We offer short courses on Chemical Process Research and Development for individuals in the fields of chemistry and engineering who are seeking valuable insights into creating robust, efficient, and economical procedures for preparation of APIs, Intermedaites and speciality chemicals. The contents taught in these courses are derived from the instructor's practical experience, recent instances from the industry, and data from relevant literature. Hands-on problem-solving sessions employing real-world cases serve to reinforce the core principles of the course. This course serves as a quick start for those embarking on a career in industrial process research and development, while also providing seasoned researchers with updates and fresh perspectives.

The course may spans two days with four sessions of around 1.5 hours each and is dedicated to the research and development of chemical processes in the pharmaceutical and fine chemicals sectors.

Participants acquire valuable insights and strategies for the efficient and dependable scaling-up of processes, extending from the laboratory to the kilo lab, pilot plant, and beyond.

Hosting this short course in-house provides the advantage of tailoring the content to address specific skills and challenges unique to your company. In-house courses offer substantial cost savings, encompassing registration and travel expenses, as well as reducing the time spent away from the workplace.

Outline of Course Content

Literature Review and Route selection

•  Details Literature search,
•  Design of different ROS, feasibility studies,
•  ROS selection
•  IP management,
•  Patent infringement analysis,
•  Evaluation of RMC

Process Optimization

• Design of Experiments(DOE) and Quality by Design(QbD)
•  Optimization of reaction conditions,
•  Reagent and Solvent selection
•  Critical process parameters,
•  Identification of impurities and control
•  In-process and intermediate controls

Work-up and Isolation of Product

•  Design simple and practical work-up procedures
•  Safety considerations
•  Consideration of removal of impurities and by-products.

Crystallization and Polymorphism

• Different methods of crystallization
•  Chiral resolution
•  Different solid forms of an API – salts, co-crystals, solvates and hydrates.
•  Amorphous solids
•  Characterization of solid forms
•  Intellectual property and Regulatory issues

Process validation on Lab scale

•  Brainstorming on practical issues for process scale-up
•  Solvent recovery, reuse,
•  TTD preparation

Process scale-up and Tech Transfer

• Consideration of practical issues for process scale-up
•  Process safety, Equipment selection,
•  Cleaning and decontamination procedures.
•  Trial batches,
•  Trouble-shooting
•  Process modification with a change control,
•  Process validation on large scale.
•  Support on DMF submission and approval

Manufacturing

•  Good Manufacturing Practices (GMP)
•  Safety
•  Continual improvement
•  Stability data evaluation
•  Support on DMF submission and approval
•  Address DMF queries from customer/ regulatory authority

Interested please contact e-mail