Boyer and other industry leaders will review the unique challenges facing the sterile injectable supply chain during a panel discussion 9 a.m. Wednesday, March 13. The panel, “Key Trends for Sterile Injectable Manufacturing and Outsourcing,”
DCAT Week – sponsored annually by the Drug, Chemical and Associated Technologies Association (DCAT) – is one of the pharmaceutical industry’s largest and most important annual educational and networking meetings. Last year, nearly 2,000 people attended the DCAT Week keynote address.
Companies developing sterile products are being challenged by significant regulatory pressures and uncertainty in the supply base, which can affect quality, compliance and cost competitiveness. As a result, shortages of sterile injectable pharmaceuticals are on the rise, according to the U.S. Food and Drug Administration.
The DCAT Week panel will lead a discussion examining trends and steps underway at contract manufacturing organizations (CMOs), as well as pharmaceutical companies, to improve operational security while remaining competitive. Boyer will focus on the changing regulatory climate and its influence on traditional drug sponsor and CMO relationships.
“The industry is seeing simultaneous increases in both outsourcing and regulatory actions, which are changing how drug sponsors and CMOs collaborate,”
During DCAT Week, OsoBio will serve as the registration partner and reception host for a session called “Facilities of the Future: Single-Use Technologies”
OSO BioPharmaceuticals Manufacturing, LLC, is a CMO that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. The company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of its Albuquerque, N.M., facility, OsoBio has manufactured more than 250 distinct commercial presentations in every major therapeutic category. The U.S. Drug Enforcement Administration (DEA) has granted OsoBio registrations for Schedule II through V controlled substances. Learn more at osobio dot com.