Biofabri

Exhibitor


BIOFABRI a biopharmaceutical CDMO

Focused on Human health, which holds EU GMP certification (EMA). Biofabri is an ideal partner for any organization intending to advance their biologic product candidates from development scale to clinical Phase I to III, and commercial supplies capability.
State-of-art technology, with strong technical, development and manufacturing capabilities in VACCINES and THERAPEUTICS. Zendal group has more than 25 year of expertise in the development, validation and GMP production of Vaccines for humans and animals.
BIOFABRI is a company of ZENDAL Group (www.zendal.com). Focus on Biotechnology and is engaged in the development, manufacturing and marketing of biological and pharmaceutical products for human and animal health.
Biofabri is also collaborating on the urgent development of solutions against coronavirus disease COVID-19 through our research and manufacturing capabilities.
Your partner for BIOLOGICS manufacturing 
  • Live & Inactivated Bacteria & Viral Vaccines up to BSL-2
  • Sterile processing systems
  • Process Development / Optimisation (Upstream / Downstream)
  • Scale-up and cGMP manufacturing
  • Aseptic filling into vials
  • Lyophilization (clinical trial material and large scale)
  • Quality control testing: Microbiological: Sterility-non-sterility, Chemical-Physical and Biological
  • Labeling & packaging
  • DS & DP release
  • Storage: (+2-8ºC), (-30ºC), (-80ºC)

Manufacturing capabilities:
cGMP Production capabilities:
  • cGMP preparation and control of Master and Working Seed Lots of cells, Virus and Bacteria
  • Roller Bottles, Cell Factory & Wave bioreactor
  • Single use bioreactors: 50L + 2x250L + 2x2000L
  • Stainless Steel bioreactors: 50L +250L+ 2x2000L
  • Single use blending mixers: 2x 3000L
  • Stainless steel vessels: 4x6000L
  • State-of the art purification processes: Chromatography (ÄKTA ready), Centrifugation, Ultrafiltration, Diafiltration
cGMP fill & finish capabilities:
  • Liquid and Lyophilised products up to BSL-2
  • 4 filling machines: 6000 vials/hour - 2x12.000 vials/hour – 24.000 vials/hour
  • 2 Freeze Dryer: up to 24.000 vials per run, and up to 180.000-200.000 vials per run
  • Component size: 2R-10R-20R
  • Manual & automatic visual inspection
  • Labeling and Packaging