"Create superior biologics and therapies through better analytics"

Our mass spectrometry services help you optimize the CMC process and monitor product and process-related proteins.

"Create superior biologics and therapies through better analytics"

Our mass spectrometry services help you optimize the CMC process and monitor product and process-related proteins.

Analytical services

Protein analysis

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.

host cell protein

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 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.

Experts on HCP analysis
Knowledge on mass spectrometry

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. Using our quantitative mass spectrometry assays you can progress your development process faster while saving on expensive equipment.

SWATH LC-MS analysis

The Alphalyse approach

Experts on HCP analysis

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.

Knowledge on mass spectrometry

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.

SWATH LC-MS analysis

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.

Alphalyse is GMP certified CRO

GMP

HCP service

20 years experience
+

year's experience

400 MS-based HCP projects
+

MS-based HCP projects

500 satisfied clients
+

satisfied clients

5000 mass spectrometry reports
+

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.

Alphalyse is GMP certified CRO

GMP

HCP service

20 years experience
+

year's experience

400 MS-based HCP projects
+

MS-based HCP projects

500 satisfied clients
+

satisfied clients

5000 mass spectrometry reports
+

reports delivered

What clients say

JN Nova Pharma logo
"Alphalyse provided structural identification and characterization of a process HCP impurity in our biologic that was otherwise difficult to identify and the knowledge permitted us to modify a DSP to monitor and control it"John Gillard, CEOJN Nova Pharma
Aicuris logo
"Alphalyse provided a very well-designed and executed HCP analysis, fruitful technical discussions, and flexibility in terms of writing the report."

Thore Schmedt, Associate Director
AiCuris Anti-infective Cures AG, Germany
SSI logo
"Alphalyse's HCP analysis saved us the development of an ELISA assay that may not have worked anyway. The HCP team explained test results competently and was very open to discussing the method capabilities."

Max Kristiansen, MSc, Special Consultant Assay Development
Statens Serum Institut (SSI), Denmark
Targovax logo
"They handled the project professionally and rapidly, and the report was very well written, clearly explaining the findings."

Kristiina Hyvärinen, Director QC, viral products
Targovax ASA, Finland
Y-mAbs logo
"We enjoy collaborating with Alphalyse as part of our optimization of manufacturing processes. Not only do we gain access to their hands, but we also get to pick their brains for mass spectrometry knowledge."

Torben Lund-Hansen, PhD, SVP
Head of Technical Operations

Y-mAbs Therapeutics Inc., USA
Savara logo
"Using the Alphalyse LC-MS/MS coverage method in HCP ELISA selection, we estimate a savings of approximately $1M and, likely, one year of development time."

Lars Skriver
Senior Science Officer

SAVARA Aps, Denmark
Actinobac Biomed Inc logo
"The FDA approved our IND! They accepted the MS data without also requesting the standard HCP-ELISA immunoassay."

Scott Kachlany, founder
Actinobac Biomed Inc.
GTP Bioways logo
"We are very pleased with the work of Alphalyse because they provide us with a high-quality antibody characterization service. Most importantly, we can ship them hundreds of samples at once and always receive the analytic results shortly after. "

Head of CMC, C&GT Division
GTP Bioways, France

What's new?

HCP database

Webinar: Exclusive preview of the Alphalyse HCP database

Get an exclusive view of how you can use HCP-MS data from our 500 client projects
Identifying a polysorbate-degrading lipase in mAbs

Identifying a polysorbate-degrading lipase in mAbs

Lipases co-purifying with mAb products can degrade polysorbate even at trace levels
Hightlights from the 2024 BEBPA HCP Conference.

Highlights from the 2024 BEBPA HCP Conference

What's new? The latest on HCP analysis by MS from the 2024 BEBPA HCP Conference.
Investigate polysorbate degrading HCPs

Poster: Sensitive MS-based lipase assay for mAb products

Sensitive MS-based MRM assay to detect polysorbate-degrading HCPs in mAb products
Case-24: Polysorbate degradation caused by LPL (lipoprotein lipase)

Video: What is causing polysorbate degradation?

When LPL affects the efficacy and safety of your drug product
Senior CMC managers Søren Skov Jensen and Margarita Sabater from Genmab

Webinars: Genmab’s Holistic HCP Control Strategy for mAbs

Genmab will present how to select the most appropriate release testing method
CDMO could not identify the cause of unstable mAb product

Video: Can your CDMO tackle Host Cell Proteins?

A mAb drug showed poor stability over time and the CDMO could not identify the cause
A photo of an Alphalyse employee filling an ELISA plate with sample material.

Blog: Why results obtained by new ELISA kit differ from the original

Bridging from one HCP-ELISA kit to another, even just a new version, is not as straightforward as it sounds
Live Q&A with Bryant McLaughlin CMC Executive

Exclusive Q&A: Insights from a leading CMC executive

Insights on MS-based Host Cell Protein analysis from a leading CMC executive with experience in process optimization and IND documentation
Analytics for advanced therapies

Webinar: ELISA reagent characterization using LC-MS

Get a detailed understanding & documentation of the HCP-ELISA reagents' suitability to the specific manufacturing process
PLBL2 coverage documentation

Video: Rejected by the FDA → 2D gel Western blot was not enough

Our client's impurity risk assessment was not satisfactory to the FDA.
BEBPA HCP conference 2023

Insights from the BEBPA HCP Conference 2023

Ejvind Mørtz and Rikke Lund summarize insights from the BEBPA HCP conference 2023, Get the latest news on current trends.
Analytics for advanced therapies

Webinar: LC-MS HCP assay validation and GMP release testing

An MS-based assay is ideal when the complexity of a therapeutic makes it challenging to find an adequate ELISA
USP chapter 1132.1

BREAKING: New USP general chapter on HCP analysis by MS

The new US Pharmacopeia general chapter on ID and quantitation of HCP using MS is now available for public comments
Evaluating five commercial HCP-ELISAs kits

Selecting the best HCP-ELISA kit out of five

Antibody therapeutics developer: "We found the kit with best coverage of HCPs overall and individual HCPs of concern"
1st MS-based HCP analysis release test applied to COVID-19 candidate

1st MS-based HCP analysis release test applied to COVID-19 candidate

Alphalyse and Bavarian Nordic significantly shorten the time necessary to document HCP impurities before Phase 3 clinical trial
Vaccine HCP analysis

Webinar: Analyzing vaccine purity – without an HCP ELISA

Learn how to quickly measure & compare residual protein in any type of vaccine
HCP coverage analysis on uncommon expression system

HCP-ELISA coverage analysis without a null cell line

Developer of immuno-oncology biologics: "Thanks to the data, we knew which HCP-ELISA kit to use!"
Comparing viral protein quantities in AAV-based products

Comparing viral protein quantities in AAV batches and DS

Gene therapy CMO: "We could compare and document batch consistency and locate any differences in AAV products"
forced degradation study

Stability study – an important part of biologics license application

Our client needed a stability study of protein degradation products for regulatory documentation

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.

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