Author Archives: Kurt Brorson

Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance

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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidance on the testing and evaluation of viral safety of biotechnological products derived from characterized cell lines of human or animal origin through its harmonized guideline ICH Q5A (1). The latest revision, released for consultation in October 2022, maintains the key principles of previous versions while introducing key changes in response to important advances in the field. Those advances are covered in new sections that…

Triton X-100 Elimination: The Road Ahead for Viral Inactivation

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The nonionic surfactant Triton X-100 (C14H22O(C2H4O)n) is a key chemical used in ensuring the viral safety of biological medicinal products. Two pharmaceutical sectors share an extensive historical background with it: biopharmaceuticals and plasma-derived products, for which it is used to inactivate lipid-enveloped viruses. Recently, environmental regulations in the European Union have encouraged or mandated a phase-out of this surfactant (1). The goal of the ruling is to protect aquatic ecosystems from potential Triton X-100 degradation products that can function as…

December 12, 2022

Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships

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A CMC Strategy Forum held in Washington, DC, on Sunday 28 January 2007 focused on two topics related to protein structure and function (1). First, analytical techniques used in the glycan analysis characterization included recent advances and correlations among the various tools. And second, current understanding of glycosylation’s functional relevance to therapeutic proteins was discussed in the context of its effects on biological activity, pharmacokinetics, and Fc effector functions (for monoclonal antibodies, MAbs). Progress has been made in the field…

September 23, 2015

Glycosylation of Therapeutic Proteins

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    ACMC Strategy Forum held in Washington, DC, on Sunday 28 January 2007, focused on two topics related to protein structure and function. First, analytical techniques used in the glycan analysis characterization included recent advances and correlations among the various tools. And second, current understanding glycosylation’s functional relevance to therapeutic proteins was discussed in the context of its effects on biological activity, pharmacokinetics, and Fc effector functions (for monoclonal antibodies, MAbs). Progress has been made in the field of…

June 1, 2011