ADC Manufacturing

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ADC Manufacturing

• https//www.creative-biolabs.com/adc

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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.

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Three distinct stages of ADC manufacturing

• cGMP production of the antibody
• cGMP synthesis of the drug-linker complex
• conjugation to form an ADC.
• The conjugated antibodies undergo extensive
  purification and finished as ADC products upon
  the completion of fill-finishing.

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Antibody Drug Conjugate Manufacturing

• 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. Whats 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.

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Adc Manufacturers
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.
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Contact Us
45-1 Ramsey Road, Shirley, NY 11967, USA
Email marketing_at_creative-biolabs.com
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THANKS

• END

• Creative Biolabs

• ADC