Create superior biologics and therapies through better analytics

Our mass spectrometry services can 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 can 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 call 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-in-your-corner
access-extensive-knowledge-blue

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.

Trusted-LC-MS-Expertise

The Alphalyse approach

Experts-in-your-corner

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-blue

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.

Trusted-LC-MS-Expertise

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.

We provide MS-based HCP analysis under GMP conditions which is approved for use as a release assay.

gmp-ribbon-blue

GMP

HCP service

20-+-years’-experience-blue
+

year's experience

300-+-ms-based-hcp-projects-blue
+

MS-based HCP projects

500-+-satisfied-clients-blue
+

satisfied clients

5000-+-reports-delivered-blue
+

reports delivered

You are in good company

Our clients include biotech enterprises, CMOs, and pharmaceutical companies in Europe, USA, and Canada.

We provide MS-based HCP analysis under GMP conditions which is approved for use as a release assay.

gmp-ribbon-blue

GMP

HCP service

20-+-years’-experience-blue
+

year's experience

300-+-ms-based-hcp-projects-blue
+

MS-based HCP projects

500-+-satisfied-clients-blue
+

satisfied clients

5000-+-reports-delivered-blue
+

reports delivered

What clients say

"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
"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
"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
"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
"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
"The FDA approved our IND! They accepted the MS data without also requesting the standard
HCP-ELISA immunoassay."

Scott Kachlany, founder
Actinobac Biomed Inc.
"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

Need inspiration?

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

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"

Video: ICH Q8B characterization of complex products

The complexity of VLP-based vaccines makes characterizing them challenging

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

Webinar: Analyzing vaccine purity – without an HCP ELISA

Learn how to quickly measure & compare residual protein in any type of vaccine

Summary of BEBPA’s Host Cell Protein Conference 2022

We have summarized the key topics and take‐home message for you
process webinar

Webinar: #Rethink your HCP strategy

Monitor HCP clearance for expression systems without access to an ELISA kit

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!"

Quantifying lentivirus and residual proteins in one assay

UK C&GT division: "We can now monitor the consistency of our viral capsid formations in lentivirus-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"
2021 gtp webinar

Webinar: Monitoring impurities and ensure consistent therapies

Quickly identify and quantify all proteins in complex products using only one assay
mab webinar

Webinar: Why do we need orthogonal HCP analysis for mAbs?

How to investigate your mAb for potentially problematic HCPs < 1ppm
case study native digest lod mab

Revealing HCPs not detected by ELISA in antibody-drug product

mAb developer: "We combine ELISA and LC-MS to avoid having any HCP impurity surprises in Phase 2 or 3"
purified mab hcp

Purified mAb with difficult-to-remove HCP impurity (ubiquitin)

CMC Director: "The analysis' level of detail enables risk assessment of Host Cell Proteins in our mAb DS."

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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