FIS R&D: structure and organization model
• Develop safe, economical, robust and scalable processes for manufacture of APIs and pharmaceutical intermediates.
• Focus on supplying the customer with a competitive advantage, whether the product is a new API or a generic drug.
• Continue process optimization during the entire product life cycle.
• Confidentiality agreement.
• Integrated project management from feasibility study.
• Consolidated project reporting experience from the initial lab assessment to pilot and commercial process implementation. All data is shared openly with the customer.
• In-house resources and tools for safety and optimization studies.
• In-house resources for deep literature search and patent analysis.
• Access to major database from scientific (i.e. STN, SciFinder, Reaxys) and commercial purposes (i.e. IMS and Thomson Reuters Newport and Forecast).
• Relationships with external contract laboratories for toxicity and flammability testing of isolated intermediates and APIs for safe handling and storage, if required.
The R&D staff is comprised of 61 people:
• 12 project leaders with chemistry degrees
• 2 Project Managers
• 23 lab technicians working in two 8h shifts per day
• 1 literature and intellectual property intelligence expert
• 3 assistants for documentation and activity records
• 18 pilot plant operators, working in 3 shifts per day (24h/day)
• Management and pilot plant operators.
• The 12 project leaders are organized in 6 different units, with 5 resources each. Every unit typically handles 3 - 4 projects per year. The projects can vary from early process development and route exploration to multi-kilo production.
• FIS Project leaders carried out 2704 experimental trials in 2010 for 210 different chemical transformations and 120 various isolation steps
FIS’ R&D lab activity has increased 70-75% from 2007, growing at an average rate of 25% every year.
The group has 35 different projects currently ongoing:
• 17 for generic API applications
• 18 for custom manufacturing