September 2022

Twenty Years of Innovation: Reflections on the Industry’s Past and Future

In honor of BPI‚Äôs 20th anniversary as a publication, the editors invited authors to reflect on the industry‚Äôs past, present, and future. Below, the chief operating officer of Selexis offers her perspectives along with responses to questions from the editorial team. Significant Scientific and Technological Innovations One of the most important innovations in bioprocessing has been the combination of next-generation sequencing with bioinformatics. The ability to sequence a host cell-line genome and transcriptome rapidly and cost-effectively and the development of…

Comprehensive Virus Clearance Evaluation Using Microscale Membrane Adsorbers

Membrane adsorbers can be a simple and effective choice for anion-exchange (AEX) purification of biopharmaceuticals. However, as Sherri Dolan (global technology consultant for virus clearance at Sartorius) explained during a May 2022 presentation, biomanufacturers generally do not leverage their membranes‚Äô full loading capacities. Doing so could improve process economics and decrease costs for several downstream applications. Dolan‚Äôs Presentation Membrane adsorbers are ideal for flow-through AEX applications (e.g., secondary purification and polishing) because they can be used at high flow rates…

Analytical Tools for Improving Up- and Downstream AAV Process Development

During a May 2022 Ask the Expert presentation, Ivana Petrovińá Koshmak (head of upstream process development at BIA Separations, part of Sartorius) highlighted the gene- therapy industry‚Äôs need for fast, reliable analytics that work with both up- and downstream samples. High-performance liquid chromatography (HPLC) methods can fulfill that need, but process development (PD) scientists would need to account for the complexity of bioreactor samples to make such methods feasible for end-to-end analytics. Koshmak described a novel instrument that is designed…

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, BlaŇĺ Gorińćar (manager of process analytics development at BIA Separations, a Sartorius company) demonstrated the features of his company‚Äôs PATfix software for HPLC data processing and analytics. He described how the program can simplify method execution and enhance evaluation of resulting data. Gorińćar‚Äôs Presentation PATfix software is…

Leveraging Prior Knowledge to Demonstrate Analytical Competency

Analytical groups are developing more methods than ever to address mounting demand for biopharmaceuticals. Still, such teams need to work within tight timelines to help candidate therapies advance quickly through clinical trials. During a May 2022 presentation, Rajgopal Rudrarapu (senior scientist at the Almac Group) pointed out that regulatory agencies allow biomanufacturers to apply prior knowledge to facilitate analytical development and validation. He described how his company leveraged prior knowledge to develop and validate a capillary isoelectric focusing (cIEF) method…

Bringing Gene-Therapy Product Quality Into Focus

Regulatory agencies are scrutinizing gene-therapy product quality more closely than ever, yet such therapies still are produced in small batches and at high costs. Thus, drug companies are struggling to make safe and efficacious gene therapies available to patients. In an April 2022 presentation, Tim Kelly (chief executive officer of Oxford Biomedica Solutions, OXB Solutions) emphasized the importance of addressing both process output and product quality when manufacturing adenoassociated virus (AAV)-based gene therapies. Such an approach requires deep expertise and…

A Tool for Rapid, Accurate Concentration Measurement of Biological Samples

Conventional ultraviolet‚Äďvisible spectroscopy (UV-vis) instruments use fixed optical pathlengths to measure analyte concentrations in biological samples. As Paul Mania (bioanalytics application specialist at Repligen) pointed out during an April 2022 presentation, such an approach requires sample dilution, which introduces risks for error and increases operator workload. Mania explained how the CTech SoloVPE instrument measures analyte concentrations at line without need for dilution, simplifying and accelerating analysis of samples from several downstream operations. Mania‚Äôs Presentation Traditional UV-vis instruments measure analyte absorbance…

Improving Viral Vector Manufacturing: Modeling Costs to Help Optimize Processes

Manufacturing costs remain high for gene therapies delivered by adenoassociated virus (AAV) vectors. The biopharmaceutical industry must minimize such expenses because they account for significant proportions of the high prices that patients pay for treatment. During a June 2022 webinar, Emmanuelle Cameau (leader for cell and gene therapy strategic technology partnerships at Pall Corporation) joined Maxime Dumont (cell and gene therapy product manager at webcast sponsor Polyplus-transfection) to describe their companies‚Äô efforts to model AAV manufacturing costs. Cameau and Dumont…

Using Cutting-Edge Tools to Optimize Cell-Culture Media Development

Although culture-media optimization accounts for a relatively small part of process development, selections made at that stage strongly influence overall bioprocess productivity. Yaron Silberberg (chief scientist at the Ajinomoto Genexine CELLiST Solution Center) joined BPI in July 2022 to present strategies for enhancing media performance. He focused on how emerging tools for statistical analysis and process control facilitate media development for cultures based on Chinese hamster ovary (CHO) cell lines. Silberberg‚Äôs Presentation Because materials applied during cell-line development are not…

Mass Photometric Analysis of Adenoassociated Virus Capsids

Current production processes for gene therapies based on adenoassociated virus (AAV) vectors generate many empty capsids. That problem complicates vector purification and diminishes product safety and quality. In a June 2022 webinar, Gareth Rogers (product manager at Refeyn Ltd.) observed that developers could benefit significantly from analytical instruments that assess empty-to-full (E:F) capsid ratios rapidly. He explained how the SamuxMP mass photometry system (Photo 1) could address such needs. Kirsty McManus (senior scientist in AAV characterization at Pharmaron Gene Therapy)…