Comprehensive Bioconjugation Solutions

There have been advances in the field of biologics that enable scientists to synthetically modify recombinant proteins and monoclonal antibodies and use them in therapeutics, diagnostics and other fields. Thanks to bioconjugation, these biomolecules can be used to reveal enzyme function, to track cellular events, to determine protein biodistribution, to image specific biomarkers, and to deliver drugs to specific cells. 

At Goodwin Biotechnology, we offer a unique and unrivaled expertise in the manufacture of multi-gram protein bioconjugates like antibody drug conjugates (ADCs). We will develop at the earliest stages a scalable, GMP-compliant, economical and efficient process using a risk based Quality by Design (QbD) approach that is designed to manufacture your ADC product in an expedient manner and meet all appropriate quality requirements relative to safety, purity, identity, potency, and immunogenicity.

For well over a decade, we have specialized in the conjugation of monoclonal antibodies and recombinant proteins to make ADCs as well as radioimmunoconjugates. We are known for the chemical bioconjugation of these products using bifunctional ligands, drug toxins like plant protein toxins and cancer drugs, metal chelates for use in radio-isotope labeling, chelating agents that are used in radio isotopes labeling for therapeutic and diagnostic purposes, and adjuvants like Aluminum Hydroxide-Antibody conjugate.

Other conjugations we do are conjugations using cleavable and non-cleavable linkers, Genomic DNA to antibody, protein-to-protein conjugates, and two antibodies (fragments and full length). We do protein biotinylation for use with avidin- or streptavidin-based reagents and we develop key properties of therapeutic proteins to optimize in-vivo and in-vitro performance. Our team also has expertise in protein modification through chemical conjugation or enzyme digestion.

We understand the importance of such factors as incorporation levels, isotope stability and uptake, and active site masking in the manufacture of bioconjugates and we take extra care to ensure you get the highest quality product.

We also understand that common bioconjugation reactions like the lysine amino acid residue coupling, cysteine residue coupling, N- and C- terminus modification, tyrosine residue coupling, and tryptophan residue coupling often lack efficiency and chemoselectivity given that they depend on native amino acid residue presence (which are usually readily available and hinder selectivity).

Our team has the necessary training and experience for the job. We have a state-of-the-art manufacturing plant and we manufacture bioconjugates at GMP-compliant manufacturing scales. We have a number of patents pending. Bioconjugates synthesis has a lot of challenges that range from the simple, nonspecific use of fluorescent dye markers to the complex, highly cytotoxic antibody drug conjugates design.

Goodwin Biotechnology can work with cytotoxic payloads up to Safebridge Level 3 within our own facilities (e.g., doxorubicin or methotrexate); however, for ADCs utilizing highly potent cytotoxic payloads (e.g., maytansine, auristatin, DM4, or tubulysin) requiring a Safebridge level 4 / Merck level 5 facility, Goodwin has collaborated with Coldstream Laboratories where we seamlessly execute all conjugation processes within Coldstream’s high-containment facilities, from proof-of-concept through late-stage clinical trials and large-scale cGMP manufacturing or commercial products.

We have customized solutions since we understand that our clients have unique needs. We will involve you in the entire bioconjugation process and you will have the final say on major decisions. We offer a Single Source Solution™ or a one-stop-shop when it comes to biotechnology and we invite you to try our comprehensive solutions.