OUR GMP BIOMANUFACTURING SERVICES

High-quality biologics production with proven regulatory compliance and scalability

At Biodextris, we transform your ideas into real-world solutions through our expertise in GMP  and non-GMP production. From early discovery to clinical trial material, our flexible services ensure biomolecules of the highest quality, ready to meet industry standards.

Our Biomanufacturing Capabilities

  • Protein and bio molecule production from milligrams to tens of grams per batch
  • A versatile platform supporting multiple applications

Market segment

  • Human health
  • Animal health

Platform

  • Microbial
  • Mammalian
  • Plant-based cells
  • Insect cells

Products

Recombinant Proteins:

  • Antibodies (monoclonal, bispecific, trispecific)
  • Fusion proteins
  • Cross-linked proteins
  • Toxins (BSL2)
  • Antigens (protein antigens)
  • VLPs (virus-like particles protein-based)
  • Enzymes

Other biologics (Not recombinant proteins):

  • Whole-cell (bacterial) vaccines
  • Subunit (bacterial) vaccines 
  • AAV (adeno-associated virus) 
  • Lentivirus 
  • Plasmids

Why Choose Biodextris?

  • GMP Compliance

Established QMS, verified batch records, 6,500 sq. ft. (600m²) of GMP-compliant BSL2 clean rooms

  • Proven Expertise

Dozens of biologic products produced for preclinical, clinical and diagnostic programs worldwide.

  • Flexibility

Production in both GMP and non- GMP environments

  • Integrated Support

Product characterization packages available

Our GMP Services

  • CELL BANKING

    • Stable pools or clone bank (animal cells)
    • Master and working cell banks (animal and microbial)
    • Comprehensive cell bank characterization

  • UPSTREAM PRODUCTION

    • Bioreactors capacity from 5 to 200L
    • Mammalian cell culture (CHO, HEK and more)
    • Microbial fermentation
    • Batch and fed-batch processes
    • Recombinant and native proteins
    • Whole-cell therapeutics
    • BL2 containment

  • DOWNSTREAM PRODUCTION

    • Depth filtration
    • AKTA Pilot and AKTA Ready chromatography systems
    • Ion exchange, affinity, multi-mode & size exclusion chromatography
    • Semi-automated TFF
    • Ultrafiltration/Diafiltration
    • Buffer exchange
    • Viral clearance
    • Formulation
    • Small scale aseptic Fill & Finish for vials and PFS

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GET IN TOUCH WITH OUR FRIENDLY TEAM

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