UPM is excited to announce the opening of its newly designed and qualified Solids Formulation R&D Facility.
The facility is comprised of 4,000 square ft with capabilities for a wide range of pharmaceutical formulation development, including four processing suites fitted with down flow booths, a wash room, dedicated feasibility materials storage, humidity controlled capsule shell storage, and an in process testing room. The facility contains dedicated R&D equipment that is state of the art and scalable to clinical processing, including wet and dry granulation, particle size reduction, encapsulation, multi-layer tableting, granules, coating, hot melt extrusion and liquid fill into hard shell capsules.
Batches can be processed with as little as a few hundred grams of powder allowing clients to evaluate a broad range of processes before selecting one to scale up. Additionally this saves API that is often expensive or in limited supply.
Jim Gregory, UPM’s CEO says, “At UPM we have a strong history of formulation development expertise, now combined with state of the art R&D facilities and equipment. We are your partner from concept to commercial on your journey to market.”
UPM Pharmaceuticals is a contract development and manufacturing organization (CDMO). The company focuses on analysis, stability testing, formulation development, and cGMP manufacturing. UPM works with small and large companies on solid dosage forms, including capsules and tablets. Its facilities allow for small batches for clinical trials to large-scale commercial production. In April 2014, the company agreed to manufacture two products for Amerigen Pharmaceuticals in a 10-year supply term.
A Pharma Tech report argues that drug manufacturing companies must continue to study the attributes of the materials, including cohesion, permeability, and density. The report author also identifies raw-material specifications as a potential source of improvement in the industry and says that the Food and Drug Administration (FDA) is working with manufacturers on an excipients database.
In solid-dose processing, process analytical technologies (PAT), real-time monitoring, online monitoring, and near infrared (NIR) analysis are helping manufacturers improve efficiencies and quality. For example, when compression forces are monitored, tablets can be rejected if a compression irregularity is identified. Other tools can monitor a tablet’s weight, hardness, and thickness.