Highly Potent / Cytotoxics
HIGHLY POTENT API
Eurofins Contract Development & Manufacturing (CDMO) network of companies offers integrated development services through the entire drug product life cycle, from highly potent active pharmaceutical ingredients (HPAPI) forward.
These niche services are founded on our core strength of innovative process research and development (PR&D), analytical development and cGMP manufacturing. We have developed a reputation for delivering quality services from API’s of various potency to advance a multitude of programs encompassing Drug Substance and Drug Product development, and we regularly produce clinical supplies as well as commercial batches.
Eurofins CDMO in North America is equipped to handle APIs upto SafeBridge Class 4 (OEL’s <30 ng/m³):
- Within our R&D and Analytical Laboratories
- In our dedicated cGMP Kilo Lab Suite and Walk-In Fume Hoods which scales up to ~ 5kg
Operations involving Highly Potent API 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 HPAPI’s. Fully contained facilities featuring single-pass, HEPA-filtered air and pressure-differential airlocks provide physical controls to prevent particulate migration and cross contamination.
CYTOTOXICS
Eurofins CDMO network of companies has state-of-the-art and dedicated cGMP cytotoxic facilities that are well-equipped with state of the art isolators to offer customers a diverse range of cytotoxic API and chemical development manufacturing solutions both in early as well as later stage development programs.
Speed and quality are paramount in our process chemistry and analytical development approach. For commercialization programs, we draw on our teams’ 20+ years of API expertise for process economics, specifications, impurity profile characterization, regulatory strategies and supply chain management considerations. Independent air sampling and surrogate testing demonstrate our containment capabilities. Our vast experience in complex small molecule API synthesis and analytics has been established over many years of safe operation and containment.
Expertise by Area
Research & Development
- Process Research & Development (PR&D) expertise on scale-up synthesis of API’s including synthetic route design / route scouting
- R&D synthesis of starting materials, intermediates, impurities and reference standards
- DoE during process optimization and to support later stage QbD studies
- Safety assessment of chemistry
cGMP Analytical Services
- Analytical Method Development and Validation to monitor Starting Materials, In Process and Final Release testing
- Forced Degradation (Stress) Studies
- Stability Studies to ICH requirement
- Cleaning validations
- Qualification of Reference and Impurity Standards
cGMP Manufacturing
- Non-sterile:
- Liquids: Our newly commissioned HPAPI GMP suites in Ghent (Belgium), have state-of-the-art facilities for non-sterile liquid formulations of Highly Potent API's up to OEB5 level for early phase clinical studies.
Dedicated HVAC equipment and disposable isolators enable us to develop solutions, emulsions, micro- and nanosuspensions. - Solids: At our GMP facility in Artigues (France), we can undertake non-sterile development and manufacturing of Highly Potent API’s up to OEB4 for solid dosage forms (tablets, capsules / batches up to 50 Kg).
Stringent protective and containment tools limit the risks from handling powders and our ventilation, vacuum, HEPA filtration systems and safety airstream helmets ensure complete operators protection.
- Liquids: Our newly commissioned HPAPI GMP suites in Ghent (Belgium), have state-of-the-art facilities for non-sterile liquid formulations of Highly Potent API's up to OEB5 level for early phase clinical studies.
- Sterile: Our GMP facility in Idron (France) offers fill & finish of highly potent cytotoxic drugs with a strong focus on prevention of cross-contamination through campaign manufacturing, validated cleaning practices for isolators and adopting single used materials where possible for items in contact with the product. Manufacturing process 100% under isolators, single use materials / equipment, lyophilization capacities
