GBI Biomanufacturing (GBI), one of the world's longest serving contract development and manufacturing organizations (CDMO), is pleased to announce the expansion of its Drug Product (DP) services, to include automated sterile fill and finish capabilities. GBI has the ability to support clients from clinical trials to commercial launch, for both Drug Substance (DS) and DP, all at its one location in Florida, USA. This addition demonstrates GBI's commitment to delivering advanced and flexible Single-Source Solutions™ for the rapidly evolving pharmaceutical and biotech industries.

The ability to provide an in-house, dual approach of automated and manual sterile fill finish, enables GBI to meet the diverse needs of its clients with precision and efficiency. For smaller, early-stage clinical batches or products requiring special handling, manual aseptic vial filling offers flexibility and control. Automated aseptic liquid filling employing ready-to-use components supports higher-throughput production with minimal human intervention, reducing the risk of contamination and increasing batch consistency, making it ideal for both clinical and commercial-scale projects.

"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," said Karl Pinto, & CEO at GBI. "Our facility is equipped with state-of-the-art technology and a team of experts, capable of delivering high-quality, regulatory compliant drug products."

GBI's new three format automated filler has capabilities to support filling in vials, syringes and cartridges, across various drug classes such as biologics, vaccines, bioconjugates and complex large molecules.

The addition of these capabilities aligns with GBI's broader mission to provide its clients with end-to-end development and cGMP manufacturing services as a Single-Source Solution™ CDMO. The company's enhanced fill-finish capacity will simplify its clients' manufacturing supply chains and help in achieving faster timelines, improved scalability, regulatory compliance and the convenience of having both DS and DP material manufactured at one site!