Key Features :

• Design of Experiments (DoE): Using a Design of Experiments (DoE) approach, we identify the Critical Process Parameters (CPPs) that impact yield, purity, and scalability. We conduct a series of controlled experiments to refine and optimize the process conditions.

• Impurity Profiling: Detailed characterization and quantification of process- and degradation-related impurities to ensure compliance with regulatory specifications.

• Fate and Purge Studies: Systematic evaluation of impurity carryover and clearance across unit operations to establish effective control strategies.

• GTI and Nitrosamines Assessment: Risk-based identification, assessment, and control of genotoxic impurities and nitrosamines in line with ICH and regulatory guidelines.

• Yield Enhancement: Our team applies innovative optimization techniques to enhance the overall yield of the compound while maintaining or improving purity and quality. This ensures that the process is not only efficient but also sustainable.

• Green Chemistry Approaches: We integrate green chemistry principles to minimize waste, improve atom economy, and reduce energy consumption, ensuring that the process is environmentally friendly and sustainable.

• Scalability and Robustness: By leveraging our multi-scale manufacturing capabilities, we ensure that the process is robust and scalable, able to transition smoothly from lab-scale to pilot-scale and ultimately to commercial manufacturing.

• Process Safety and Compliance: We prioritize safety at every stage of optimization by conducting thorough process safety studies, ensuring that our processes meet the highest regulatory and safety standards.

• Real-Time Process Monitoring: We utilize advanced process monitoring techniques to continuously track the critical parameters during optimization. This data helps us quickly identify any issues and make timely adjustments to improve the overall process.

• Reaction Kinetic Studies: Systematic investigation of reaction rate profiles and mechanistic pathways using time-course sampling and advanced analytical tools (e.g., HPLC, LC-MS) to determine rate-limiting steps, activation energies, and order of reaction. These studies enable optimization of critical process parameters (CPPs), control strategies, and reaction conditions under varying temperature, concentration, and solvent systems. Kinetic modeling supports data-driven scale-up, enhances reaction robustness, and aligns with QbD principles for regulatory filing and technology transfer.

Key Benefits :

• Reproducibility : Consistency in yield and quality across every batch, along with production-friendly operations to ensure ease of execution for shop floor production executives.

• Efficiency and Cost Reduction : By optimizing each stage of the process, we reduce production costs while maintaining or improving product quality.

• Scalability : Our optimized processes are designed to be easily scalable from lab-scale to commercial-scale manufacturing, ensuring a smooth transition at every stage.

• Regulatory Compliance : Our team ensures that every process is in full compliance with GMP and regulatory requirements, setting the foundation for successful clinical trials and commercialization.

SCALE UP STUDIES LAB

12

Reactors

5L - 100L

Reactors range

cGMP Scale up laboratory for small-scale projects Synthesis & Supply of cGMP/non-GMP material for clinical studies(Grams to kilograms level) & Data generation

KILO LAB

30

Reactors

5KL

Reactors range

cGMP kilo-lab for small-scale projects (up to 10kg) : Synthesis & Supply of cGMP/non-GMP material for clinical studies(Grams to kilograms level) & Data generation