Home ยป Process Development
Leveraging drug development expertise to deliver cutting-edge solutions
LMS leverages our Process Development labs (PD labs) which are located at both of our manufacturing sites – Vizag and Dabhasa. The capabilities for PD Labs are at the core of our mission to manufacture affordable, high-quality pharmaceuticals.
Accelerating Innovation
Process Development is also accelerating innovations through the concept of Design Thinking at the core of any process development we touch. While we provide innovative scientific solutions to our internal and external customers, we are also committed to doing it in a safe and sustainable manner to minimize the potential impact on the environment by incorporating the 12 principles of Green Chemistry and ensure health & safety of our stakeholders. By integrating environment, health, safety, and sustainability management into an unified process development program, we strengthen the foundation for compliance, consistency and continuous improvement.
Domain Strengths
Innovation is of paramount importance and the principles of Design Thinking at our Process Development serve as guiding lights. Our PD Labs are an extension of our core R&D capabilities, located at the sites. Like the R&D labs, the PD labs have a range of domain strengths, including Route Scouting, Process Development and Analytical Development. The focus for PD labs mainly includes Cost Improvement for the APIs/ intermediates. The cost improvement is achieved by various approaches, including but not limited to alternate vendor development, yield improvement, solvent reduction/ solvent recycling, cycle time reduction, waste reduction, effluent treatability studies, etc. Apart from the cost, the lab focuses on improving the Green Chemistry metric for the processes, like PMI, RMI, E-factor, etc. This testifies to our efforts to meet business needs without compromising on environmental concerns.
Strong Development Expertise
Our PD Lab team comprises of ~50 scientists which includes both synthetic organic chemists as well as the analysts. A QbD based approach is followed for the cost improvement programs, thereby allowing us to develop robust processes with an appropriate Design Space. Applying QbD, Lean Manufacturing, and Design of Experiments (DoE) at the core of every development foster creativity that has profound impact on problem-solving and innovation. We continuously work on Life Cycle management of the legacy and commercial molecules. We integrate learning and trainings on Six Sigma Principles into the new product development to achieve Process Efficiency, Process Safety and Process Robustness during the development phase.
The analytical team at PD Labs, apart from providing the necessary analytical support, also gets involved in method development and validation as needed for the redeveloped processes. The analytical as well as the synthesis teams work towards process improvements while constantly taking guidance from the Regulatory team, so that the improvements in the processes are communicated appropriately to the relevant regulatory bodies as well as the customers.
Capabilities
Our PD Lab capabilities extend across process chemistry research, biotransformation research, macrocycles, and complex chiral molecules. A high potent lab too is available at the Vizag facility to handle molecules up to OEB 5 category. This facility again includes both Synthesis as well as the Analytical labs.
We have conducted programs that trained process development scientists on the green chemistry principles, certified Six Sigma Green & Black Belts, Data Analysis and Design of Experiment Tools, Regulatory Guidelines, which ensure that we do not focus our remediation efforts only, but rather on a proactive approach.
