Alphalyse offers a broad range of analytical assays to Biopharmaceutical companies and Contract Manufacturing Organizations (CMOs) to improve knowledge about the protein and the development process in the following areas:

• Cell line development 
  • Screen for a cell line and clone with high protein expression, with the correct molecular weight, amino acid sequence and post translational modifications
    
    
• Fermentation
  
  • Optimize fermentation conditions and improve protein yields using absolute protein quantification assays
    
    
• Down stream process development
  • In process control assays for protein identity, purity and quantity
  • Optimize protein yields for each process step and determine process mass balance using absolute protein quantification assays
    
    
• Mass spectrometry Host Cell Protein assay (HCP assay) 
  • Establish HCP contaminant profile at different process steps as well as for individual drug substance batches for toxicology studies and clinical trials
    
    
• Stability Assays
  • Protein identity assays and characterization of protein degradation products
    
    
• Analytical characterization of recombinant proteins, drug substance or formulated drug product
  • Protein characterization and analysis of product related variants
  • Mw determination, peptide mapping, Edman sequencing, post translational modifications, i.e., glycosylation, disulfide bonds, oxidation, deamidatation, carbamylation, truncations, sequence variations etc.

Your goal is our goal.
To ensure this we undertake discussions with you to define common objectives from the outset. We appoint a project manager who is the principal contact and responsible for all planning and communication issues. Following discussions we develop a proposal, which includes the project deliverables, the budget and timelines.

Enquire for project proposal and quotation