Facility design and capacity
The Process Development laboratory will have bioreactors of 2-10L capacity with associated purification equipment. The manufacturing facility will have multiple single-use bioreactors of up to 2KL capacity. The facility is designed to ramp up manufacturing capacities to more than 20 KL with a maximum bioreactor scale of 5 KL. It will provide GMP manufacturing from 2L to 2 KL in the initial phase and ramping up to 5 KL. The manufacturing facility will be handling products with titers <1g/L to 12 g/L using a single-use platform for easy, flexible, and efficient multi-product operations.
- The facility will develop and manufacture biologics on high-performing cell culture platforms.
- Support the development to manufacturing of formulated drug substances including the generation and long-term storage of MCB/WCB.
- Manage platforms like fed-batch, continuous and intensified processes for high throughput production for upstream and downstream processes at clinical to commercial scale.
- Continuous chromatography system and single-use membrane chromatography, as an alternative to resin-based purification, towards cost and throughput optimization.
3D Layout Purification-1 & Purification-2
Quality Management System (QMS)
- Compliant with global regulatory requirements like ICH Q7, PMDA, EMA, PIC/S and US FDA guidelines.
- Aligned to concepts laid down in ISPE baseline guides for Biopharmaceuticals.
- Aragen’s corporate QMS is implemented at its US-FDA approved API manufacturing facilities..
- Support virtual person-in-plant and remote virtual audits.
Process control & Digitization
- Building management system to control the clean room parameters like temperature, relative humidity (RH), and differential pressure.
- Centralized process control and data acquisition system to integrate all the process equipment, temperature control equipment and clean room equipment on a centralized server towards generation of reports and trends.
- Remote monitoring and data logging of storage cabinets and incubator parameters and automated alert systems towards continued compliance.
- Process control, centralized process control and data acquisition system to integrate all the process equipment, temperature control equipment and clean room equipment on a centralized server towards generation of reports and trends.
- Platform for integration to SAP, MES, e-BMR and e-Log (phase wise) towards paperless operations.
- PAT implementation like RAMAN and online variable path spectroscopy for establishment of predictive models and digital twins.
- Paperless operation for quality assurance, warehouse, and maintenance operation through eQMS, eDMS, LIMS, e-LMS, WMS and SAP for asset management driving preventive maintenance and calibration.
- This facility will facilitate regulatory support to clients seeking solutions like biosimilarity assessment, continuous process verification, resin recycling, process characterization studies, stability studies, and forced degradation studies etc.
- Regularity support may be extended throughout the product life cycle including IND/IMPD and BLA/MAA as per CTD module 2 & 3 and variation filings.