August Bioservices

Articles

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.

Rare Ability: US-Based CDMO Has Available Fill/Finish Capacity, Development & Testing

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.

Accelerating Biopharmaceutical Virtual FATs in a Pandemic

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.  

US-based development, testing and fill/finish capacity is now available

They focus on sterile injectables in multiple container sizes from vials to syringes to flexible IV bags— coupled with an analytical services department.

The current CDMO market is constrained for those who need the capacity to start their innovative work, which is where August Bioservices comes in.

With robust tools and a strong team, they can solve difficult challenges with formulation, commercial configuration, the timing of a project, and analytical characterizations.

Videos

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

A US-Based, Injectables-Focused CDMO with Available Capacity and End-to-End Capabilities

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