Coupled with the company’s existing analytical-method development capabilities, Bend Research has added on-site stability storage and additional GMP testing to efficiently support manufacture of high-quality supplies for clinical use.
The new onsite stability storage will reduce the need to ship samples to a subcontractor, offering clients the enhanced effectiveness of a single vendor. Formulations can be stored at conditions ranging from 5⁰C to 40⁰C/75% RH, meeting industry-standard stability-testing conditions suggested by the International Conference on Harmonization (ICH).
“Our customers asked us to add this on-site capability and we were happy to provide the service. Having this capability on-site will reduce the risks associated with stability sample shipment. It also provides our clients with more rapid product testing and more control,” said Tanya Hayden, Bend Research Vice President.
In addition to stability and release testing, Bend Research continues to offer analytical-method development and method validation for drug products and intermediates in a world-class Quality Control laboratory. The company recently added instrumentation to its existing suite of GMP-qualified equipment. The new instruments, which include a differential scanning calorimeter (DSC) and Malvern particle-size analyzer, will increase capacity and offer clients additional GMP testing options in a single laboratory.
According to Hayden, this expansion is part of a continuing effort by Bend Research to offer its clients quick-to-clinic, full-service analytical capabilities, from drug concept to commercialization.