Payload-Linkers

Comprehensive Payload-Linker Solutions Tailored for Your Success

Payload-Linkers

The right payload-linker system can be the distinguishing factor between a successful bioconjugate candidate and a failed one, making it vital to partner with a CDMO that offers specialized knowledge and experience. At Piramal Pharma Solutions, we have the expertise and technology to develop payload-linkers that are specifically tailored to your unique needs.

Our drug substance facility in Riverview, Michigan serves as our Center of Excellence for dedicated payload-linker development and manufacturing, offering an extensive range of services to optimize our clients’ systems. These capabilities are provided as standalone services or as part of ADCelerate™, which combines the strength of our integrated global network to accelerate bioconjugates from R&D to GMP production, with guaranteed delivery at a fixed price.

With our payload-linker solutions, we’ll help you develop successful bioconjugate candidates and ultimately bring lifesaving therapies to patients in need.

Discover the Advantages of ADCelerate

Our Payload-Linker Capabilities

Development & Manufacturing Services
  • Process research, development, & optimization aiming for impurity control & process efficiency ahead of scale-up for later phase manufacturing
  • Dedicated HPAPI suites capable of handling OEL down to OEB6 (200ng/m3) & more specifically to10ng/m3
  • A new, 1070sf suite capable of handling 4-6 HPAPI projects simultaneously
  • Experience with a diverse range of materials
    • Payloads: MMAE, Tecans derivatives (including Exatecan), Doxorubicin, etc.
    • Linkers: PEGylated, peptide-based, next-generation ligands, etc.
  • Deep chemistry expertise to handle a wide range of linker technologies
  • Purification by flash chromatography & prep HPLC up to 150mm
  • Tray lyophilization at up to 1m2 of area & filter dryer
  • Manufacturing of batches ranging from 200-300g with preparative column purification to multikilogram, column-free processes using a contained agitated filter dryer
  • Disposable & permanent isolators
Analytical Services
  • Analytical methods development, qualification, & validation
  • Specification development & material testing
  • Impurity identification, characterization, & synthesis
  • Qualification of reference samples
  • Stability studies & testing
  • Cleaning procedures
  • Product-specific analytical verification methods
Backed by
  • 30+ years handling highly potent materials; scientists who are fully trained & highly experienced in working with HPAPIs & payload-linkers
  • Proven track record in balanced, fast delivery & a fit for purpose approach from early preclinical & First Time in Human
  • FDA approved facilities
  • Supply-chain mitigation via the supply of advance intermediates from Piramal’s internal site
  • A brand-new, state-of-the-art lab to increase capacity to 200-300g utilizing prep HPLC purification & lyophilization
    • Supporting large-scale development & manufacturing via crystallization & Silica flash purification
ADC Services

Unlock the potential of your bioconjugate candidates with our payload-linker solutions. Contact us today to get started.

Piramal Pharma
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