Alphalyse

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Alphalyse has pioneered the use of mass spectrometry analysis since 2002. Our scientists have completed over 5,000 protein characterization analyses, including forced degradation studies and over 400 LC-MS-based residual/host cell protein projects. Currently, we are the only CRO in the World certified to offer LC-MS-based MRM analysis under GMP for release testing. 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. Our services include analytical characterization of biopharmaceuticals, mass spectrometric peptide mapping, host cell protein analysis, and quantifying specific proteins in complex samples.

Company Details

Employees
37
Founded
-
Address
Roedegaardsvej,
Phone
45 63106500
Email
in****@****yse.com
Industry
Biotechnology Research
NAICS
Research and Development in Biotechnology (except Nanobiotechnology)
HQ
Odense, DK
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Fidelio Capital partners with Alphalyse to accelerate the global roll-out of LC-MS host cell protein analytics - News-Medical

Fidelio Capital partners with Alphalyse to accelerate the global roll-out of LC-MS host cell protein analytics News-Medical

Regulatory Consequences of New Protein-Impurity Guidelines - BioProcess International

Regulatory Consequences of New Protein-Impurity Guidelines BioProcess International

Host cell protein quantitation by LC-MS. Experimental demonstration, qualification, and comparison of methods in USP 1132.1 - ScienceDirect.com

Host cell protein quantitation by LC-MS. Experimental demonstration, qualification, and comparison of methods in USP 1132.1 ScienceDirect.com

Denmark: Fidelio Capital partners with Alphalyse to accelerate global roll-out of LC-MS host cell protein analytics - Investors in Healthcare

Denmark: Fidelio Capital partners with Alphalyse to accelerate global roll-out of LC-MS host cell protein analytics Investors in Healthcare

New mass spectrometry Chapter could “revolutionise” biopharma quality assurance - European Pharmaceutical Review

New mass spectrometry Chapter could “revolutionise” biopharma quality assurance European Pharmaceutical Review

Beyond ELISA: Is Mass Spectrometry the Future of Impurity Analysis? - BioProcess International

Beyond ELISA: Is Mass Spectrometry the Future of Impurity Analysis? BioProcess International

A Smarter Way To Remove Host Cell Protein Contamination From Gene Therapies - Technology Networks

A Smarter Way To Remove Host Cell Protein Contamination From Gene Therapies Technology Networks

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