Services

ADC Manufacture


With appropriate technical equipment and years of experience in bio-pharmaceuticals, Creative Biolabs provides one-stop customer-oriented services of antibody drug conjugate (ADC) manufacture. We have been dedicating ourselves to helping every custom to facilitate their project in a highly productive and cost-effective way.  


ADC manufacture


ADCs are tripartite drugs comprising three parts: the antibody, the payload and the linker; more specifically, a tumor-specific monoclonal antibody conjugated to a potent cytotoxin via a stable linker. The three components of ADC together give rise to a powerful oncolytic agent capable of delivering normally intolerable cytotoxins directly to cancer cells, which then internalize and release the cell-destroying drugs. Nowadays, ADCs are an emerging class of biotherapeutics which have great potential for the treatment of cancers, and simultaneously require unique supporting infrastructure to meet biopharmaceutical industry standards for safe, effective and reliable manufacturing. Because of their complexity, ADCs offer unique opportunities and challenges for the manufacturers. There are three main elements to manufacturing ADCs: bulk production of the monoclonal antibody; bulk production of the small molecule drug; coupling of the monoclonal antibody and the small molecule drug via the use of an appropriate linker. Therefore, producing an ADC requires both biologic-based and small-molecule manufacturing capabilities, Creative Biolabs provides various cell expression systems to produce the antibody, and utilizes synthetic chemistry processes for the manufacture of the linkers and the small molecule drugs. What’s more, the state-of-the-art equipments of Creative Biolabs can overcome one of the greatest technology challenges in the manufacture of cytotoxin by providing an aseptic biological manufacturing environment that allows safe manipulation of highly toxic drugs.      

Moreover, another biggest challenge in manufacturing the whole ADC molecule is controlling all the components that go into the final conjugation step and retain their activity after the chemical conjugation. With deep understanding of this point, Creative Biolabs assembles a strong team with experienced Ph.D level scientists, well trained technicians and ADC specialists to provide a comprehensive custom ADC manufacture service and we are committed to offering top-quality ADC products with high activity to every customer. Typically, ADC manufacturing process of Creative Biolabs includes antibody modification, conjugation and formulation. With different classes of payloads and antibodies, we will choose the most appropriate linkers and conjugation strategy to perform ADC manufacturing including various analysis. Creative Biolabs can perform robust processes and also allow transfer to cGMP-compliant manufacturing. In collaboration with the worldwide partners, GMP team of Creative Biolabs provides services including biopharmaceutical contract R&D, process development, cGMP manufacturing, QA & QC solutions for scientific research, preclinical, clinical and commercial supply.

As we deepen our understanding of what makes a successful ADC, an increasing number of ADCs will likely become viable and potential treatment strategy as single agents or in combination with chemotherapy. Scientists from Creative Biolabs have successfully established platforms to assist your researches in ADC development for both scientific and clinical purposes. However, there is no general guideline for individual ADC strategy. Creative Biolabs provides customized-design ADC services depending on the antibody, drug and tumor target. We will design and select the most suited strategy evaluated based on the efficacy and toxicity of an individual ADC construct.


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