Process R&D and cGMAP Manufacturing

Process R&D and cGMAP Manufacturing

Mascot has state-of-the-art infrastructure spreading across 90 acres and having 1,000,000 sq. ft. of working space. Our laboratories have dedicated areas including approximately 500,000 sq ft of Chemistry & Biology laboratories, cGMP Kilo Lab, Bio-manufacturing Facilities, Animal Facility and Formulation Development Centre.

We are located at GIDC area Ahmedabad

Mascot strives to attract and retain the best talent in the industry and back them up with world class infrastructure and systems. All the laboratories are equipped with high-end instruments and equipment to support the various research and development activities. We have some of the best equipment in the lab, an excellent IT and communication system and an experienced team.

We also have well established systems to maintain data confidentiality while working with multiple clients and have an impeccable track record over the last 19+ years. We have a comprehensive business continuity and disaster recovery plan. We have an established governance model implemented to successfully manage multiple client relationships. The governance structure varies based on the size and scope of the collaboration.

Process R&D and cGMP Manufacturing

Mascot has comprehensive Process R&D (PRD) and cGMP manufacturing capabilities to support the CMC campaigns of NCE programs. Our PRD facilities inlcude Syrris Atlas automated reactor system and Filtration study equipment.

Process Research and Development

Mascot’s process research and development team comprises of chemists, engineers and process analysts with expertise in every phase of process research.

Some of the key equipments we have are listed below:
Syrris Atlas automated reactor system
Radley’s carousel system
Glass reactors, 100mL to 20L
Process engineering lab
Laboratory distillation set up: Regular and packed columns
QVF all glass reactors: 5L to 20L
Flow process equipment
Filtration study equipment
Hazard Evaluation: RC1e; DSC & TGA

cGMP Manufacturing

Mascot’s cGMP manufacturing facility is spread across 60,000 sq. ft. We have over 36 reactors ranging from 20L to 3000 L having capacities in SS 316 L, glass lined, Hastelloy. We are equipped with Automated systems like Building Management System (BMS) and Distributed Control System (DCS) to manage facilities. Our cGMP manufacturing facilities are designed with multiple clean rooms with separate wet & dry processing areas of which 4 are class 100,000 (ISO-7) and 1 is class 10,000 (ISO-8).

High Pressure Reactions: We have capabilities to operate up to the pressure of 40 kg/cm² which includes the high end gas induction type of hydrogenator. In addition, we have capabilities to undertake acidic hydrogenation reactions.

Crayogenic Reaction: We have diverse capabilities with multiple crayogenic reactors ranging from 20L to 1500L capable of achieving temperature up to (-) 100ºC.

Mascot has capabilities for freeze drying up to (-) 55ºC by using tray type lyophilizer in a classified area.