Process Development

DIVERCHIM has a proven track record of achievement with companies, no matter of size, from pharmaceutical, biotechnology, cosmetic and agro-chemical industries which entrust us with their new products. Our experienced team manage customer’s projects in a dynamic and transparent way. Partnering with DIVERCHIM enables our customers to retain full control over their projects with access to a wide range of industrial expertise and technologies. 

PROCESS DEVELOPMENT

This activity is complementary of the custom synthesis activity. It involves developing a process of synthesis for a specific molecule in view of a future industrialization.

Often, the initial synthetic route designed for the synthesis of the “Drug Candidate” is inappropriate for large scale manufacturing. Thus, chemical process research is conducted to identify a synthetic process that is:

• Robust and Reproducible
• Quick
• Transferable
• Cost-effective
• Safe
• Sustainable and Environmental friendly

The main steps of this phase are:

• Route assessment : route design and selection
• Process optimization
• Scale-up
• Identification and synthesis of byproducts
• Synthesis of metabolites
• Synthesis of cold compounds : D, ¹³C, ¹⁵N, ¹⁸O

SUPPORT FOR PRECLINICAL AND CLINICAL PROGRAMS

DIVERCHIM is able to provide its customers with the first batch of the drug candidate from milligram to kilogram scale under: non cGMP (Good Manufacturing Practice) and cGMP conditions (audited by customers) for pre-clinical studies. Quality Assurance department has been set-up since 2011 to complete the work of our Quality Control Department and develop the syntheses under cGMP conditions.

Our integrated approach and expertise in chemical process development add value to our customers’ activities by decreasing development time from discovery to market.
 

ANALYTICAL DEVELOPMENT

• Support for non cGMP and cGMP synthesis projects (including in process control)
• Analytical method development and validation

REGULATORY AFFAIRS AND SUPPORT

• Preparation of Investigational Medical Product Dossier (IMPD), Drug Master File (DMF)
• Support for patent deposit

DIVERCHIM ensures complete confidentiality and technology transfer in case of exclusive methodology development.

OUR EQUIPMENT

• Doubled jacketed glass reactors (6 - 50 L, -100 °C to +180 °C)
• Pressure reactor under ATEX environment (2 – 7,5 L up to 200 Psi)
• Photochemical reactor (0,6 – 20 L, 500 – 1,000 W)
• Ozonolysis reactor (10 g/h O_3, Handle 100 – 150 g batches)
• Short path distillation KDL5
• 25 L cryogenic reactor with liquid nitrogen serpentine
• cGMP pilot unit (2014) 2 x 250 L reactors (glass lined and stainless steel)