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Rapidly scaling & validating manufacturing processes to enable timely supply in a cost–effective manner
LMS has a strong track record of successfully transferring technology into its two manufacturing facilities at Dabhasa and Visakhapatnam, and rapidly scaling & validating manufacturing processes to enable timely supply in a cost-effective manner.
Process and Analytical Methodologies
Process and analytical methodologies are transferred into a dedicated, on-site team for demonstration on laboratory scale, including analytical method demonstration and validation by the Quality Control function. Environment, Health and Safety Assessments, including process safety studies are undertaken as a basis for definition of the full-scale manufacturing process which is defined in reviewed and approved batch records. Operators are thoroughly trained in execution of batch records and the compliance of the manufacturing process within the site’s Quality Management System.
Flexible Manufacturing
- Scalable production capacities from lab-scale to commercial-scale.
- State of the art Kilo Lab having intermediate area and Pharma Area.
Technology Transfer
- Seamless transfer of processes from development to commercial-scale manufacturing.
- Experienced to handle various chemistry like: Organic, Inorganic Physical, Green, Bio, Analytical, and Stereo Chemistry.
Process Optimization
- Expertise in optimizing processes for scale-up, including process validation and qualification using various techniques of statistical process control, design of experiments and process modelling.
Regulatory compliance
- Adherence to global regulatory standards including cGMP, FDA and EMA guidelines.
State-of-the-Art Equipment
- Advanced equipment for various unit operations, including mixing, reducing particle size and lyophilization.
Advanced Analytical Techniques
- Specialized analytical equipment including HPLC, GC, XRD, ICPMS, LCMS, GCMS, AAS, BET Analyzer.
