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What we do Biologics GMP Manufacturing

GMP Manufacturing

A modern biologics manufacturing facility is coming up in Bangalore, India as part of Aragen’s integration strategy of “Gene to GMP” solutions. The facility will be equipped for intensified processing using single-use bioreactors and advanced downstream purification capabilities to serve our global customers.Robust quality control, quality assurance, environment health safety and sustainability, engineering and maintenance, and supply chain management complete our “Gene to GMP” strategy.

Infrastructure

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.

Advanced technologies

  • 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.

Regulatory support

  • 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.

Learn more about our end-
to-end capabilities

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