August Bioservices

Discovery the industry's best kept secret...a fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing, and fill/finish cGMP manufacturing for sterile injectable and topical products – all under one roof. Whether your drug product is liquid or lyo, aseptically filled or requires terminal sterilization, the August Bio team brings to bear more than two decades of drug development and launch expertise. Supporting projects from preclinical to clinical to commercialization and with new multiple high-speed filling lines (vials, syringes, IV bags), August Bio also offers the rarest of CDMO attributes today - immediate, available capacity.

Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches. Developing standardized factory acceptance test (FAT) execution approaches fit for the current times can allow for consistency across equipment vendors and their biopharmaceutical clients. This article describes pragmatic best practices that would support the momentum for new domestic manufacturing facilities.

Since 2020, the CDMO landscape has undergone significant changes. Dearth of fill/finish capacity in the US, exacerbated by COVID and vaccine production, caused market dislocation but also opportunity. With insights gathered through a blind, independent “voice of the customer” industry survey, discover what over 300 decision makers had to say about post-COVID trends and outsourcing plans. Among the intriguing responses captured in the survey – nearly 80% of respondents expressed they were open to, or actively looking for, new CRO/CDMO partners over the past 12 months.

Ryan Downey, Director of Customer Operations, outlines August Bioservices’ capabilities for its customers and what it means to work with them.

Accurately identifying analytes that exceed the ICH identification thresholds is critical to a compound’s safety and stability profile in preparation for NDA filing.