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Agility.

Bioconjunction Services

Bioconjugation Services

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).

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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.

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Sally A. Quataert, Ph. D., Chief Executive Officer,
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We have selected GBI based on the years of experience they have in bioconjugation and in developing and manufacturing cADCs, radioimmunoconjugates, and other conjugates. They demonstrated a great deal of flexibility, worked within our budget, and delivered our ADC ahead of schedule.

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Sally A. Quataert, Ph.D., RQAP-GLP Chief Executive Officer, For-Robin, Inc.

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