Philadelphia, PA -- (ReleaseWire) -- 01/13/2021 --Frontida BioPharm, Inc., a pharmaceutical Contract Development and Manufacturing Organization based in Philadelphia and Chicago areas, announced today the launch of its new Category 1 (CAT.ONE™) in vitro testing and evaluation services to support development and regulatory approvals for abuse-deterrent formulations of pain management and Central Nervous System (CNS) targeted therapies.
To enable the launch of its CAT.ONE™ services, Frontida has hired a team of industry-recognized scientists with a proven track record of success in performing FDA-compliant Category 1 laboratory-based manipulation and extraction studies to support the evaluation and NDA and ANDA regulatory submission of products designed with abuse-deterrent properties. The team joining Frontida - Dr. Eric Kinzler, Chris Altomare, Greg Gironda, and Amanda Camody - previously collaborated on the design and execution of over 60 such studies involving investigational and approved abuse-deterrent products currently prescribed in the USA. To support the team, Frontida has also acquired specialized product manipulation equipment uniquely designed to simulate various abuse techniques (such as chewing, smoking, and vaping) and essential to reproducibly perform Category 1 evaluations. Frontida will leverage its established expertise in analytical development and high-throughput sample processing to rapidly deliver results for these studies.
Ron Connolly, Frontida's Executive Vice President of Business Development, Alliances and Regulatory Affairs, remarked, "Frontida's team is excited to augment our product development expertise for clients seeking to develop and commercialize new abuse-deterrent products. The scientific leadership team we have brought on board to launch our new CAT.ONE™ service offering has proven to be among the best in industry in designing and executing studies to demonstrate whether a product's formulation attributes can reduce its potential for abuse. With the team's proven track record and collective experience, we can quickly support the approval process, provide technical insight into how to incorporate abuse-deterrent properties into the formulation matrix, and help our clients navigate the regulatory and technical challenges of obtaining new approvals and product launches in important therapeutic categories. Coupled with our ability to commercially manufacture and package DEA-regulated products, Frontida can provide a high quality and reliable CDMO partnership to leading brand and generic pharmaceutical companies."
About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a U.S. based, minority-owned CDMO providing drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Our experts are dedicated to helping clients and partners reach the market as quickly and efficiently as possible. Frontida supports pharmaceutical companies in the development, scale-up, and commercial manufacturing of immediate and controlled-release oral solid dose, powder, and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.
Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, Pa. and Aurora, Ill. offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products, and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity to manufacture up to 3 billion tablets and capsules. Our highly experienced, industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.
For more information, please contact Frontida at BD@Frontidabiopharm.com or call +1 (215) 807-1350.