Bioconjugation And Protein Modification

Process Development

GBI offers a unique and unrivalled expertise in the research, development, validation and multi-gram manufacture of antibody drug conjugates, and other protein bioconjugates. GBI has many years of experience and multiple patents pending in protein modifications through chemical bioconjugation of cancer drugs, protein toxins, bifunctional ligands and metal chelates (for radio-isotope labeling), antibodies and other biological molecules onto monoclonal antibodies and recombinant proteins..

Conjugation of antibodies with other molecules is a specialty of GBI's development and manufacturing groups. Some typical examples of conjugates manufactured include:

Coupling of small molecule (cancer drug) to antibody
Conjugation of various molecules to carrier proteins such as KLH and albumin as immunogens for antibody generation
Conjugation of highly potent toxins to antibody
Conjugation of two antibodies (full length and fragments)
Cleavable and non-cleavable linkers
Conjugation of Genomic DNA to antibody
Coupling of metal chelates onto recombinant proteins and antibodies (including the difficult IgMs) for radiolabeling
Adsorption of aluminum hydroxide gels onto antibody
Biotinylation of proteins for use with streptavidin- or avidin-based reagents
Enzyme labeled antibodies for signal generation in diagnostic applications
Development of key properties of therapeutic proteins in the optimization of
in-vitro and in-vivo performance

To learn more about our collaboration on radiolabeled antibody conjugates with the Albert Einstein College of Medicine, click here

GMP Manufacturing

Whether the conjugate is a drug toxin (small molecule cancer drugs, plant protein toxins), chelating agents for radio isotopes labeling (diagnostics and therapeutics), adjuvants such as Aluminum Hydroxide-Antibody drug conjugate, or other antibodies, GBI has the ability to develop and perform them at GMP compliant manufacturing scales for clinical applications.

The development group fully understands the issues involved with these processes such as incorporation levels, active site masking and isotope uptake and stability. The manufacturing group has utilized these processes in the production of multi-gram lots of conjugated antibodies that have been administrated in clinical trials throughout the world.
GBI has both the expertise and experience in protein modification utilizing either chemical conjugation or enzymatic digestion. Antibody modification through enzyme digestion is another GBI staff specialty. The production of Fab and F(ab')2 fragments and their subsequent purification can be achieved to a client's specifications. These processes are GMP compliant and scalable to multi-gram lot sizes for clinical applications.
Click here to see:

Dr. Muctarr Sesay’s perspective on the field of Bioconjugation.

* Image provided as a courtesy from Ekaterina (Kate) Dadachova, PhD and Arturo Casadevall, MD, PhD as published in Einstein’s dynamic duo of the decade. Einstein. 2010; Summer / Fall: 38-45.