Description
Flexible manufacturing solutions — non GMP to commercial supply
Syngene offers flexible manufacturing solutions for small molecules. Our current good manufacturing practices (cGMP) and capabilities allow us to scale up manufacturing from laboratory volumes to commercial levels seamlessly. We follow a phase-appropriate manufacturing philosophy in our facilities, which are compliant with the regulatory guidelines. We have demonstrated capabilities and experience to manufacture batches of small molecule drug substances, advanced intermediates as well as regulatory starting materials for pre-clinical, clinical, and commercial applications at appropriate facilities, and are further expanding our capabilities to cater to growing demand from global innovators in both pharma (Human Health & Animal Health) as well as non-pharma industries.
All our scale-up activities are performed by an experienced team of chemical manufacturing personnel operating 24×7. The team is well-supported by other functions such as quality control, quality assurance, environment health safety and sustainability, engineering and maintenance, and supply chain management. Our uncompromised commitment to safety and regulatory compliance has made us trusted partners of several global customers.
Safety and regulatory compliance
Our manufacturing facilities are equipped with all necessary safety features such as rupture disc/ safety valves for all reactors and process vessels, machine guarding, zero-speed interlock, nitrogen blanketing system, flameproof equipment, and level indicators for storage tanks. We also provide anti-static clothes, packing materials, and ‘touch me pads’ to dissipate static charges.
The plants are designed to ensure compliance with all safety and quality-related regulations. A dedicated production team supported by process engineers, process safety engineers, environment and human health, safety, and security (EHSS), quality assurance (QA), and quality control (QC) teams supervise all production activities. The production team uses an SAP-enabled system to track the progress of all production-related activities from receipt of raw materials to the shop floor, including sampling to QC and the subsequent product release.
Our Bangalore facility has been audited by the United States Food and Drug Administration (USFDA), Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory bodies with a ‘NO’ observations status. The Mangalore facility is gearing up for first United States Food and Drug Administration (USFDA) expected in the calendar year 2023.
Capabilities
Chemistry capabilities
We have a proven track record of handling a wide range of complex chemical conversions at scale, using various reagents. These conversions include both modern chemistry technologies as well as conventional chemistry conversions such as asymmetric chiral inductions utilizing various asymmetric catalysis, organometallic reagents such BuLi, LDA, Grignard, Turbo Grignard etc. Metal catalyzed C-C bond formations such as Suzuki reaction, Heck reaction, Sonagashira reaction, methylation, halogenation using bromine as a catalyst, cyclopropanation, epoxidation, oxidation and hydrogenation up to 20 Barr pressure.
Process and analytical validation
Syngene is an expert in creating a straightforward strategy to perform process validation studies for intermediates, active pharmaceutical ingredients (APIs), and highly potent active pharmaceutical ingredients (HPAPIs) at the right stage of development. We design and control manufacturing processes to ensure that in-process materials and products consistently and reliably meet predetermined quality requirements.
Our scope of activities includes process control justification (PCJ) studies, failure mode and effects analysis (FMEA), analytical method validation, engineering, validation batches, and associated documentation, including all required protocols and reports. We also provide regulatory guidance in setting specifications, method development, and validation, as well as in conducting stability studies.