August Bioservices is a contract development and manufacturing organization that provides end‑to‑end services for sterile injectable therapeutics, covering process development, analytical testing, and commercial sterile fill‑finish. Leveraging state‑of‑the‑art labs and advanced sterile filling lines, they enable rapid optimization, scale‑up, and regulatory‑ready production for pharma and biotech clients.
Funding
$88.6M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Pharmaceutical companies developing sterile injectable therapies often face fragmented development processes, limited access to advanced analytical and manufacturing capabilities, and lengthy timelines to scale from lab to commercial production. These challenges can delay market entry and increase costs while maintaining regulatory compliance.
Solution
August Bioservices offers a fully integrated contract development and manufacturing organization (CDMO) that consolidates product development, analytical testing, and sterile manufacturing under one roof. Leveraging state‑of‑the‑art laboratories and advanced sterile filling lines, the company supports clients from early process development through commercial fill‑finish and distribution. Its expertise in design of experiments (DoE), quality by design (QbD), and technology transfer enables rapid optimization and scale‑up of formulations. In‑house analytical services provide method development, validation, and comprehensive testing—including USP <1> release, stability, extractables/leachables, and container closure integrity—ensuring regulatory readiness. The end‑to‑end model reduces hand‑offs, shortens development cycles, and delivers high‑quality sterile injectable products at scale.
Target Audience
Primary customers are pharmaceutical and biotech companies developing sterile injectable drugs, including small‑molecule biologics, vaccines, and drug‑device combination products, that require end‑to‑end development and commercial manufacturing services.
Features
- On‑site process development and optimization with DoE and QbD study design, execution, and statistical analysis
- Technology transfer and scale‑up capabilities from 1 L laboratory batches to 4000 L production using stainless steel and single‑use systems
- Full suite of analytical services: method development, validation, raw material release, USP <1> injectable testing, stability across ICH zones, and testing for residual solvents, elemental impurities, extractables/leachables, photostability, nitrosamines, and container closure integrity
- Advanced sterile filling lines for vials, pre‑filled syringes, IV bags, and drug‑device combination products with automated visual inspection, labeling, packaging, and serialization
- Integrated in‑house testing strategy that accelerates data generation, improves quality oversight, and supports regulatory compliance
- Collaborative project management approach providing a single point of contact throughout development, manufacturing, and distribution