ICH Q6B and EMA set out the regulatory guidelines for the physicochemical and structural characterisation of biopharmaceuticals, which includes a determination of the composition, physical properties and primary structure of the desired product.

To gain regulatory approval, significant analytical data is required to confirm that the biopharmaceutical product has the appropriate quality, safety, efficacy and comparability.

RSSL provides a comprehensive service to support you in ensuring the identity, purity, stability and quality of your biopharmaceutical products.

• Forced degradation studies
• GMP release testing
• Biosimilar characterisation
• Stability studies
• Glycosylation analysis
• Process & product related impurities
• Host cell dna and protein
• Protein, peptide and glycoprotein analysis
• Extractables and leachables
  
• Method development and validation
  
• Microbiology analysis
• Sub-visible particle analysis
• Problem solving and contaminant identification
• Training