Process Development
Sai Life Sciences delivers process development services that combine proven scientific insight, robust experimentation, and a strong focus on scalability. Our teams design and refine synthetic routes that balance efficiency, quality, sustainability, and speed—ensuring every process is ready for seamless transfer to manufacturing.
Guided by the principles of Quality by Design (QbD), Design of Experiments (DoE), and deep process understanding, we develop reproducible, scalable, and regulatory-compliant processes from gram to multi-kilogram scale. Through an integrated approach spanning route scouting, process optimization, impurity profiling, risk assessment, and scale-up planning, we accelerate development timelines while maintaining scientific rigor and process robustness.
Our Capabilities
Phase-Appropriate Process Development
Development strategies tailored to the specific stage of the program—from early feasibility and toxicology studies, where speed is critical, through late-phase optimization and commercial readiness, where process robustness, scalability, and control become increasingly important.
Route Design, Evaluation, and Optimization
Design and refinement of synthetic routes for scalability, sustainability, and time-efficient development while maintaining product quality and manufacturing feasibility.
Process Robustness Studies and DoE
Risk-based Design of Experiments (DoE) and systematic process evaluation to identify critical process parameters, establish normal operating ranges (NOR) and proven acceptable ranges (PAR), and ensure consistent process performance.
Impurity Profiling and Control Strategy
Identification, characterization, and control of process- and product-related impurities to ensure consistent product quality and regulatory readiness.
Process Safety and Hazard Evaluation
Reaction calorimetry, thermal hazard assessment, and process safety studies to support safe scale-up and compliant manufacturing operations.
Technology Transfer and Scale-Up Support
Comprehensive development documentation, scale-up support, validation support, and technology transfer packages to enable seamless transition from development to manufacturing.
Advanced Process Technologies
Application of enabling technologies such as flow chemistry, photochemistry, advanced purification approaches, and other modern process intensification strategies where appropriate.
Our Capabilities
Phase-Appropriate Process Development
Development strategies tailored to the specific stage of the program—from early feasibility and toxicology studies, where speed is critical, through late-phase optimization and commercial readiness, where process robustness, scalability, and control become increasingly important.
Route Design, Evaluation, and Optimization
Design and refinement of synthetic routes for scalability, sustainability, and time-efficient development while maintaining product quality and manufacturing feasibility.
Process Robustness Studies and DoE
Risk-based Design of Experiments (DoE) and systematic process evaluation to identify critical process parameters, establish normal operating ranges (NOR) and proven acceptable ranges (PAR), and ensure consistent process performance.
Impurity Profiling and Control Strategy
Identification, characterization, and control of process- and product-related impurities to ensure consistent product quality and regulatory readiness.
Process Safety and Hazard Evaluation
Reaction calorimetry, thermal hazard assessment, and process safety studies to support safe scale-up and compliant manufacturing operations.
Technology Transfer and Scale-Up Support
Comprehensive development documentation, scale-up support, validation support, and technology transfer packages to enable seamless transition from development to manufacturing.
Advanced Process Technologies
Application of enabling technologies such as flow chemistry, photochemistry, advanced purification approaches, and other modern process intensification strategies where appropriate.
Range of Chemistry
- Catalytic Reductions and Hydrogenation
- Advanced Cross-Coupling Chemistry
- Chiral Synthesis and Resolution Technologies
- Macrocycle and Complex Scaffold Construction
- Organometallic and Reactive Reagent Handling
- Selective Halogenation Chemistry
- Peptide Chemistry
- Advanced Functionalization Strategies
- Processes involving Highly Reactive Intermediates and More
Facilities and Technical Capabilities
Our development laboratories are equipped to support end-to-end chemistry and process development, from bench scale through pilot scale.
- High-Throughput Experimentation (HTE)
Parallel screening of solvents, catalysts, bases, and reaction conditions to accelerate route scouting, process optimization, and decision-making. - Advanced Analytical Platforms
HPLC, GC, LC-MS, and NMR capabilities enabling rapid, data-rich evaluation of reaction performance, impurity profiles, and critical process parameters. - Digital and Data Systems
Integrated data visualization platforms and electronic laboratory notebook (ELN) systems that support structured documentation, data integrity, knowledge management, and efficient technology transfer. - Process Safety and Hazard Evaluation
Dedicated reaction calorimetry and hazard-assessment capabilities to support safe process development and scale-up. - Bench-to-Pilot Scale Infrastructure
Kilo-scale reactors with precise temperature and agitation control for reliable translation of laboratory processes to manufacturing-relevant conditions.
Frequently Asked Questions
Sai Life Sciences follows a phase-appropriate development strategy designed to build scalability into the process from the earliest stages of development. Development begins with proof-of-concept and route evaluation studies, followed by process optimization supported by DoE methodologies, advanced analytical tools, and modelling and simulation platforms.
Tools such as Dynochem, MixIT, and CFD simulations are used to understand process behaviour, evaluate scale-up risks, and refine critical operating parameters. Once the process is sufficiently understood, scale-up studies are conducted in kilo laboratories and pilot facilities, where required, to replicate manufacturing-relevant conditions.
Integrated technology transfer, engineering, and operational excellence teams support the transition into commercial manufacturing, helping ensure reproducibility, process robustness, and regulatory compliance across development and production stages.
Technology transfer is managed through a structured and collaborative global framework. Teams across India, the UK, and the US work closely to ensure effective transfer of process knowledge, development learnings, and manufacturing requirements.
Simulation tools such as Dynochem, AspenOne, and MixIT are used during development to understand scale-up behaviour and support process design. Dedicated engineering and technical teams oversee pilot studies, batch execution, documentation, scale-up activities, and transfer readiness.
With more than 150 process-step transfers executed annually, Sai Life Sciences has established robust systems to support safe, efficient, and compliant global manufacturing.
Yes. Process development programs are tailored to molecular complexity, development stage, project objectives, and manufacturing requirements.
Our Process R&D teams work closely with clients to design scalable and compliant development strategies that may include route scouting, reagent screening, process optimization, impurity profiling, QbD and DoE studies, modelling and simulation, and scale-up planning.
These programs are supported by modern laboratory infrastructure, automation systems, flow chemistry platforms, advanced analytical capabilities, and specialized process development technologies.
Yes. Yield, cycle time, process efficiency, and manufacturing economics are optimized in parallel through integrated development strategies that combine DoE methodologies, process modelling, plant simulation studies, and impurity profiling.
Data generated during process optimization is used to refine synthetic routes, improve unit operations, reduce process variability, and enhance manufacturing performance. These activities are supported by scalable technology platforms and development infrastructure that enable efficient translation from laboratory development to commercial manufacturing.
Yes. Modelling and simulation are integral components of our process development approach. Tools such as Dynochem, Aspen Plus, and MixIT are used to evaluate reaction kinetics, mixing performance, heat and mass transfer, distillation behaviour, and scale-up feasibility.
These studies support process optimization, solvent swap evaluation, cycle-time estimation, and manufacturing readiness assessments. By integrating engineering expertise with simulation-driven insights, we develop robust, scalable, and reproducible processes for complex chemistries.
Resources
Pre-Clinical to Phase III API Development
Sai Life Sciences partnered with a leading U.S. Big Pharma company to optimize and scale a highly sensitive C‑terminal peptide containing six stereocenters. The objective was to enhance stage-wise yields, eliminate chromatography in the final step, and ensure high-purity API supply through late-stage clinical development.
API Development for Phase I and II Clinical Supplies
Sai Life Sciences partnered with a long-standing U.S. biotech client to optimize a complex 11‑step synthesis for a sensitive, chiral non‑natural peptide. The aim was to improve yield, streamline manufacturing, and ensure reliable API supply for early clinical studies.