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August Bioservices

August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.

https://augustbio.com/
51-200 employees

Growth Trajectory

August Bioservices is poised for growth through facility expansions, increased manufacturing capacity, and a focus on innovative technologies like LNPs. Their participation in industry events signals market expansion plans, while investments in new instrumentation like UPLCs support their commitment to advanced analytical capabilities. They are also actively hiring, indicating team growth and further expansion.

Technical Challenges

Manufacturing high-complexity formulations
Managing uncommon container sizes and fill volumes
Scaling sterile manufacturing processes
Ensuring data integrity and compliance with cGMP regulations
Development, optimization, and bridging of analytical methods

Tech Stack

Liquid fillLyophilizationAseptic processingTerminal sterilizationGlass containersPlastic containersLiquid ChromatographyGas ChromatographyMass SpectrometryUPLCs

Team Size

Research & Development
Laboratory Services
Manufacturing
Commercial teams (sales/marketing)

Key Risks

Maintaining high-quality standards and compliance with cGMP regulations amid rapid expansion.
Competition from other CDMOs in the sterile injectables market.
Challenges in scaling up manufacturing processes for high-complexity formulations.
Potential disruptions in the supply chain for critical raw materials and equipment.

Opportunities

Leveraging their hybrid model to attract clients seeking both large CDMO capabilities and personalized service.
Expanding their market share in the growing sterile injectables market.
Developing expertise in emerging technologies like LNPs to address the needs of innovative drug developers.
Forming strategic partnerships with biopharmaceutical companies to secure long-term manufacturing contracts.
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