Protein Analytical Characterization Services for Recombinant Protein Manufacturing
 
Alphalyse offers a range of unique protein analytical characterization services to biopharmaceutical companies and contract manufacturing organizations (CMOs). The assays can be applied to cell line development, process development, cGMP manufacturing and pharmacokinetic measurement of clinical samples.
The assays are described and illustrated with case examples in the flyer “Protein Analytical Characterization”.

The analytical methods include:

• Alpha-Quant Protein Specific Quantification Assays.
  The Alpha-Quant assays are based on isotope dilution of internal standard AQUA peptides and LC-ESI MS/MS measurements, and have a number of significant advantages over ELISA and HPLC quantification methods. The advantages include; direct and precise quantification of specific peptides in complex matrices without the need for an antibody, multiplex measurements of multiple proteins and protein variants in same analysis is possible and short assay development time in only 6-12 weeks.
  This makes the assay ideal for application in both up- and down-stream process development, quantification of multiple proteins in final formulations, and for pharmacokinetics measurement of specific protein drugs in serum samples.
• Mass spectrometry based Host Cell Protein Profiling Assay (MS HCP assay).
  The MS HCP assay is based on 1D/2D SDS PAGE and silver staining for detection of individual HCPs followed by protein identification by trypsin digestion and MALDI MS/MS peptide mapping.
  The assay provides the identity and relative quantity of each individual host cell protein and product variant. The assay is immediate applicable to all HCPs and does not need time-consuming ELISA HCP development.
  This makes the MS HCP assay ideal for application in early process development and in-process control of pre-clinical tox batches and clinical phase I/II batches. The assay is a PAT compliant approach for identification of process- and product-related impurities.
• Analytical Assays for Quality Control of Protein Expression in Cell Line Development.
  The analytical assays include services for Expression yield determination by the Alpha-Quant assay, Protein identity by MS MW determination and peptide mapping, N- and C-terminal sequencing by Edman degradation and MALDI ISD, as well as post translational modification analysis.
  

Find more information about the assays and our services at www.alphalyse.com

Or send inquiries to:
USA/Canada: Dr. Andrew Munk at munk@alphalyse.com
Europe: Dr. Ejvind Mørtz at mortz@alphalyse.com