Development activities

With the experience we have today in cell lines—upstream and downstream NMD analytical development—we support our customers as a CDMO for process development NMD, small-scale GMP (up to 10 l in microbial and mammalian) batch producer for clinical trials.

  • Cell lines & strains
  • Upstream & downstream processes
  • Analytical methods
  • Bioassays
  • Formulation development
  • Process Characterization
  • Process Validation

cGMP manufacturing

  • Master & working cell banking
  • Microbial & mammalian manufacturing of drug substance
  • Stability Studies

Quality & Regulatory

  • Commercially-proven quality system
  • Regulatory CMC support

Mammalian Cell Culture Expertise

Development capabilities

  • Proven mammalian expression
  • Transfection and generation of cell pool
  • Single-cell cloning with analytical confirmation and stability studies

Manufacturing capabilities

  • Master and Working Cell Bank generation, storage and monitoring
  • Four production lines with capacity of up to 10L
  • Option to use single- use wave bioreactor systems
  • Single Use Bioreactors
  • Pilot batches of cGMP manufacturing

Microbial Expertise

Development capabilities

  • Vector construction
  • Development of bacterial and yeast strains with stable expression
  • Clone selection and expression level verification

Manufacturing capabilities

  • Master and Working Cell Bank generation, storage and monitoring
  • Microbial line with capacity from 1L to 10L
  • Separate production facility with capacity of up to 50000L bioreactors train (operative in 2024)
  • Pilot batches of cGMP manufacturing

Analytical Expertise

Development capabilities

  • Biologics structure, identity and purity assays and characterization
  • Impurities profiling and characterization
  • Extensive analytical technologies:
    – HPLCs/UPLCs
    – Mass spectrometry
    – Octet, clEF, CE-SDS
    – N-terminal sequencing
    – RT-PCR, ELISA, etc.

Quality control capabilities

  • Product identity and purity assays
  • Process impurity assays (DNA, HCP, BE)
  • Cell based assays for potency
  • Full microbiological testing
  • Stability testing, incl. photo-stability
  • Analytical technologies
    – HPLCs/UPLCs
    – clEF, CE-SDS
    – Sub – visible particles, etc.

With new facilities in 2025, our goal is to be a leader in development processes for small-scale and production-scale biopharmaceuticals (up to 10 000l microbial and 20 000 mammalian).

Get in touch with us to know more about Celltechna


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