Analytical services
Host cell protein analysis
The presence of HCPs and added residuals - such as enzymes - may impact the safety and efficiency of your product. We can help you identify and quantify individual process-related impurities in the downstream process. This gives you a detailed risk assessment and enables efficient elimination of these proteins.
Product characterization
Combing the product characterization with an analysis of the process-related impurities gives a more thorough understanding of your molecule. This enables optimization of the process design to ensure the drug product achieves the required safety, purity, and potency attributes.
Biologic drugs
Enables characterization of recombinant
proteins and mAbs
Advanced therapies
Helps you understand impurities in complex products like cell, gene, and bacteriophage treatments
Vaccines
Use for analysis of live attenuated or inactivated
virus and VLP-based products
The Alphalyse approach
Get personal advice
Our skilled team of mass spectrometry experts offers exceptional advice and support. By taking time to understand your needs we'll assemble a customized service package that's focused on your goals. Think of us as an extension of your team: working with you, not just for you.
Access extensive knowledge
Thanks to our ever-growing range of client projects, our protein analysis lab is constantly advancing and refining our techniques across expression systems and molecules. This means we can offer you detailed knowledge of essential product attributes and process-related residuals without you needing to invest in time-consuming training and method development.
Benefit from trusted LC-MS technology
Successful downstream optimization requires top-of-the-line instrumentation technology. Our quantitative mass spectrometry assays can help you progress faster in your development process while saving on expensive equipment.
The Alphalyse approach
Get personal advice
Our skilled team of mass spectrometry experts offer exceptional advice and support. By taking time to understand your needs we'll assemble a customized service package that's focused on your goals. Think us of as an extension of your team: working with you, not just for you.
Access extensive knowledge
Thanks to our ever-growing range of client projects we're constantly advancing and refining our techniques across expression systems and molecules. This means we can offer you detailed knowledge of essential product attributes and process-related residuals without you needing to invest in time-consuming training and method development.
Benefit from trusted LC-MS technology
Successful downstream optimization requires top-of-the-line instrumentation technology. Using our quantitative mass spectrometry assays you can progress your development process faster while saving on expensive equipment.
You are in good company
Our clients include biotech enterprises, CMOs, and pharmaceutical companies in Europe, USA, and Canada.
The Alphalyse lab provides MS-based host cell protein analysis under GMP conditions which is approved for use as a release assay.
GMP
HCP service
year's experience
MS-based HCP projects
satisfied clients
reports delivered
You are in good company
Our clients include biotech enterprises, CMOs, and pharmaceutical companies in Europe, USA, and Canada.
The Alphalyse lab provides MS-based host cell protein analysis under GMP conditions which is approved for use as a release assay.
GMP
HCP service
year's experience
MS-based HCP projects
satisfied clients
reports delivered
What clients say
John Gillard, CEO
JN Nova Pharma
Thore Schmedt, Associate Director
AiCuris Anti-infective Cures AG, Germany
Max Kristiansen, MSc, Special Consultant Assay Development
Statens Serum Institut (SSI), Denmark
Kristiina Hyvärinen, Director QC, viral products
Targovax ASA, Finland
Torben Lund-Hansen, PhD, SVP
Head of Technical Operations
Y-mAbs Therapeutics Inc., USA
Lars Skriver Senior Science Officer
SAVARA Aps, Denmark
Scott Kachlany, founder
Actinobac Biomed Inc.
Head of CMC, C> Division
GTP Bioways, France
What's new?
Quantifying HCPs: Experimental USP 1132.1 method comparison
Qualified HCP quantification for Bavarian Nordic vaccine
Article: Regulatory Consequences of New Protein-Impurity Guidelines
Webinar: Polysorbate-degrading HCPs (on-demand)
Article: Is mass spectrometry the future of impurity analysis?
USP 1132-1 and standards supporting MS-based HCP analysis
Identifying a polysorbate-degrading lipase in mAbs
Highlights from the 2024 BEBPA HCP Conference
Poster: Sensitive MS-based lipase assay for mAb products
World’s first GMP-validated MS-based residual enzyme analysis
Webinar: mAb HCP Control Strategy – Part II
Video: What is causing polysorbate degradation?
Webinars: Genmab’s Holistic HCP Control Strategy for mAbs
Video: Can your CDMO tackle Host Cell Proteins?
Blog: Why results obtained by new ELISA kit differ from the original
Exclusive Q&A: Insights from a leading CMC executive
Webinar: ELISA reagent characterization using LC-MS
Video: Rejected by the FDA → 2D gel Western blot was not enough
Insights from the BEBPA HCP Conference 2023
Webinar: LC-MS HCP assay validation and GMP release testing
Talk to us
Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.