Services at UPM Pharmaceuticals
UPM Pharmaceuticals, a Contract Development & Manufacturing Organization, offers a full spectrum of services ranging from early-stage development to GMP manufacturing of clinical and commercial supplies with the commensurate analytical testing.
In the delivery of these services, UPM consistently exhibits speed, agility, and instinct along with:
Scientific Expertise – Our UPM team has access to some of the industry’s best analytical chemists, formulation design specialists, and manufacturing specialists who are known for developing innovative solutions to difficult development challenges.
Rapid and Responsive Turnaround – Our scientists and managers utilize daily planning meetings and a master scheduling process that provides for timely and responsive project management.
Quality Assurance Documentation – Our highly experienced quality assurance personnel implement complete cGMP quality systems that support formulation development, clinical and commercial batch manufacturing, and analytical work-up.
Our contract development and manufacturing organization offers the following services:
- Pre-Formulation Services Pre-formulation services at UPM are widely recognized for speed, precision and innovative thought across a full spectrum of studies. Based on our client needs, we evaluate a number of parameters for development and manufacture of specific API dosage forms based.
- Brevi-Batch Processing Platform BREVI-BATCH® is a low-cost, cGMP development alternative ideal for clients in search of high quality, proof-of-concept. With a significantly smaller scale than most small-scale R&D formulation batches, Brevi-Batch conserves valuable R&D API using equipment designed for fast set-up, clean-up, and depending on the API toxicity, all processing can be done under containment conditions.
- Low Solubility Solutions With 75% of NCEs classified as low solubility compounds, we made a commitment to providing R&D development and cGMP manufacture of solid dosage forms containing poorly soluble APIs.
- Formulation Development We hold particular specialties in two areas of formulation development. Our first focus is on the development of solid oral dosage forms, including controlled and immediate release formulations in tablet and capsule. second specialty is in the development, testing, formulation and manufacture of semi-solid drugs, including creams and ointments.
- Xcelodose – PIC The Xcelodose system is a precision powder micro-dose system and automated encapsulator with a fill range of 100 micrograms to greater than 100 milligrams. Our team uses its advanced Xcelodose suite, establishing a unique ability to provide clinical manufacturing services specifically for early stage clinical trials and small-scale production.
- Clinical Manufacturing Our contract development and manufacturing organization provides clients with cGMP manufacturing through Phases I – III, semi and fully-automated tableting and over-encapsulation, blinding and preparation of dosage forms, packaging and manufacture of Schedule II – V controlled drugs. We are capable of producing batch sizes ranging from 3Ks to 500Ks, depending on blend density and the process used, and have the capability to control humidity, and handle highly potent compounds.
- Analytical Services As your strategic development partners, UPM designs detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.