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Highly Potent / Cytotoxics

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HIGH POTENCY

Eurofins Contract Development & Manufacturing (CDMO) 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.

  • Research & Development and Analytical facilities equipped to handle HPAPI’s up to SafeBridge Class IV
  • cGMP manufacturing plant facilities can handle highly potent API’s
  • Niche API programs can be supported in dedicated kilo lab suite

Operations involving High Potency compounds including cytotoxics and hormones 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 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 Eurofins CDMO 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
  • Sterile: Manufacturing process 100% under isolators, single use materials / equipment, lyophilization capacities