Platform designation for ADC linker-payloads so manufacturing data carry across
Many antibody-drug conjugates share the same linker and payload chemistry. Regulators should let companies reuse the manufacturing evidence rather than repeating it for every new antibody.
FDA's platform technology designation programme (draft guidance 2024, from the 2022 omnibus legislation) allows a well-characterised technology used in an approved product to be referenced in later applications. ADC linker-payloads (deruxtecan, vedotin, site-specific enzymatic conjugation from Synaffix or Araris) are natural platforms: the conjugation process, payload synthesis, impurity profile and much of the non-clinical toxicology are antibody-independent. The proposal is for FDA, EMA and PMDA to jointly designate ADC linker-payload platforms and publish what data may be referenced, so a new ADC on a designated platform files only antibody-specific CMC and toxicology.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
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not linked directly; found by shared links- IdeaContinuous-flow synthesis of ultra-potent ADC payloads to ease the capacity squeeze
Shares Payload (ADC), Manufacturing cost and time for living and radioactive medicines, Antibody-drug conjugate (ADC).
- TermProdrug
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- ProductInotuzumab ozogamicin
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- TermSMCC (thioether, non-cleavable)
- TermSulfo-SPDB (disulfide)
- CompanyTubulis (Gilead)
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).
- TermMaleimidocaproyl (mc), non-cleavable
- TermAcid-labile hydrazone (AcBut)