Accelerated Process Development: Role of Engineering Data Generation

Jegadeesh Thampi, vice president and head of Chemical Development at Syngene International, will discuss the significance of engineering data generation in a pharma insight briefing on Oct. 11, 2018 at CPhI Worldwide in Madrid, Spain.

According to Syngene, the biggest challenge from a contract manufacturing organization’s perspective is to develop processes which are robust, scalable, and reproducible across manufacturing environments and achieve right first-time. Developing a method for any process to achieve first-time successful scale-up requires adequate data collection within the phase-appropriate development philosophy. The decisions made throughout the process development need thorough assessment supported by data to avoid surprises on scale.

“The most important success factors are the type and extent of data collection at each phase of development,” according to the CPhI Worldwide agenda listing. “It could be a reaction kinetics or a unit operation such as distillation, crystallization, or drying; or it could be an elaborate impurity purging study or DoE [design of experiment] study to define parameter boundary or developing a transfer function.”

The company reports that it has acquired significant expertise in generating engineering data at each phase of drug-substance development supported with models and simulation, enabling it to demonstrate seamless scalability and control over the processes compared to conventional approaches.

Thampi has over 16 years of R&D experience with chemicals, catalysis, and API/new chemical entities (NCEs). In his current role at Syngene, he is responsible for the development and manufacture of investigational API/NCEs, performance and specialty materials, and therapeutic oligonucleotides.

The presentation will take place at 11:50am–12:20pm, CPhI Theatre, Hall 9, stand 9C80.

Source: CPhI