Our approach
Alphalyse has pioneered the use of mass spectrometry analysis since 2002. Our scientists have completed over 10,000 protein characterization analyses, including forced degradation studies and more than 650 LC-MS-based residual/host cell protein projects.
As a specialist contract research organization (CRO), we offer protein analysis services to support biopharmaceutical companies in developing and manufacturing patient-safe products such as mAbs, vaccines, recombinant proteins, and cell & gene therapies.
You can count on us to work closely with you on developing well-characterized biologics by challenging and improving analysis methods using top-of-the-line mass spectrometry technology (LC-MS). Our comprehensive reports will allow you to carry out data-driven process development and regulatory documentation under ICH Q6B guidelines.
What sets us apart
Personal guidance from planning to execution and follow-up
We aim to become an extension of your team and take pride in building strong and rewarding relationships. We are as passionate about helping to develop a safe and effective therapy as you are.
Expert knowledge and top-of-the-line technology
Our project leaders are PhD graduates, and many came the University of Southern Denmark, renowned for its research on mass spectrometry. We partner with leading instrument companies to ensure that we have access to the newest technology.
Experience with most types of biologics
We continue to advance and refine our techniques based on an ever-growing range of client projects across expression systems and molecules. To date, we have performed more than 5,000 characterization analyses for more than 500 clients worldwide.
An agile organization that can quickly adjust to your specific needs
Are you working to solve a unique challenge? Our team can help you address a wide variety of problems related to drug development. All of our services were developed and improved upon in cooperation with clients – and we would be excited to help you too.
What sets us apart
Personal guidance from planning to execution and follow-up
We aim to become an extension of your team and take pride in building strong and rewarding relationships. We are as passionate about helping to develop a safe and effective therapy as you are.
Expert knowledge and top-of-the-line technology
Our project leaders are PhD graduates, and many came the University of Southern Denmark, renowned for its research on mass spectrometry. We partner with leading instrument companies to ensure that we have access to the newest technology.
Experience with most types of biologics
We continue to advance and refine our techniques based on an ever-growing range of client projects across expression systems and molecules. To date, we have performed more than 5,000 characterization analyses for more than 500 clients worldwide.
An agile organization that can quickly adjust to your specific needs
Are you working to solve a unique challenge? Our team can help you address a wide variety of problems related to drug development. All of our services were developed and improved upon in cooperation with clients – and we would be excited to help you too.
Why rely on us
Certainty
We understand that complete confidence in your product quality and integrity is crucial. Protein analysis service is our core business, and we can help you unlock the knowledge necessary to move your project forward confidently and quickly.
Capability
LC-MS can give a more profound perspective to anticipate the potential consequences of residual proteins. We help find the right solution to your analytical challenges from project kick-off to final report.
Progress
As a leading-edge company using top-of-the-line technologies, we can create the competitive advantages you need to succeed.
How we work
We customize every project to fit our client’s specific needs.
In collaboration with you, we will:
Facilitate meetings to review the project scope and finalize the project proposal
Appoint an experienced, PhD level project leader to your project to ensure timely delivery, fulfill the project objectives, and keep your team updated on progress
Provide reproducible data using advanced instruments and robust workflows, with SOPs in place for all processes to ensure the highest quality
Follow up the report with an online meeting to review the results and answer your questions
News and inspiration
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
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.