Research and development
Our research and development expertise in HPAPI synthesis extends to:
Highly Potent API (HPAPI)
Utilising our core strengths of process research and development, analytical development and GMP manufacturing, we deliver integrated development services for different API classes, including Highly Potent APIs.
Containment measures
Eurofins CDMO's 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 and are fully isolated. Primary control is achieved through use of full containment equipment such as barrier isolators, engineered glassware, and closed system transfers.
Our specialised services
- Route scouting
- Scale-up process development – up to 5L reactor
- Reference standard development
- Prep chromatography
- R&D synthesis of starting materials, intermediates and impurities
- Process optimisation studies – DOE, Spike, Fate and Purge
- Process validation
- Process safety assessment
GMP production
Our HPAPI facilities offer stringent protective and containment tools to prevent cross-contamination and ensure complete operator's protection. Our team is also experienced in the various stages of global regulatory approvals required for highly potent APIs.
Our high potency API capability includes:
- Rigid and flexible isolators; dedicated HVAC equipment and disposable isolators
- Up to ~5kg single batch cGMP kilo laboratory suites and walk-in fume hoods
- 3-100L reactors and small glass reactors
- Non-sterile liquid formulations up to OEB5 level
- Non-sterile solid dosage forms up to OEB4 level (batches up to 50kg)
- Preparative high-performance liquid chromatography (Prep Chromatography)
- Air monitoring / surrogate testing
- Technology transfer specialists
- QC, QA, Regulatory and CMC support
GMP analytical development
We provide analytical testing at various stages in the drug life-cycle, either as part of high potency API development services or as a stand-alone service. Our specialties include:
- Analytical method development and validation to monitor starting materials and product 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
At Eurofins CDMO, our comprehensive suite of Antibody Drug Conjugate (ADC) development and manufacturing services includes synthesis of highly potent APIs. From linker design to warhead development, our full suite of services ensures a seamless integrated approach to your biologics projects.
