The Science of Bioconjugation
Conjugation of monoclonal antibodies and recombinant proteins to other molecules is a specialty of Goodwin’s development and manufacturing groups. Bioconjugates present complex challenges during process development and manufacturing. Whether the conjugate is a chelating agent for radio isotope labeling (diagnostics and therapeutics), adjuvant such as Aluminum Hydroxide-Antibody conjugate, controlled substances-protein vaccine conjugates, fluorescent dye or other ligand, Goodwin has the ability to develop and perform them under GMP compliant manufacturing scales for clinical applications.
Full Protein Bioconjugation Capabilities
We offer a unique and unrivaled expertise in the research, development, characterization, validation, and multi-gram manufacture of Antibody Drug Conjugates (ADCs), radioimmunoconjugates, conjugate vaccines, and other protein bioconjugates. We nearly 20 years of experience, extensive peer reviewed journal publications, white papers, and patent publications in protein modifications through chemical bioconjugation of cancer drugs, protein toxins, bifunctional ligands and metal chelates (for radio-isotope labeling), controlled substances for vaccine conjugates (haptens conjugated to carrier proteins), peptides, fluorescent dyes, and other biological molecules and ligands onto monoclonal antibodies, recombinant proteins and other biological molecules. Click here for Goodwin’s publications on bioconjugation.
Our full service offering for bioconjugates provides our clients with proof-of-concept, process development, and scale up and cGMP manufacturing of the bulk drug substance and the final vialed product for early stage through to late-stage clinical trials. Click here to request a white paper description of bioconjugates that we’ve completed from proof of concept and early- to late-stage materials generated for human clinical trials.
Goodwin is licensed to handle: Controlled Substances
In 2018, Goodwin was awarded a Schedule 2 manufacturer license from the DEA (Drug Enforcement Agency) to handle controlled substances. Goodwin has used these controlled substances to successfully develop and manufacture protein conjugate vaccines for opioid addiction currently undergoing early Phase clinical trials in the US. Click here for press release. These opioid conjugate vaccines have been developed to address the rising incidence of substance abuse disorder on a global scale.
Bioconjugation Process Development and cGMP Manufacturing
Goodwin Biotechnology offers a unique and unrivaled expertise in the research, development, validation, and multi-gram manufacture of antibody drug conjugates, and other protein bioconjugates. Goodwin Biotechnology 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 Goodwin Biotechnology’s development and manufacturing groups. Some typical examples of conjugates manufactured include:
- Coupling of small molecule (cancer drug) to antibody
- 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
- Opioid Conjugate Vaccines
- 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
- Conjugation of fluorescent dye to antibody
- Development of key properties of therapeutic proteins in the optimization of in vitro and in vivo performance
What Clients Say
We are extremely happy that the highly skilled scientists at Goodwin Biotechnology found a way to make a viable conjugate. When we first evaluated the random conjugation results, we were seriously considering going back to the drawing board and developing a new antibody. Finding a solution to this significant challenge saved us years of development work and a significant amount of money. It is clear that the decision to select Goodwin Biotechnology has paid off well for us.Panacea Pharmaceuticals (now Sensei Bio)
Vendor selection is important to product development and as such we have selected Goodwin Biotechnology for manufacturing scale-up because of their track-record in antibody conjugation, including radiopharmaceuticals.
We selected Goodwin Biotechnology to develop the ADC 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 they delivered our ADC ahead of schedule.
The Goodwin Approach
Goodwin has the experience, expertise, and capability to develop and manufacture a wide range of antibody and protein drug conjugates incorporating many small and large molecules, ligands, chelators, fluorescent dyes, controlled substances and others. The successful development of an effective bioconjugate combines elements of science with years of experience understanding the nuances of optimizing the antibody-linker pairing, particularly since covalent cross-linking of the antibody onto a linker is essential for proper drug delivery to the intended target cells.
With nearly 20 years of experience in the bioconjugation CDMO arena, Goodwin offers full service of numerous bioconjugates providing our clients with materials for proof of concept, process development, scale up and cGMP manufacturing for use in preclinical Tox animal studies, and early to late stage clinical trials.
Advance your project
For more information on how Goodwin can advance your Bioconjugation project, contact us.