An antibody-drug conjugate (ADC) is formed by covalent biochemical conjugation of a monoclonal antibody with highly toxic payload drugs via a small molecular linker. ADCs are emerging candidates for targeted cancer therapies and due to the extreme toxicity of their payloads, ADCs are often considered as a new generation of highly hazardous and toxic pharmaceutical products. The unique nature of ADC presents challenges in its large-scale production. ADC manufacturing requires proper facilities that strictly follow the criteria and guidelines of cGMP-standard bio-macromolecule production. What’s more, these facilities are extremely stringent about aseptic production and they need to be operated under an occupational exposure limit (OEL) below 50 ng/m3. With over a decade of dedicated work, Creative Biolabs and our collaborators have established manufacturing platforms and pipelines fully designated for large scale recombinant protein, therapeutic antibody, and ADC manufacturing.
ADC manufacturing is a multistep process that can be divided into three distinct stages: cGMP production of the antibody, cGMP synthesis of the drug-linker complex, and conjugation to form an ADC. The conjugated antibodies undergo extensive purification and finished as ADC products upon the completion of fill-finishing.
Creative Biolabs and our collaborators are also equipped with state-of-the-art analytical platform (MALS/IR, LC/MS/HPLC, UHPLC, CE, icIEF, UV/VIS, Moisture analysis, CCI…) for ADC characterization and ensure the purity and quality of the end products. Process development services are also available for optimizing conjugation strategy, formulation, purification scheme, and scale-up production of ADC to gram scale.
With our Ph.D. level science team and years of experience in the field of ADC development and production, the ADC manufacturing platform at Creative Biolabs will greatly facilitate your ADC projects and push the progress towards clinical trials. Please contact us for more information and a discussion to see how we can be involved in your ADC development projects!
For Research Use Only. NOT FOR CLINICAL USE.
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