Experience.
Finishing.
Aseptic Fill & Finish Services from a Trusted US-Based CDMO
With over 30 years of experience, GBI offers precise, flexible, and fully cGMP-compliant aseptic fill and finish services to support biologics and advanced therapeutics at every stage of drug product development and manufacturing cycle. As a leading US-based CDMO, GBI serves clients ranging from virtual to mid-sized biotechs, medical institutions to multinational pharmaceutical companies, offering both standalone filling services and integrated solutions from upstream processing to final packaging.
Our sterile filling capabilities are ideal for bio-conjugates, monoclonal antibodies, vaccines, and other complex and high-value clinical products requiring stringent aseptic handling.
Contact Us
End-to-End Sterile Fill Finish Capabilities
GBI’s ISO 5 aseptic filling suite provides liquid fill finish services under validated cGMP conditions for clinical trial material in the U.S., Europe, and Asia. We support:
- Up to 2,000 vials per batch (1 mL to 10.0 mL fill volumes)
- Up to 400 cartridges for small-lot precision filling
Our semi-automated fill system utilizes a programmable pump and manual nozzle—ideal for high-value biologics with small batch sizes. Fill integrity is assured through consistent environmental monitoring, in-process checks, and hands-on QA oversight throughout the operation.
GBI utilizes the AST GENiSYS C coupled with the vial seal module VSM-20 nested RTU container system. The GENiSYS C, a three format (vial, syringe, cartridge) platform, meets the needs for automated filling of clinical trial material. GBI is qualified to perform:
- Up to 3,000 vials per batch in 2R, 6R and 10R fill formats
Regulatory Compliance & Specialized Fill Capabilities
US companies trust GBI for its regulatory rigor. GBI’s aseptic operations align with global standards, including:
- FDA requirements
- Canadian and other international regulatory guidelines
We also specialize in customized, fills for complex biologics, including:
- Light-sensitive therapeutics
- DEA-controlled conjugate vaccines
- Exosome-based products
- Fragile bio-conjugates
This flexibility makes GBI one of the most reliable CDMO companies in the US for precision sterile manufacturing of niche and theranostic therapies.
Integrated cGMP Manufacturing & Drug Product Development
Our fill finish services integrate with GBI’s broader capabilities in cell culture development, upstream processing, bioconjugation, and cGMP manufacturing. Whether you’re preparing clinical trial material or scaling up for commercialization, GBI ensures quality and consistency across the entire product lifecycle.
We are very pleased with the highly skilled scientists at GBI, who met the challenge of developing and scaling up the process to manufacture a monoclonal antibody using their perfusion cell culture process, and utilizing their bioconjugation expertise to prepare the IgM-ligand conjugate needed for purification of our Q-Cells®.”
Aggregate Removal Development and GMP Manufacturing for a Conjugated Theranostic Product
DownloadPartner with a Full-Service CDMO for Aseptic Manufacturing
From drug product development to commercial readiness, GBI provides industry-leading aseptic fill and finish services backed by deep technical expertise and proven performance. As a seasoned cGMP manufacturer, we help clients bring complex, high-value biologics to market with confidence.
Contact us today to learn more about our sterile fill finish solutions and how we can support your next clinical or commercial project.
