ADC Manufacturing

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

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.

  • cGMP antibody manufacturing: The Creative Biolabs cGMP antibody manufacturing service platform has the capacity of pilot (5~35 L) to large scale (> 100 L) preparation of therapeutic antibodies or recombinant proteins using various expression systems (hybridoma, mammalian cell lines, insect cell cultures, and microbial expression systems). We also offer process development services under this platform to help establish cGMP stable cell lines, cell banking, upstream process optimization, and downstream scale-up…
  • cGMP organic synthesis: Creative Biolabs provides customized chemical synthesis service and fine chemicals based on our well-established organic synthesis chemistry pipeline in R&D and cGMP environments. This pipeline enables us in preparing regular or highly tailored linker molecules bearing different release mechanisms, modifying payload drugs for proper conjugation chemistry, preparing new payload derivatives for the purpose of drug development, and formulating the drug-linker complex for ADC manufacturing.
  • ADC conjugation, purification, and filling: ADC conjugation is achieved in cGMP certified reactors after small-scale conjugation protocol verification. The therapeutic impurities are removed utilizing advanced filtering devices such as ultrafiltration and tangential flow filtration (TFF) systems. The ADC product are purified using single-use chromatography systems and finished by filling into aseptic vials via the cGMP sterile filling pipeline.

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!

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