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首页 / 产品 & 服务 / 制药 / 毒性化合物生产服务 / ADC载体开发和生产服务
ADC载体开发和生产服务
制药

ADC载体开发和生产服务

Bandeau 22

25 years of experience in cytotoxics synthesis and industrial chromatography
to address the challenge of ADC payloads manufacturing

Custom development and manufacturing services for the production of Antibody-Drug Conjugate payloads

Novasep offers a full range of services for the production of ADC payloads ranging from process development to commercial scale manufacturing taking into account the additional specificity of these complex molecules.

Specific Production Challenges

Novasep Payload SynthesisADC payloads typically present high toxicity at extremely low doses when unconjugated, resulting in very low Occupational Exposure Levels (OEL) to ensure workers protection. Novel payloads even present OEL lower than 0.03 µg.m-3.8h-1 (Safebridge® Category 4).

These complex molecules often present chemo-selectivity issues and variable stability under normal operating conditions. Their production requires chemistry carried out at small scale under high containment in a GMP compliant environment.

For these reasons, any activity related to ADC payloads production requires a contained and specially designed environment, including those for R&D, analytical, production, storage.

Track-record

Experience and knowledge in production and purification of payloads for ADCs since 2006
Classes of ADC payloads produced by Novasep include:

  • Maytansines
  • Anthracyclines/Rubicins
  • Pyrrolobenzodiazepines/PBDs
  • Auristatins
  • ADC linkers

Cytotoxics and ADC payload track record:

  • 5 new projects in development on average each year
  • 4 commercial parenteral APIs produced on site
  • 2 novel commercial compounds launched in the past two years

Novasep has had several successful PAI audits, including one in 2009 and in 2013. Learn more about our quality management system.

New Facilities for Commercial Scale Production of ADC Payloads

Novasep Purification Suite ADC PayloadsThe new production facility, dedicated to the production of ADC payloads, was commissioned in 2014. It includes a chemistry workshop with the capability to manage reactions down to -60°C and filter dryers fit for the production of kilogram-scale batches. The asset also includes a purification workshop with two separate Prochrom® preparative HPLC lines. This new facility enables commercial production (kilogram-scale batches) of payloads with a OEL 0.03 µg.m-3.8h-1 and lower under full cGMP conditions.

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  • Highly potent API
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  • ADC Brochure
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  • Smart synthesis & advanced purification
    Smart synthesis & advanced purification
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  • Low temperature chemistry
    Low temperature chemistry
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  • Global offer for pharmaceuticals
    Global offer for pharmaceuticals
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