Originally published on 9/01/2018 at Drug Development & Delivery
UPM Pharmaceuticals: A Variety of Platforms to Analyze Complex DrugSubstances
As the pharmaceutical industry continues to experience consolidation and downsizing, more aggressive outsourcing efforts are underway with regard to analytical services. UPM Pharmaceuticals is a CDMO that uses a Quality-by-Design (QbD) approach to method development to ensure that the most appropriate and robust techniques are developed for each specific application. This approach also ensures that analytical methods are developed from the start to transfer to commercial operations. UPM accomplishes this through the use of diverse array of technology platforms, including the latest UPLC/HPLC, GC and FTIR systems, particle size and TOC analyzers, UV spectrophotometers, and state-of-the-art software systems for data acquisition and document management.
“Not limiting itself to a specific platform makes UPM’s analytical services group highly versatile and capable of responding to a range of needs, including the development of methods for novel compounds and controlled substances,” says Daniel Dixon, Vice President of Quality Control, UPM Pharmaceuticals.
Collaboration between UPM and its clients is an important facet of the approach to analytical method development. Similarly, close cooperation with other fully qualified laboratories that have complementary capabilities ensures that UPM can provide the entire spectrum of analytical support required for drug development and commercialization, says Mr. Dixon. In addition, UPM has worked with outside contractors to develop specific HPLC columns for the chemical entities it tests. “As a CDMO, it is paramount to have an analytical group that is agile and aware of the trends in order to handle these more complex methods as they come along,” he says. “Specifically, we have increased our staffing and knowledge base to develop the more complex methods required for the complex drug substances in today’s pharmaceutical pipeline.”