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GBI Biomanufacturing (GBI), a contract development and manufacturing organization, (CDMO), is growing its drug product services by adding automated sterile fill-finish services. Currently, the CDMO is able to assist clients beginning at the clinical trial stage all the way through to commercialization, for both drug substance and drug product.
From a customer service standpoint, having both automated and manual sterile fill-finish capabilities allows GBI to tackle client needs in an efficient manner. There are a multitude of options to accommodate different product types. For example, manual aseptic vial filling could be an option for smaller, early-stage clinical batches, while automated aseptic liquid filling supports higher-throughput production with less human involvement.
“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, chairman and CEO, 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 also has a new three-format automated filler that can assist with filling when it comes to cartridges, syringes, and vials, which spans multiple drug classes, including bioconjugates, biologics, and complex large molecules, and vaccines.
In other GBI news, the CDMO signed its second master supply agreement for commercializing a radioimmunoconjugate product, establishing its interest expanding its healthcare via the radiopharmaceuticals avenue.2
“We are happy to see more clients entrusting us with their long-term commercial product needs,” added Pinto. “This announcement signifies the strength, longevity and strategic nature of our partnership with this fast growing, global radiopharmaceutical leader. The radiopharmaceutical space is witnessing unprecedented growth, and GBI is proud to be at the forefront of this transformative industry.”
And, as of last month, the company entered a partnership with Allterum Therapeutics, centered around 4A10, a monoclonal antibody (mAb) that targets CD127, a receptor expressed by a various cancers.3 Allterum’s initial Phase I/IIa trial will prioritize patients with acute lymphoblastic leukemia (ALL); following this will be later expansion into trials involving other CD127-expressing hematological malignancies.
References
1. GBI Biomanufacturing Expands Capabilities with Automated Aseptic Fill-Finish for Drug Products. PR Newswire. November 20, 2024. Accessed November 25, 2024. https://www.prnewswire.com/news-releases/gbi-biomanufacturing-expands-capabilities-with-automated-aseptic-fill-finish-for-drug-products-302310690.html
2. GBI Secures Commercial Manufacturing Contract, Solidifying Leadership in Radiopharmaceutical Manufacturing. PR Newswire. January 15, 2024. Accessed November 25, 2024. https://www.gbibio.com/gbi-secures-commercial-manufacturing-contract-solidifying-leadership-in-radiopharmaceutical-manufacturing/
3. GBI Biomanufacturing and Allterum Therapeutics Announce Strategic Collaboration to Manufacture Therapeutic Antibody for Clinical Trials. PR Newswire. October 7, 2024. Accessed November 25, 2024. https://www.gbibio.com/gbi-biomanufacturing-and-allterum-therapeutics-announce-strategic-collaboration-to-manufacture-therapeutic-antibody-for-clinical-trials/