Experience.
Finishing.
Aseptic Fill & Finish
Whether you’re seeking primary packaging as a stand-alone service or integrated into a project, GBI is happy to offer our over 30 years of experience in aseptic fill and finish services to clients ranging in size from virtual biotechs to multinational companies.
Contact UsGBI’s Sterile Fill Finish Capabilities and Process
Our ISO5 filling suite provides customized, economical, and compliant liquid filling of your products in cGMP conditions to support human clinical trials in the United States, Europe, and Asia. Our aseptic filling process operations are fully validated for batch fills up to 400 cartridges or up to 2,000 vials with volumes of 1 mL to 10.0 mL per vial (and larger fill volumes available as needed for late-stage and commercial applications).
Our semi-automated process uses a programmable pump and manual fill nozzle, which provides improved yields for small lot sizes. Fill checks are performed at predetermined intervals and all fill operations are consistently observed and environmentally monitored by quality personnel. Vials are stoppered and crimped after filling, with sealing and fill checks performed outside the fill room and monitored by quality personnel.
Regulatory Compliance and Specialized Fills
The automated AST fill and finish system meets most worldwide regulatory agency requirements including the FDA as well as the Canadian and European Union regulatory authorities. This includes compliance with Annex 1 of the EU’s cGMP guidelines.
We also have unique experience with small-scale, customized and specialized fills such as light-sensitive products, controlled (DEA-regulated) vaccine conjugates, exosomes, and fragile ADC conjugates.
Aggregate Removal Development and GMP Manufacturing for a Conjugated Theranostic Product
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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® while overcoming the many process and product-related challenges associated with an IgM antibody.
