ADC & Bioconjugation CDMO Services
ADC & Bioconjugation Services for Targeted Therapies
Antibody-drug conjugates (ADCs) are revolutionizing cancer treatment by delivering highly potent active pharmaceutical ingredients (HPAPIs) directly to targeted cells, enhancing therapeutic effectiveness while reducing toxicity to non-target cells. Today’s bioconjugates incorporate diverse payloads and innovative antibody formats, broadening their applications across various therapeutic areas and improving patient outcomes.
With over 15 years of contract development and manufacturing experience, we excel in conjugating drug linkers to monoclonal antibodies (mAbs) in facilities specialized for handling highly potent compounds.
Our comprehensive CDMO services for ADCs and bioconjugates include integrated linker-payload and conjugation capabilities. As a focused and flexible partner, we support you every step of the way, offering also fill/finish capabilities both internally and through strategic third-party partnerships.
To support your pathway from clinical to commercial, we have formed a 5-year strategic alliance with Simtra Biopharma Solutions for streamlined drug substance and drug product ADC manufacturing services.
Our Track Record
#1
We were the first commercially approved ADC manufacturer in North America
100+
Different constructs developed
70+
INDs enabled
260+
GMP drug substance batches released since 2008
100%
Scalable single-use technology in our manufacturing template
PROCESS DEVELOPMENT
Our extensive expertise encompasses a wide range of conjugation and linker-payload chemistries, along with various antibody formats, to support the process development of both traditional and novel bioconjugates.
Conjugation Chemistry Expertise: We specialize in diverse conjugation methods, including stochastic and fully reductive cysteine conjugations, lysine conjugation, and advanced site-directed conjugation techniques such as engineered cysteines, enzyme-assisted conjugation, and the incorporation of non-natural amino acids.
Linkers and Payloads: Our capabilities include process development of constructs with various chemistries, like: cytotoxic payloads, immunotoxins, oligonucleotides, dyes, antibiotics, and chelators.
Proven Process Validation and PPQ Experience: We boast a strong track record, including a successful Pre-Approval Inspection (PAI) in 2020.
Chromatographic Purification Development: We have significant expertise in chromatographic purification techniques.
Innovative Process Technologies: We leverage single-use equipment (since 2017) and Process Analytical Technology (PAT) implementation to achieve advanced process control.
ADC Express™ Services
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.
- Mini-prep scale: 10–20 mg ADC construct ± column purification
- Medium-prep scale: up to 100 mg ADC ± column purification
- Certificate of testing with key quality attributes
Manufacturing
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, including 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).
Production Suite 1 features
- 1,200 sq-ft footprint including airlocks
- EU Grade D room with a Grade C biosafety cabinet
- Unidirectional flow (personnel and materials/equipment)
- Entry, de-gown, and exit airlocks
- Personnel airlocks separate from equipment/material airlocks
- Flexible, multi-scale processing requiring chromatography purification
Production Suite 2 features
- 10,000 sq-ft commercial-scale manufacturing facility supports clinical Phase I/II/III and commercial
- Unidirectional flow (personnel and materials/equipment)
- Rated for flammable use
- WFI system
- Drug weigh-up room (EU Grade C)
- Isolator for drug-linker weigh up
- Single pass air
- Sequential airlocks designed for GMP/containment
LINKER-PAYLOAD TECHNOLOGIES
Monodisperse Activated PEGs for ADC Conjugation
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.
ADCore Payload Intermediates
We have developed advanced precursors to synthesize common payloads faster and with less risk.
- Includes MAYCore™, DOLCore™, and PBDCore™ advanced intermediates
- Enables rapid synthesis of maytansine, dolastatin-10, and PBD payloads
- Suitable for up to phase I clinical studies with process, validation to support path to commercial approval
- Contact one of our experts to request a free sample
A Global Footprint
We are a single organization with a global network to deliver contract development, manufacturing, and testing services across all stages of the molecule value chain.
Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production.
Related Technical Resources
- Establishing Commercial Manufacturing Services For Antibody-Drug Conjugates
In this whitepaper, we discuss how a CDMO leverages 15+ years experience to establish commercial-scale ADC manufacturing capabilities.
- The Evolution of Antibody-Drug Manufacturing
This whitepaper explores how ADC manufacturing has evolved and how CDMOs are adapting to meet customer needs.
- Application of Process Analytical Technology (PAT) in ADC Bioconjugation Process
This whitepaper delves into the benefits of the application of PAT in the ADC bioconjugation process.
- Simplifying Antibody-Drug Conjugate Payload Synthesis Using Payload Intermediates
Learn how the use of payload intermediates can simplify and enhance the development and manufacturing of ADCs.
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