Manufacturing compounds at scale in a state-of-the-art cGMP facility
Syngene’s exclusive current good manufacturing practices (cGMP) and chemical manufacturing capabilities allow us to scale manufacturing from benchtop volume to commercial levels. We follow a phase-appropriate chemical manufacturing philosophy in our facilities, which are compliant with regulatory guidelines. We have demonstrated capabilities and experience to manufacture batches of compounds for pre-clinical, clinical, and commercial applications at appropriate facilities, and are further expanding our capabilities to cater to growing demand.
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.
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 asymmetric catalysis, Suzuki reaction, Heck reaction, Sonagashira reaction, methylation, halogenation using bromine as a catalyst, Grignard reaction, cyclopropanation, epoxidation, and oxidation.
Process and analytical validation
Syngene is well-versed 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.
Infrastructure
Located in Bangalore, Syngene’s dedicated state-of-the-art cGMP manufacturing facility supports the development and production of small molecules. Since inception, we have successfully supplied APIs, advanced intermediates, and new chemical entities (NCE) for molecules in the early and late phases of drug development, as well as for commercial use.
Our facility includes equipment of various capacities and materials of construction operating over a wide range of temperatures. We can produce an output from grams to hundreds of kilograms per batch, having generated around 184 tons of materials for various projects since 2015.
We have a dedicated HPAPI cGMP manufacturing facility to handle cytotoxic and cytostatic high potent compounds up to 0.1 µg/m³-8h OEL. The facility includes multiple reactors and downstream equipment, which are housed in standard isolators, to support up to 20 kilograms/ batch.
Our team of highly qualified and experienced technicians operate the facilities in compliance with all safety and regulatory requirements. With a strong emphasis on maintaining quality as well as ensuring the safety of man and material at every stage, all the necessary support functions such as environment, health, and safety (EHS), and maintenance are available on-site.
State-of-the-art equipment
Our manufacturing plant has different ISO Class 8 certified clean rooms that are segregated into wet and dry processing areas. The wet processing area includes various-sized reactors made of glass, SS314, and Hastelloy, that are controlled through a validated distributed control system (DCS). It also has various Nutsche filters, centrifuges, sparkler filters, and dryers. The dry processing area handles all powder processing and is equipped with the necessary drying, milling, sifting, and packing equipment.
Our facility can handle both dry and wet milling operations, reducing particle size to as low as 5µ. We have different dryer equipment such as vacuum tray dryers, rotary cone vacuum dryers, and spray dryers. Our milling units include multi mill, pin mill, and wet mill units.
We perform both normal-phase and reverse-phase high-performance liquid chromatography (HPLC) purification and separation using Novasep and other chromatographic systems (SS316L and glass columns) in a classified area. We handle cryogenic reactions with temperatures as low as -100°C using different scales and reactors made of SS316L and Hastelloy. Our hydrogenation reactions are also performed in a classified zone to meet various process conditions.
Safety and regulatory compliance
Our manufacturing plant is 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 plant is 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 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.
