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Biologics Manufacturing Unit at Dharwad –Available for CMO operations

Campus 11 acre (44500 sq.m) Industrial Area in Belur, Dharwad. Zero Liquid discharge facility

Personnel Strength – 280 manufacturing staff, including Production, QA, QC, Engineering & Warehousing staff, 60 R&D staff

Biologics production facility

  • Upstream – Dual stream, Flexible, Multiproduct with Single use Fermentation (2x1000L trains being expanded to 4000Lx2 by Oct 21, with space to multiply capacity to 8000L each at short notice). Ability to run Fed batch and Perfusion modes.
  • Downstream – Flexible, with Inline Conditioning cum Chromatography hybrid units based downstream, 2-8 Deg C runs feasible. Additional space to incorporate SMB based continuous downstream
  • Filling Unit – 2nos – Multi-format filling unit (with lyophiliser) 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
  • Fully automated GMP cell banking facility, QC and Lot release labs with LIMS. All batch data stored in central eBMR
  • Central GMP warehouse - with automated racking units, RFID based tracking, Space for automated secondary and tertiary packaging units – will be integrated with SAP
  • MSAT – Separate 3500 sq ft MSAT facility with 50/200L capacity
  • Central QC Labs RM QC labs with HT HPLCs, GC, KF Titrators, Polarimeters, MP apparatus, Wet chemistry lab
  • Lot release labs with Cell based assay facility, UPLC/HPLCs with various detectors, DSC, DLS, CZE, CD, micro-osmometer, micro-pH meters, viscosity determination apparatus, Multi-mode reader, UV and Fluorescence Spectrophotometer, 2D/Gel apparatus
  • Full fledged Microbiology QC lab with sterility testing isolator, walk in BoD chambers, mycoplasma testing facility, WFI testing facility
  • Walk in stability chambers with built in redundancies - -20 Deg C, 2-8 Deg C, 20 Deg C, 30 Deg C, 40 Deg C

Microbial Production suite

  • Upstream – SS 1000L x2 nos production trains to cater to high density intensified yeast and E.coli processes
  • Downstream – GEA nozzle centrifuges, BioTree Microfiltration, diafiltration and concentration suites, GE AKTA ILC, AKTA process chromatography suites
  • Filling – Isolator based – semi-auto filling unit

Utilities

  • Vapour compression based WFI generation unit
  • Point of Use chillers, 4T +2T boilers, 3 x 750kva backup generator sets, 450 kva UPS capacities
  • 2500KVa electrical capacity, 33KVa incoming HT line
  • LN2 bullet cum transport unit
  • Rain water harvesting facility, Fully automated Kill Tanks, automated ETP with MEEs,

Current strengths and areas for collaboration

  • Screen early stage biologics leads – Biologics, Glycoproteins, Viral vectors, Plasmids produced in mammalian cells and Yeast/bacterial cells
  • Clone development to development of high productivity biologics processes/Analytical methods for transfer into Manufacturing
  • High throughput process development studies – to lower time to generate tox and clinical material.
  • Scaleup / Scaledown studies, media optimisation and clone screening studies
  • Master cell bank / working cell bank development and characterisation
  • Novel high concentration, temperature stable formulation development platform and stability studies, characterisation of product
  • Scaleup of process into GMP and production of Drug substance in GMP (CHO/HEK, Yeast, E.coli) for Clinical trials
  • Fill-Finish development capabilities integrated with Drug substance generation – infrastructure and experience in vials, PFS and cartridges – for liquid and lyophilised products
  • Regulatory filing and Quality control services to back up process development