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Title:

ADC Manufacturing

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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. – PowerPoint PPT presentation

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Title: ADC Manufacturing


1
ADC Manufacturing
  • https//www.creative-biolabs.com/adc

2
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.

3
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.

4
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.

5
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.
6
Contact Us
45-1 Ramsey Road, Shirley, NY 11967, USA
Email marketing_at_creative-biolabs.com
7
THANKS
  • END
  • Creative Biolabs
  • ADC
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