CDMO

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

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

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

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
  – RT-PCR, ELISA
  – 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).