Press Release: CovalX is now offering expanded analytical characterization services for biotherapeutic proteins focusing on investigational new drug applications in accordance with ICH Q6B guidelines. (prweb.com)
ZURICH AND MARTILLAC, FRANCE AND SAUGUS, MASS. (PRWEB) FEBRUARY 09, 2023
CovalX announces the expansion of its CRO analytical capabilities to offer additional services that include analytical characterization services for investigational new drug (IND) applications to the FDA, EMeA, and similar agencies according to the ICH Q6B guidelines for biotherapeutic protein characterization. CovalX has long been established as a leader of mass spectrometry analytics services for biotherapeutics, most notably monoclonal antibody characterization. These additional services build upon this existing knowledge base, offering a more thorough analytics portfolio in the characterization of these novel biologic products.
The International Council for Harmonisation (ICH) recommends the ICH Q6B guidelines for test procedures and acceptance criteria of biological products being submitted to the FDA for IND filings. These guidelines outline the physicochemical characterization, binding, biological activity, quantity, and purity of a biological product. The ICH Q6B guidelines have been accepted as standard practice by the FDA, EMeA, Japanese JPMA and many other regulatory agencies for incorporating best scientific practices into the pharmaceutical regulatory process. These guidelines describe a physicochemical characterization program which will generally include composition determination, physical properties, and structure of the therapeutic protein.
Fulfilling these guidelines requires numerous analytical technologies and methodologies for complete implementation. CovalX has already specialized in the mass spectrometry services needed to accomplish many of these guidelines. With this announcement, CovalX will also be offering several non-mass spectrometry based analytical approaches that are needed for full ICH Q6B adherence. Thus, these approaches together provide the most thorough analytical characterization possible for a biological product.
CovalX has headquarters in Zürich, Switzerland; a North American subsidiary in Saugus, MA; and a French subsidiary located in Martillac, France. CovalX is a technology and CRO market leader in the field of biotherapeutic and biotherapeutic interaction analysis by mass spectrometry. CovalX offers a unique instrumental solution and complete range of analytical services for the characterization of novel biotherapeutics to its worldwide customer base.