Translating benchtop processes and preclinical experiments into ready for human use products poses a vast array of challenges. Often referred to as the valley-of-death, the difficulty in simultaneously scaling-up, qualifying processes, documenting, and manufacturing in an approved environment is beyond the reach of most academic or small business researchers. The level of funding to overcome this challenge is often out of reach except for the most lucrative pharmaceuticals, leaving the vast majority of promising research untested in the clinic.

Midwest GMP was founded to bridge the gap between benchtop research and cGMP manufacturing for early clinical use of extended-release pharmaceuticals. Designed for only early-stage clinical builds, Midwest GMP was designed to be small and nimble while simultaneously meeting all of the necessary requirements for cGMP manufacturing of extended-release pharmaceutical formulations.

Midwest GMP was born out of need. After successful benchtop manufacture and preclinical testing of an extended-release pharmaceutical to treat opioid use disorder, researchers at Purdue University were unable to find acceptable cGMP manufacturing for a phase I clinical trial. After considerable weighing of options, they partnered with Akina Incorporated to build out small scale cGMP capabilities, thus founding a new Akina division named Midwest GMP. This major investment in capabilities required acquiring space, installing and qualifying a cleanroom, outfitting the cleanroom with equipment, establishing a quality system, and hiring experienced personnel. While MW GMP is a start-up, we have staff and consultants with more than 100 years of combined cGMP experience to aid in fulfilling the initial goals of its founding.