Outsourcing Formulation Development & Manufacturing

Originally published on 6/6/2018 at Drug Development & Delivery

 

Tablets and capsules remain UPM’s primary focus for meeting client needs in these areas, including specialty forms such as ODTs (oral disintegrating tablets), minitabs, immediate- and modified-release solutions, and neat API encapsulation. UPM also has extensive expertise in oral peptide development. Changes in 2016, including the implementation of the manufacturing quality assurance (MQA) initiative as well as the realignment of laboratories and specific capabilities, have ensured more efficient production and more consistent operations to achieve faster time to market, even for challenging APIs, explains Hulya Sahin, PhD, Senior Director Product Development, R&D, UPM.

Pharmaceutical R&D Laboratory

“As a client-focused CDMO, UPM is vested in providing more than just capacity for the production of drug products on a fee-for-service basis,” says Dr. Sahin. “We don’t own our own products or any proprietary technology, but we are open to working with a client’s technology, dedicating space and capital investments for a solid partnership.”

In addition, UPM’s R&D group works with a deliverables-driven system for scheduling, development, and production. “Although a smaller CDMO, UPM offers proof-of-concept services through clinical and commercial manufacturing support – but with the personalized, responsive service of a well-funded, family-owned organization that emphasizes customer service and satisfaction,” says Dr. Sahin.

In the last five years, UPM has expanded its facilities from 40,000 sq ft to over 750,000 sq ft, and has grown its employee base from 65 to 265 while modernizing operations. Says Dr. Sahin: “We have greatly invested in capital improvements, including the construction of a state-of-the-art R&D feasibility lab with five processing rooms and scalable equipment that supports our clients from development to commercialization. We have also added a low humidity suite and serialization capabilities.” In addition to the capital expenditures, UPM has hired development scientists with backgrounds in formulation development, including modified-release technologies for tablets and capsules, and process development, clinical supplies manufacture, and scale-up and technology transfer.

 

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