EXECUTIVE INTERVIEW - Norwich Pharma Services: Synchronized Outsourced Solutions for Contract Development & Manufacturing

Norwich Pharma Services, located in Norwich, NY, is a recognized leader in full-service contract pharmaceutical development and manufacturing. Norwich’s predominant focus is developing and manufacturing solid oral dose tablets, and capsules. Norwich’s base manufacturing capabilities include in-bin and V blending, high shear/low shear/ fluid bed granulation, fluid bed drying/top spray granulation/ bead/pellet coating, tableting, encapsulation (powder, pellet, tablet, combination, and liquid fill), pan coating, and tablet printing. Norwich’s packing capabilities include both blister and bottle packaging.

Through its Synchronized Outsourced Solutions, Norwich offers customers a single-source provider with the highest level of quality and reliability from product development and Phase I-IV clinical trial materials and bio-studies, to scale-up and commercial manufacturing through clinical services. For more than 127 years, Norwich has built a reputation for dependable product supply and established an unparalleled history of regulatory compliance. Drug Development & Delivery recently spoke with Kristin Arnold, PhD, Norwich’s Vice President of Product Development and Technical Services, to discuss the company’s long history in pharmaceutical manufacturing, Norwich’s evolution as a contract development and manufacturing organization, the “perfect” client, and Norwich’s role as a service provider from start to finish.

Q: Norwich has been manufacturing pharmaceuticals for many years. Can you provide our readers some of the history?

A: Norwich Pharma Services began as Norwich Pharmacal Company in 1887. Through the years, and under various owners, it has been named Morton – Norwich Products, Norwich Eaton, and OSG Norwich Pharmaceuticals. In 2007, the site was sold to Alvogen, and the name changed to Norwich Pharmaceuticals. In October 2013, the name was changed to Norwich Pharma Services to reflect the company’s role as a contract services provider. With such a long history, the site holds a very special place in the community.

Q: What services does the company offer?

A: Norwich is a full-service contract development and manufacturing organization. We offer services from Phase I product development through pilot scale, clinical production, scale up, registration, clinical services, and commercial manufacturing. In addition, we are able to help our customers with product optimization and formulation troubleshooting solutions.

Q: What type of products do you work with at Norwich?

A: We work with both immediate- and modified-release products. We have experience with standard tablets and capsules but also work with unique dosage forms, such as laser-drilled tablets, extruded and spheronized beads, Wurster coated beads, tablet-in-tablet, granules, and mini-tablets.

Q: Can you tell our readers about Norwich’s development facilities?

A: Norwich’s development and pilot-scale facilities are located within 8,000 square feet of space that is DEA approved, solvent, and potent compound (OEL3) capable. We have two dedicated areas, one for development and the other for GMP pilot-scale batch manufacture. We support all phases of drug development. In addition, we have an analytical laboratory dedicated to our development group. They are skilled at developing, transferring, and validating methods, and they perform all of the testing on our development batches. The development and pilot-scale facilities, equipment, and technology mirror Norwich’s commercial capabilities. This allows for a direct transfer from the pilot plant to commercial operations and from the analytical laboratories to quality control laboratories, enabling a fast transition to the market.

Norwich has made substantial capital investments in its pilot-scale facilities throughout the past 3 years. In the past 12 months, Norwich nearly tripled its pilot-unit capacity to a total of 19 rooms. This expansion provided an increase in overall capacity as well as added new capabilities to handle higher potency products. Each of the 19 units has the ability to handle Occupational Exposure Limits (OELs) for drug potencies ranging from category 1 to 3.

Q: What would you describe as Norwich’s “ideal” customer?

A: Our ideal customer is a virtual or small- to mid-size specialty pharmaceutical company that is looking for a true partner in its drug development and manufacturing needs. We like to believe that we are not just a provider who is a “pair of hands” but a partner who will really collaborate in the process. As drug compounds move through the development phases, we work closely with customers to ensure the drug is proceeding according to the development plan, timeline, and budget. As we progress, and the development and process learnings are realized, we work closely with our customers to make rapid response adjustments/revisions to keep the program on track.

Q: Sourcing APIs from a single source can pose a challenge for drug developers. What can Norwich do to deal with this issue?

A: Norwich had a recent experience with this challenge while preparing for a commercial launch with one of our long-term customers. The market projections on this particular product had increased causing a probable API supply issue. Our customer responded quickly and engaged another API supplier, but the physical properties of the new API were different than the current supply used for finished dosage development. The issue was further complicated by the high percentage of the API in the finished product. Norwich quickly developed a Design of Experiments (DOE), which provided operating ranges that would accommodate both sources of active. Because Norwich had partnered with this customer from the beginning of finished dosage development, Norwich had substantial experience the client was able to leverage in resolving this supply issue.

 Q: What does the future hold for the industry, and what has your facility done to prepare for it?

A: Within the solid dose market, there is both good news and bad news. Overall, growth in solid dose products has been stagnant, and there is adequate capacity in the industry to handle demand for the near future. However, within certain niches of the solid dose market, there are opportunities for Norwich, due to our focus on complex solid oral dosage form delivery. Traditionally, these specialty type products can be manufactured much more efficiently in equipment that is sized for the product demand. Norwich has put an emphasis on being just the right size in terms of equipment offerings as well as its overall service offerings, particularly for specialty pharmaceutical and virtual companies.

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