Production - INTERPHARMA PRAHA, a.s.

Contract Process Development

Manufacturing Process Development

At Interpharma Praha, a.s. (IPP), we apply our broad knowledge and long-term experience in process development of pharmaceutical manufacturing processes for our own substances as well as for our contract manufacturing clients. Our chemists are very experienced in the application and optimization of existing manufacturing processes, as well as in the development of new synthetic routes.

Primary Areas of Process Development

  • Proposal and design of perspective industrial synthetic routes
  • Process transfer from laboratory to pilot plant and commercial scale
  • Process optimization
  • Determination of critical process parameters
  • Identification, isolation and synthesis of process and potential impurities
  • Development of analytical methods
  • Investigation of physical and chemical properties of substances with respect to their future formulation into final dosage forms
  • Cost analysis and cost reduction as a part of the process life cycle management
Synthesis

Key Processes Developed in our R&D Department

  • High-pressure catalytic hydrogenation in volumes from milliliters to 1500 liters
  • Column purification - development and scale up
  • Membrane separation filtration processes (reverse osmosis, nanofiltration and microfiltration) - design, development and scale up
  • Spray drying - design, development and scale up
  • Crystallization and product isolation processes - optimization of purity, increased yields and cost-effective formulation

Contract Manufacturing

IPP can provide contract manufacturing services in GMP certified manufacturing units:

  • multipurpose full-scale modern unit for API production (batch sizes up to 300 kg)
  • multipurpose low volume unit (batch sizes up to 10 kg)

IPP also offers a full range of services in the development of industrial manufacturing processes, primarily for the production of APIs and intermediates.

Details on contract manufacturing capabilities and development services are included in the Contract Manufacturing brochure