive investment in new technologies, particularly in medical journals and patent literature, to give them sufficient lead-time to invest in and establish these new capabilities to meet demand. The company particularly eyes trends that would be best addressed by a synthesis of the capabilities Pii already possesses (e.g., lyophilization of potent compounds) to leverage our core competencies to provide optimal solutions.

One of Pii’s ongoing goals is to position itself on the cutting edge of technology, as an early adopter and investor in new technology solutions. To that end, the company is working to shift its research focus to include more developmental research as well as applied research, prioritizing next-generation drug manufacturing platforms and novel drug delivery technologies.