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Manufacturing
Manufacturing
Mavens operates a cutting-edge production facility that includes a cGMP pilot plant, an intermediate area, and ISO class 8 (Class 100,000) clean rooms. It has good infrastructure with reactors with capacities ranging from 0.16 to 4 KL and a total capacity of 50 KL. We help businesses scale up quickly while adhering to non-GMP and cGMP guidelines.
Our team aids clients with drug substance supply for clinical trials and commercial manufacture, in addition to supporting early-stage programmes such as IND-enabling projects. We want to be your one-stop shop for bench-scale to commercial-scale production services.
- Advanced Intermediates and NCEs/APIs Manufacturing Suits that are flexible and adaptable.
- Preclinical/Tox Studies cGMP Manufacturing of Intermediates/NCEs/APIs on a fast track from lab to kilo lab.
- From the pilot to the manufacturing plant, a technology transfer protocol has been established.
- As part of a Business Continuity Plan, strategic outsourcing and backward integration of SM/KRMs are required.
- Mechanical Vapor Recompression Effluent Treatment Plant with ZLD (Zero Liquid Discharge).
- Quality & On Time In Full (QOTIF) delivery.
Facility Highlights:
- 8906 square metres in size, with a built-up area of 7845.43 square metres.
- Reactors with capacities ranging from 20 to 4000 litres and a variety of materials of construction (MoC) including stainless steel, glass lined, all glass, and halar coated.
- Dedicated production space for corrosive processes such as bromination and chlorination, among others.
- Four ISO Class 8 clean rooms for the isolation of drug substances ranging in weight from a few grammes to hundreds of kilogrammes.
- All modules have a powder processing section with a multi miller, vibro sifter, and micronizer.
- Hydrogenation plant with reactors ranging from 0.25 to 2 kL.
- 100-200kg batch size (single batch – depending on dilutions).
- Thermic fluid heater, chilled water, chilled brine, hot oil, and liquid N2 are all available to manage reactions between -780 and +2000 degrees Celsius.
- Nutsche Filter coated with fibre glass reinforced plastic (FRP) and Halar. RCVD, SS, and GL are Roto Cone Vacuum Driers.
- Lyophilizer on a small scale.
Warehouse Facility:
- Raw materials, packing materials, and rejected materials all have their own storage areas.
- Store materials at 2 to 8 °C and -20 °C in walk-in coolers and deepfreezes.
- Raw materials have their own sample and dispensing room.
- Hazardous materials and activated charcoals are stored in a separate room.
- Temperatures of 25°C, 2°C, and -20°C are maintained in a dedicated finished goods storage facility.