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Bioprocess Development

Veeda Biopharma’s Bioprocess Development team specializes in the development of therapeutic and non therapeutic proteins using microbial (E. coli) and mammalian (CHO; HEK) expression systems. We focus on creating high-yield, stable clones with comprehensive traceability throughout the process. Starting at the microbioreactor level, we scale up production in 5 L bioreactors with the capability to expand to a 50 L single use bioreactor, strictly adhering to GMP and GLP standards

Precision in Every Step: Advanced Process Development Solutions

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Microbial Protein Production and Clone Development

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  • Protein purification and characterization
  • Cloning and expression of recombinant heterologous proteins
  • Host cell characterization

Protein purification and characterization

Cloning and expression of recombinant heterologous proteins

Host cell characterization

Your Partner for Mammalian Protein Expression & Cell Line Development

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  • Gene synthesis [codon optimization]
  • Expression construct preparation
  • Lipofection/electroporation
  • Stable pool generation
  • Stable pool evaluation

  • Single cell dispensing
  • Single cell imaging
  • Monoclonality establishment
  • Titer evaluation

  • Purity
  • Sterility
  • Stability

  • Evaluation of top/lead clones
  • Growth and expansion
  • Banking (RCB)

Integrated Expertise: Analytical CMC in Every Step of Cell line and Process Development

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Cell Line/Clone Selection

  • Protein sequence verification
  • Sequence variants characterization
  • Post-translational modification(PTM) analysis
  • Glycosylation analysis
  • De novo sequencing

Upstream

  • Harvest Titers
  • Identity
  • Purity
  • Glycosylation analysis
  • Post-Translational Modification Analysis

Downstream

  • Size and charge variants
  • Refolding efficiency
  • Identity
  • Purity
  • Heterogeneity
  • Impurity characterization
  • N-/O-glycans
  • Residuals
  • Potency

Mastering Every Stage: End-to-End Process Development Expertise

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Process Development & Optimization (100-150ML)

  • Bioreactor suitability
  • Media/feed screening
  • Feeding strategy
  • Process parameters

Process Scale-up at 2L/5L Scalevest

  • Feeding strategies
  • Aeration strategies
  • pH
  • Material generation

Harvest Clarification

  • Centrifugation
  • Filtration

Downstream Process

  • Affinity chromatography
  • Ion-exchange chromatography
  • Size exclusion chromatography
  • Hydrophobic interaction chromatography
  • Filtration
  • Concentration