GBI Biomanufacturing has expanded its capabilities to include automated sterile fill/finish capabilities at its Florida, US site.
This expansion will allow GBI to support its biotech and pharmaceutical clients in the production of drug substances and drug products at varying scales from clinical trials to commercial launch.
The company will employ a dual approach to sterile fill/finish, with automated and manual services available.
Through this hybrid service, GBI can produce early-stage clinical batches which often require special handling manually, while also offering automated, high-throughput production of aseptic ready-to-use components with a low contamination risk.
GBI's automated filler is capable of handling the filling of vials, syringes and cartridges, and is suitable for a range of drug classes such as biologics, vaccines, bioconjugates and complex large molecules.
By expanding its aspetic fill/finish services, GBI Biomanufacturing hopes to provide clients with end-to-end development and cGMP manufacturing services.
Providing drug substance and drug product material manufacturing under one roof, according to GBI, can help customers to:
- Simplify their supply chains
- Achieve faster timelines
- Improve scalability
- Adhere to reguatory requirements
- Improve the convenience of manufacturing
CEO of GBI Biomanufacturing, Karl Pinto, commented: "Adding automated aseptic fill-finish capabilities to our service offerings strengthens our ability to meet the diverse requirements of our clients, from start-up biotech to established pharmaceutical companies,"
"Our facility is equipped with state-of-the-art technology and a team of experts, capable of delivering high-quality, regulatory compliant drug products."