Novasep Finorga sell "CDMO services for ADCs"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
CDMO services for ADCs
Specifications
- Application: Full CDMO support for antibody-drug conjugates (ADCs), from preclinical (1 mg-100 mg) through Phase I cGMP scale (100 g-500 g)
- Certification Standard: cGMP-compliant ADC manufacturing for Phase I clinical supply
- Regulatory Status: Platform analytical methods with six-week turnaround for preclinical fast-track studies
Other Information
Additional Description:
Novasep offers full CDMO support for antibody-drug conjugates, from process development to cGMP production. Options include a fast-track offer for preclinical studies (1 mg to 100 mg ADC samples, platform analytical methods, six-week turnaround), a Phase I package (100 g to 500 g cGMP scale with process and analytical development plus stability studies), a clinical and validation package (process and analytical validation, registration batches, BLA regulatory support), and custom packages.
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