Process Chemistry Services

Eurofins Advinus offers a full range of process research and development services spanning kilogram scale synthesis for efficacy and toxicology studies, to multi hundred kilogram cGMP scale-up for clinical development and commercial use. Our Scientists and Process Engineers have excellent experience in developing new, safe and efficient route for complex molecules. Our scientific team is well versed with spike/purge studies, impurity identification, in silico analysis to assess Potential Genotoxic Impurities (PGIs) and developing analytical methods to quantity, process safety studies, polymorph and salt screening and QbD based process development for late phase compounds. The chemistry services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Eurofins Advinus clients range from academic institutions to small biotech to big pharma, and also agro chemical companies.

Capabilities Include:

  • Route Scouting, Fit for purpose Process development and optimization, Process safety studies, Analytical method development and validation, stability studies, scale-up of drug substance for Tox and clinical studies
  • Well-equipped, QP-audited cGMP Kilo lab, pilot plant and commercial production plant
  • An excellent scientific team of skilled, well-trained and highly experienced synthetic organic chemists, analytical chemists, and chemical engineers to follow a regulatory-driven, phase-appropriate process development strategy to support various stages of Chemistry, Manufacturing & Control (CMC)
  • Experienced scientists with deep understanding of drug discovery and development to ensure speedy and flawless execution of CMC campaigns in a cost-effective manner

Chemistry Services Include:

Custom Synthesis:

  • Gram to multi hundred kilo gram scale synthesis (non-GMP & cGMP)
  • Focused libraries, Scaffolds, building blocks and Intermediates
  • Reference and standard compounds
  • Metabolite and impurity synthesis
  • Stable label compounds (deuterium labelled)
  • Scale-up support to DMPK and Tox studies

Route Scouting and Process Development:

  • Design and demonstration of innovative and robust synthetic routes
  • Phase appropriate process development and optimization
  • Impurity isolation, identification and synthesis
  • Design and development of scalable, robust, safe and cost-effective processes using systematic methodologies such as Design of Experiments (DoE) and Quality by Design (QbD)
  • Process optimization to identify critical process parameters (CPP) and to obtain optimum yields and high quality of products
  • Process validation studies to assure products meet specified quality parameters consistently and reliably

Process Hazard Analysis/Process Safety Assessment:

  • Identification of potential hazards such as uncontrollable exothermic reactions, explosive reactions, unexpected release of toxic or flammable gases etc., by performing careful Process Hazard Analysis/Process Safety Assessment to eliminate unsafe operations
  • Process Safety Assessment using Reaction Calorimetry (RC) and Differential Scanning Calorimetry (DSC)

Tech-Transfer and Scale-Up:

  • Modern equipment, utilities, and state-of-the-art scale-up capabilities to supply drug substance for Tox, clinical studies and commercial use
  • Seamless technology transfer from lab to pilot-plant and to commercial plant for large-scale manufacturing

Polymorph, Salt and Hydrate Screening:

  • Polymorph screening, identification and evaluation
  • Comprehensive salt, hydrate or co-crystal screening studies

Metabolite Synthesis:

  • Synthesis of metabolites and their characterization using LC-MS/ MS and NMR spectroscopy