Author Archives: Blaž Goričar

Next-Generation Software Solutions for Analytical Chromatography Processes

High-performance liquid chromatography (HPLC) has become a leading analytical method for biopharmaceutical process development and optimization, particularly for therapies that leverage plasmid DNA (pDNA), messenger RNA (mRNA), and viral vectors. In July 2022, Blaž Goričar (manager of process analytics development at BIA Separations, a Sartorius company) demonstrated the features of his company’s PATfix software for HPLC data processing and analytics. He described how the program can simplify method execution and enhance evaluation of resulting data. Goričar’s Presentation PATfix software is…

Streamlining Industrial Purification of Adeno-Associated Virus

With its first licensed therapeutic now marketed worldwide (1), adeno-associated virus (AAV) has become a preferred vector for gene therapy. However, unlocking its full potential still poses challenges, many of which are associated with purification. The first involves the transition from upstream to downstream processes. AAV-bearing lysates are laden with debris that foul filtration media and limit or prevent concentration. Another challenge involves reduction of soluble host-cell DNA, which is complicated by its strong association with nucleoproteins. A third involves…

A New Runway for Purification of Messenger RNA

A high-performing capture method is a critical bedrock asset for developing industrial purification processes. This is especially true for extended families of products that share highly similar chemical composition. Therapeutic monoclonal IgG is an example. The ability of protein A affinity chromatography to achieve 95% purity in one simple step was the runway that got recombinant immunotherapy off the ground and made it available to millions. In fact, protein A did more. Beyond giving the industry a foundation manufacturing method,…