GBI Biomanufacturing (GBI), a CDMO, is expanding its Drug Product (DP) services to include automated sterile fill and finish capabilities. GBI supports clients from clinical trials to commercial launch, for both Drug Substance (DS) and DP, at its location in Plantation, FL. This expansion aims to deliver advanced and flexible Single-Source Solutions for the pharmaceutical and biotech industries.
 
The ability to provide an in-house, dual approach of automated and manual sterile fill finish, enables GBI to meet diverse client needs with greater 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 enhanced fill-finish capacity aims to simplify clients manufacturing supply chains and help in achieve faster timelines, improved scalability, regulatory compliance and the convenience of having both DS and DP material manufactured at one site.