Eurofins CDMO leverages a wealth of experience in process chemistry. Our dedicated team is committed to delivering innovative and efficient solutions tailored to your unique needs from early-phase development to commercial manufacturing.

Our approach

eurofins-cdmo_img-1073

Integrated process development expertise

Our multidisciplinary team combines synthetic organic chemistry, process chemistry, analytical sciences and solid-state expertise to solve complex development challenges.

Expand_img

Our capabilities

  • Route scouting, design and optimisation 
  • Process optimisation and demonstration
  • Impurity marker (process related impurities, GTIs, nitrosamines etc) and reference standard synthesis
  • Full structure elucidation and characterisation
  • Physicochemical characterisation, crystallisation engineering, and polymorph studies
  • Analytical method development, qualification, and validation
  • Stress testing and ICH-compliant stability studies
  • CMC gap analysis and commercialisation readiness
eurofins-cdmo_img-1098

Advanced capabilities

We leverage specialised technologies, including continuous flow chemistry, to overcome synthetic challenges and enhance safety and efficiency.

Expand_img

Continuous flow capabilities & platforms

  • Reaction Plate
  • Plug Flow
  • MSMPR
  • CSTR 

Chromatographic separation techniques

  • Reverse phase and normal phase
  • Medium pressure chromatography (Biotage, Buchi)
    • Bench scale - 10 g- 1.5 kg columns
    • Kilo scale - 5 kg - 40 kg columns
  • High pressure chromatography
    • Prep-LC - up to 4 inch columns
    • Prep-SFC 
  • Lyophillisation 

Automated laboratory reactors

Process safety assessment

eurofins-cdmo_img-1054

Phase-appropriate development

We provide flexible development programmes tailored to your stage. Our teams are experienced in accelerated pathways, helping you reduce timelines while maintaining quality and compliance.

Expand_img
  • Preclinical through Phase I–III development
  • Phase II process redevelopment to resolve scale-up challenges
  • Late-stage optimisation and lifecycle management
  • Fast Track, Breakthrough, and Orphan drug programme support
  • Full CMC and regulatory support, including authoring
alphora-plan

Seamless scale-up & manufacturing

Our FDA- and Health Canada-audited facilities provide flexible scale-up from laboratory to commercial production.

Expand_img

Scale capabilities

  • Kilo Lab: small scale glassware and up to 50 L reactors
  • Pilot Plant: multiple 200 L, 500 L and 2000 L reactors 
  • Batch sizes ranging from grams to >100 kg 

Additional capabilities include:

  • High-pressure and temperature reactions
  • Advanced drying and isolation systems
  • Chromatography purification (g to multi kilo scale)
  • Dedicated high-potency suites (Safebridge Class 4)
eurofins-cdmo_img-0982

High potency capability

Our high potent experts make scale-up from laboratory to pilot and commercial production simpler and tailored to your programme.

Expand_img

Non-GMP R&D high potency capabilities

  • Rigid Isolator Containment, Bag-in-Bag out Technology
  • Scale-up to 3L reactor
  • Biotage, Prep Chromatography
  • Air Monitoring/Surrogate Testing

GMP R&D high potency capabilities

  • Rigid Isolator Containment, Bag-in-Bag out Technology
  • Up to ~5kg single batch 
  • Biotage, Prep Chromatography
  • Air Monitoring/Surrogate Testing
eurofins_26june_063

Expert team

Our team is the foundation of our success. We provide every project with dedicated support from a cross-functional group of experts who bring deep experience in overcoming complex process development challenges across the biopharmaceutical industry.

Clients rely on our technical strength to execute phase-appropriate development and redevelopment programmes, resolve issues, optimise processes, and advance existing assets toward successful scale-up and commercialisation.

Expand_img

Core areas of expertise

  • Synthetic organic chemistry
  • Process chemistry and development
  • Analytical sciences
  • Solid-state chemistry
  • Process safety and risk assessment
  • Chromatography and purification
  • NMR and structural characterisation

Fast track, breakthrough, orphan programmes

Significant experience in commercialising FDA-designated Fast Track, Breakthrough and Orphan therapeutics, leveraging the experience and resources of the full organisation (development, CMC regulation, manufacturing) to quickly advance programmes from phase I to commercial launch.