Expertise at every step
Our expertise
With a focus on sterile injectable drug development and manufacturing, August Bio provides deep industry expertise, brand new facilities and equipment, and comprehensive capabilities, delivered through collaborative partnerships between our clients and our engaged team of subject matter experts
Comprehensive service portfolio serving a broad range of customer requirements
- High-complexity formulations and processes
- Small, medium, and large-scale filling
- Wide variety of container types, sizes, and fill volumes
Explore our end-to-end capabilities
We serve our clients, at any phase, from early development through commercial-scale manufacturing. At every step, our technical experts work in partnership with our clients to optimize processes and advance programs from clinical or commercial manufacturing.
Link to: Product Development – new
Product development
Our R&D team is comprised of scientific leaders who are skilled in characterization, formulation development, process development, product optimization, and technology transfer.
Link to: Analytical Services – new
Analytical services
Our on-site Chemistry, Microbiology, Raw Material, and Analytical Development laboratories can perform almost all testing required for regulatory submission Module 3.
Link to: Analytical Services – new
Manufacturing
Our technology supports projects at any scale utilizing fully isolated filling lines for vials, syringes, and IV bags, as well as automated visual inspection, assembly, labeling, packaging, and serialization.
Our commitment to quality
Our Quality Management System (QMS) is ICH-based to enable compliance across regulatory regions. Our facility and processes are fully compliant with FDA Sterile Injectable Guidance and EU GMP Annex 1 requirements.