* End to end CDMO solution having all inhouse capabilities, starting from clone development to commercial manufacturing & supply of biological products.
* Quick development of process and supply of Microbial and Mammalian based recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies and ADCs from milligram to gram scale.
* Development, qualification and validation of analytical methods, characterization methods, method transfer, comparability, biosimilarity and sameness studies.
* Experience in developing robust manufacturing processes, either fed batch or perfusion based, multiple biosimilars & fusion proteins.
* Successfully optimized and validated the processes for many projects like a Copper Binding Peptide (NBE), Human Insulin, Sputnik V and ZycoviD Bulk Covid Vaccine etc. for different customers.
* Manpower – ~240 manufacturing staff, including Production, QA, QC, Engineering & Warehousing staff, 60 R&D staff
* Production -
* Mammalian Upstream – Two independent streams, Single Use Fermentation (2x2000L, 3x1000L, 6x200L, 2x50L) systems – scope for expansion to 16kL.
* Microbial Upstream – SS Fermenters (3x55000L, 2x30000L, 2x3000L, 2x1000L, 2X200L, 2x20L)
* Downstream – Flexible, with AKTA Inline Conditioning Buffer generation unit and AKTA Chromatography units based downstream. Additional space to incorporate SMB based continuous downstream
* Filling Unit – 2nos – Multi-format filling unit (with lyophilizer) in Isolator from Snowbell Inc and Filling line from AST Inc, USA–for RTU PFS and vials
* Secondary and tertiary packaging facility from IMA-PG – for PFS, vials and DDCs
* GMP cell banking facility, QC and Lot release labs
* Central GMP warehouse - with automated racking units, RFID based tracking, Space for automated secondary and tertiary packaging units – will be integrated with SAP.
