GBI Biomanufacturing announced today that it expanded its drug product (DP) services to include automated sterile fill and finish capabilities.
Plantation, Florida-based GBI can support clients from clinical trials to commercial launch, both for DP and drug substance (DS). All of this can take place at its Florida plant, delivering advanced and flexible Single-Source Solutions for the pharmaceutical and biotech industries.
The company says the ability to provide an in-house, dual approach of automated and manual sterile fill-finish, enables GBI to meet the diverse needs of clients with precision and efficiency. Manual aseptic filling offers flexibility and control for smaller, early-stage clinical batches or those requiring special handling. Automated filling supports higher-throughput production with minimal human intervention. That reduces contamination risk and increases batch consistency, according to a news release.
GBI’s new three-format automated filler has capabilities to support filling in vials, syringes and cartridges. This spans drug classes like biologics, vaccines, bioconjugates and complex large molecules. The company says its enhanced fill-finish capacity simplifies supply chains to help achieve faster timelines, improved scalability and regulatory compliance.
“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.”
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