The unsung link between drug discovery and patients: enter the CDMO
Life sciences innovation is frequently born in a lab whether university, commercial, virtual or other. But translating cutting-edge research into products and therapies that benefit humans requires the expertise of many different scientists and other professionals, all adding their own unique perspectives.
Centralized providers of such in-depth and granular insight include contract research organizations, contract manufacturing organizations, and contract development and manufacturing organizations (CDMO). Recro Gainesville is one of the only CDMOs in Georgia. The company specializes in development through commercialization of oral solid dosage forms. It has a longstanding focus on modified drug release profiles for tablet and capsule formulations. This includes reformulating drug products that previously required multiple doses per day to once-a-day formulations.
“Converting a multi-dose regimen to single-dose provides tremendous gains in patient adherence,” Recro Gainesville Executive Vice President and General Manager Scott Rizzo told us. “Discovery is difficult enough. How do you apply that discovery for the maximum public health benefit? That is the question we answer through the services we provide, particularly from a development standpoint. So many novel therapies originate from very small teams or from labs with high potential but with limited development assets or resources. Our CDMO solutions are key to bringing new drug products to the market.”
Regulatory filings, efficacy analytics, production consistency, safety and repeatability of product: These are all hurdles to clear when developing oral solid dosage forms for clinical and commercial manufacturing – especially for complex formulations.
“Small to medium sized companies and those ‘two-scientists and a molecule’ operations need support. They need the regulatory, tech transfer, quality control, and scientific expertise that gives their therapy the best chance of entering patient care,” Scott said. “While we serve several commercial public pharmaceutical companies, living in an innovation and development-focused ecosystem as robust as Georgia’s is key. For novel therapies, it’s a win-win.”
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“Speed will always be an issue when getting new therapies to patients, whether we’re working on an emergency resupply for one of our clients, commercializing an orphan drug, or reformulating a single-dose product from an existing, approved multi-dose regimen,” Scott said.
“There is no sacrificing safety or quality for speed. But our product development team, which includes more than a dozen Ph.D.s, does this type of work every single day. We love what we do and want to be good citizens to the state and society at large. We are here to support the industry and do the work needed to get therapies to patients quickly and safely. If, for some reason, our team can’t help a scientist or small team with a novel therapy or sterile injectable, we almost certainly know someone who can.”
About Recro Gainesville
Recro Gainesville provides oral solid dosage form development, regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in modified release oral solid dosage forms and DEA controlled substances, Recro has the experts to deliver clients’ most complex pharmaceutical development and manufacturing projects in its best-in-class, 120,000-square-foot manufacturing facilities.
About Georgia Bio
Georgia Bio (GaBio), founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization which works to improve access to innovative technologies and grow Georgia’s life sciences economy. Members include companies, universities, research institutions, government groups and other industry associations involved in discovery and application of life sciences products and related services that improve the health and well-being of people throughout the world.