Our Capabilities
Eurofins CDMO has integrated Active Pharmaceutical Ingredient (API) development services for a wide range of API classes, including Highly Potent APIs. These services are founded on the company’s core strength of innovative Process Research & Development, Analytical Development, and GMP Manufacturing with a reputation for delivering quality services for APIs of various potency to advance our clients’ programs. Research & Development suited and separated cGMP scale-up facility can handle potent compounds to less than 30 ng/m (Safebridge™ Class 4).
Our containment
Eurofins CDMO operations involving High Potency compounds are conducted with the highest level of work safety and regulatory compliance. Facility design, equipment, engineering controls and proper operation of facilities and equipment achieve the desired level of containment for HPAPIs.
Full containment facilities featuring single-pass, HEPA-filtered air and pressure-differential airlocks provide physical controls to prevent particulate migration. The various suites are isolated. Primary control is achieved by using full containment equipment such as barrier isolators, engineered glassware, and closed system transfers.
Our Specialized Services
Research and Development
GMP production
GMP analytical
Antobody Drug Conjugate
Research and Development
Our Research & Development expertise in API synthesis extends to:
- Route scouting
- Scale up process development
- Reference standard development
- R&D synthesis of starting materials, intermediates and impurities
- Process optimization studies – DOE, Spike, Fate & Purge
- Process validation
- Process safety assessment
GMP Production
Our team is experienced with the development and validation of several molecule API processes that are in various stages of regulatory approval globally. Our solutions are tailored to your needs:
- QC, QA, Regulatory and CMC support
- GMP API manufacturing processes tailored to your needs
- Technology transfer specialists
Up to ~5kg single batch per walk-in fume hood
GMP analytical
As part of API development services and stand-alone services, we provide analytical testing for your projects at various stages in the drug life-cycle. Our specialties include:
- Analytical method development and validation to monitor Starting Materials and Products Quality Control, In-Process Controls and Final Release testing.
- Forced Degradation (Stress) Studies.
- Stability Studies to ICH requirements.
- Cleaning validations
- Qualification of Reference and Impurity Standards.
Antibody Drug Conjugate Development
At Eurofins CDMO, our comprehensive suite of Antibody Drug Conjugate (ADC) development and manufacturing services includes synthesis of small molecule API, including high potent API. From linker design to warhead development, our full suite of services ensures a seamless integrated approach to your ADC projects.
Explore our outsourcing solutions tailored to your needs