Our Single-Source Solution™ is designed to support the entire life cycle of bioconjugates from development through cGMP manufacture.
Whether your conjugate is a chelating agent for diagnostics or therapeutic radioisotope labeling, an adjuvant like aluminum hydroxide, an antibody-drug conjugate, or another antibody, GBI can develop and manufacture them at cGMP-compliant scales for clinical applications (and commercial launches beginning in 2023).
GBI’s Bioconjugation Experience
Our experience in the field includes:
- Coupling small-molecule cancer drugs to antibodies
- Conjugating various molecules to carrier proteins (such as KLH and CRM 197) as immunogens for antibody generation
- Opioid conjugate vaccines
- Conjugating two antibodies, both full-length and fragments
- Cleavable and non-cleavable linkers
- Conjugating genomic DNA to antibodies
- Coupling metal chelates onto recombinant proteins and antibodies (including difficult IgMs) for radiolabeling
- Adsorption of aluminum hydroxide gels onto antibodies
- Biotinylation of proteins for use with streptavidin- or avidin-based reagents
- Enzyme labeled antibodies for signal generation in diagnostic applications
- Conjugating fluorescent dyes to antibodies
- Developing key properties of therapeutic proteins in the optimization of in vitro and in vivo performance
Because of our extensive background in bioconjugation, our development team has a full, in-depth understanding of the issues that accompany these processes such as incorporation levels, active site masking, and isotope uptake and stability.
Our Schedule II Capabilities
In 2018 GBI was awarded a Schedule II manufacturer license from the Drug Enforcement Agency to handle controlled substances. We have used these controlled substances to successfully develop and manufacture protein conjugate vaccines for opioid addiction.