mAb development and manufacturing
We support mammalian‑based monoclonal antibodies used in ADC programs, from early process development through GMP drug substance production.
Antibody drug conjugates (ADCs)
Develop and advance ADC programmes
Eurofins CDMO specialises in the development and scaling of antibody drug conjugates (ADCs), and support programmes from early-stage development through commercialisation.
- mAbs - up to 2000 L reactor capacity
- High‑potent linker–payload development - Safebridge® Class 4 high‑potent capability (OEL <30 ng/m³) with rigid isolator containment
- Bioconjugation: up to 200 L
- Sterile Fill Finish: 2 - 20 mL vials and prefilled syringes; up to ~86k units/day
- BSL‑2 pilot plant and GMP analytical lab support
By bringing biologics, high‑potent small‑molecule chemistry, bioconjugation, analytical development together on the same campus, we simplify CMC execution and support progression from early development through clinical and commercial supply.
Designed for phase-appropriate development
ADC programmes evolve rapidly from discovery through early clinical phases. Our experts partner collaboratively to align development activities with programme stage, regulatory expectations, and scale up considerations.
Preclinical, clinical, and commercial
CMC strategy development and documentation
Risk-based decision-making across disciplines
ADC capabilities overview
Our expertise
- Upstream and downstream process development
- CL2 / BSL‑2 facilities
- Non‑GMP and GMP manufacturing up to 2000 L scale
- GMP scale expansion 2000 L
- Fed‑batch and perfusion capabilities
- Technology transfer and comparability support
Linker-payload production (high-potent API)
Our small‑molecule scientists develop and manufacture linkers and payloads components to support a range of ADC designs.
Our experience
- De novo synthesis and route development
- Linker types including peptides, PEGs, disulfides, small molecules, and DOTAs
- Payload classes including Auristatin, Exatecan derivatives and novel compounds
- High‑potent API development and GMP manufacturing
- Safebridge® Class 4 containment capability (OEL <30 ng/m³)
- Solid‑state science and impurity control strategies
ADC bioconjugation
Eurofins CDMO Alphora offers development and GMP manufacturing of ADCs using established and emerging conjugation approaches.
Our capabilities:
- Enzyme‑mediated and site‑specific conjugation strategies
- Development and scale‑up of conjugation processes
- Non‑GMP and GMP conjugation up to 2000 L
- DAR control of ADCs
Analytical development & characterisation
Our analytical teams provide phase‑appropriate methods to support ADC development, release, and stability.
Our capabilities:
- Analytical method development, qualification, and validation
- ADC characterisation, including DAR assessment
- Release and stability testing (non‑GMP and GMP)
- Reference standard and impurity support
- Integrated analytical strategy aligned with CMC objectives