The MPDD (Management and Professional Development Department) is an important component of Interpharma Praha, a.s. (IPP). In 1992, when IPP re-entered the market as a private and independent company, the research and development activities were focused on X-ray contrast media, cytostatic compounds and specialty food supplements (nutraceuticals) based on naturally occurring substances. Since 2008, when IPP became part of the Japanese pharmaceutical group Otsuka Pharmaceutical Company, Ltd., the MPDD participates in the development of substances for corporately developed and produced original formulations in addition to the above named areas.
The integral parts of MPDD are analytical laboratory (floor area 700 m2) and a state of the art pilot plant. The pilot plant contains a clean room (cleanliness class C) for final operations. The pilot plant can accommodate the majority of typical chemical synthetic processes at temperatures ranging from –40°C to 150°C and pressures from 50 bar to 20 bar.
Our development activities are supported with in-house analytical techniques, including HPLC, UPLC, LCMS, GC, GC/MS.
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 experienced in the application and optimization of existing manufacturing processes, as well as in the development of new synthetic routes.
Our Primary areas of focus for Process Development Include
- 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
Key Processes Developed in our Management and Professional Development Department
- High-pressure catalytic hydrogenation in volumes from milliliters to 1500 liters
- Halogenation of aromatic compounds; mainly iodination or aromatic systems
- 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