• Process Development

Process Development for APIs and Intermediates

What We Offer

  • Synthetic process development and optimization
  • Process validation and technology transfer
  • API synthesis for toxicological batches and IND submission
  • GMP manufacturing for clinical studies

Why Partner With ChemExpress

  • Effectively reduce cost of goods (CoG) through process optimization
  • Fast delivery of toxicology batches to meet challenging timelines
  • Experienced in impurity control strategy, including impurity ID, preparation, and analytical method development
  • Experts in potential genotoxic impurity (PGI) control, from in silico screening to analytical method development and validation
  • Familiar with the regulatory environment and requirements in the USA, EU, China, and Japan as we have to date successfully assisted clients in completing 100+ US-China dual IND filings

Key Technologies

Formulation Development

What We Can offer

  • Preformulation Research
    • API solubility in different media and solvents
    • Characteristic dissolution of API
    • Accelerated stability studies under different conditions
    • Solid state analysis ( polymorph, particle size, particle shape, etc. )
  • Formulation Development
    • Formulation development of new chemical entities (NCEs)
    • Formulation and process development based on QbD concepts
    • Development of new dosage forms
    • Process scale-up and technology transfer
    • Analytical method development and stability studies
    • Lifecycle management

Why Partner With ChemExpress

  • Formulation CMC
  • cGMP clinical sample preparations
  • Commercial drug product manufacturing for MAH
  • Solubility-enhancing technology for amorphous solid dispersions (Spray drying, hot melt extrusion, fluidized bed)
  • Controlled release technology eg. pellet-coating
  • Lyophilization technology
  • Semi-solid vacuum emulsification and homogenization technology
  • Orally disintegrating tablet and sublingual tablet technology

Key Technologies

Formulation Facilities

Oral Solids Workshops

  • Tablets
    1 billion tablets/year
  • Capsules
    500 million capsules/year
  • Granules
  • Powder
    • Jet mill
    • Dry granulator
    • Wet granulator
    • Oven
    • Fluidized bed ( Wurster coater)
    • Spray dryer
    • Hot melt extrusion
    • Tablet press machine
    • Coating machine
    • Granular horizontal packaging machine
    • Aluminum plastic packaging machine (aluminum plastic, hard aluminum)
    • Particle dispenser
    • Capsule filling machine
  • Spray Dried Dispersion
  • Fluidized bed
  • Coating machine
  • Dry granulator
  • Granular horizontal packaging machine

Semi-Solid Workshops

  • Gel
    40 million tubes/year
  • Cream
  • Ointment
    • Vacuum homogenizing emulsifier 30~160L
    • Vacuum homogenizing emulsifier 15~25L
    • Vacuum homogenizing emulsifier 0.25-30L
    • Filling and sealing machine 2000~4000 units/hour
    • Vacuum homogenizing emulsifier 500~1000L
  • Vacuum homogenizing emulsifier 30~160L
  • Filling and sealing machine
  • Vacuum homogenizing emulsifier