Antibody-drug conjugates (ADCs) have ignited a new era of targeted cancer therapy. With 15+ years of contract development and manufacturing experience, Millipore® CTDMO Services offers leading expertise in the conjugation of drug linkers to monoclonal antibodies (mAbs) with facilities specialized for handling highly potent compounds.
ADC technology uses mAbs or other biologics to deliver highly potent active pharmaceutical ingredients (HPAPIs) to targeted cells. In conjugated form, the HPAPIs exhibit more selective therapeutic activity, sparing non-target cells from many of the toxic effects and improving the safety profile. Our clients are quickly adapting these complex technologies and employing them to develop new oncology and non-oncology products that are more targeted and safer.
Today, novel bioconjugates also feature diverse payloads (e.g., oligonucleotides, radionuclides, targeted small molecules, and degraders) and antibody formats (e.g., bispecifics, fragments) to serve diverse applications and indications.Talk to an Expert
With Millipore® CTDMO Services we offer a vast bioconjugation experience with diverse components: novel antibody formats, solubilizers, linkers, and both cytotoxic and non-traditional payload classes.
With Millipore® CTDMO Services we offer:
Our extensive bioconjugation expertise shortens the path to the clinic through rapid production of development-grade ADC construct libraries with antibody and/or linkers and payloads of choice for preclinical lead candidate selection.
Our ADC manufacturing facilities were purpose-built for handling HPAPIs, antibodies, linkers, and for performing complex conjugation processes in GMP suites featuring isolators and specialized handling equipment. Our innovative processing templates include single-use technology and advanced PAT for process control.
Our capacity and capabilities support clinical and commercial manufacturing of ADCs and Bioconjugates. Millipore® CTDMO Services includes regulatory services for IND and BLA activities and we are part of an integrated GMP supply chain network with upstream mAbs, custom linker-payloads, HPAPIs, and solubility enhancers (ChetoSensar™ and PEGs).
ChetoSensar™ is our novel solubilization technology for hydrophobic ADCs.
With decades of PEG synthesis expertise, our technical teams tailor our approach to meet our client’s unique needs, everything from monodisperse to polydisperse, linear to branched, and all varieties of functionalization.
We have developed advanced precursors to synthesize common payloads faster and with less risk.
Biopharma development and manufacturing facility for production of mAbs with 25+ years of GMP experience. Including pilot, and GMP capabilities.
Our API manufacturing site and SafeBridge® certified facility. This 70,000 sq-foot facility builds upon our decades of high potency expertise and makes us one of the largest single-digit nanogram OEL CTDMO providers in the world.
Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production.
Here, we study a case of scaling up an ADC process through a small-scale glass reactor to a fairly large-scale clinical batch under GMP controls.
In this whitepaper, we explore the complexities of developing ADCs and compare the conventional approach to starting with payload core compounds
Learn more about the key elements that were central to the establishment of our commercial manufacturing services for ADCs.
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