Genetic Engineering & Biotechnology News

MAY15 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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18 | MAY 15, 2018 | | Genetic Engineering & Biotechnology News tion (TFF) cassettes, hollow-fiber filters, and prepacked columns have driven flexibility and efficiency in multiuse facilities. These advanc- es enable reduced setup, cleaning, and change- over times associated with the manufacture of biologics. In addition, recombinant Protein A affinity resins have undergone dramatic improvements: novel ligands, a two-fold in- crease in dynamic binding capacity, and en- hanced flow properties. These improvements have significantly increased the productivity of capture chromatography. Dr. O'Donnell: A significant advance in downstream pro- cessing occurred when the patent for Protein A expired. A plethora of low-cost alternatives are available, some with even better capacity, caustic stability, and adsorption kinetics than the original. Although the adoption of multicolumn continuous chromatography is slow, most manufacturers and chromatography vendors are invested in this technology. Only time will tell how many columns in series will be the optimal for more efficient purifications. Disposables are much more common now than they have ever been, including single-use (or more aptly single-campaign) prepacked chromatography columns. GEN: Which technologies or methods are best suited to the detection, characterization, and control of impurities in biologic products? Dr. Bulpin: The basic principles of characterization testing of source material followed by batch release testing apply to all manufacturing process, in- cluding next-generation processing. Advanc- ing molecular tools such as next-generation sequencing (NGS) and polymerase chain reac- tion (PCR) are now primed to replace lengthy conventional cell-based assays. Molecular assays offer the sensitivity and detection range required to confirm a prod- uct's purity, and they can be performed in days as opposed to weeks, making release testing performed in real time a reality. The industry-wide question of "What is a batch?" can be circumvented by designing multiple test points in a process based on a well- thought-out risk assessment strategy. Dr. Levison: Most recently, we have seen immunoassay technologies that deliver more specific, selective, and sensitive assay results. For example, bio-layer interferometry applies optical analytical techniques to measure bio- molecular interactions in real time. Develop- ments in at-line laser capture microdissection technology has enabled the characterization of product-related impurities using LC–MS. Multivariate data analysis has also gained popularity due to its ability to deliver multi- attribute monitoring and identify process perturbations in real time. Through the Danaher Life Sciences net- work, Pall Biotech is uniquely positioned with access to the most advanced de- tection, character- ization, and control technologies via the Beckman Coul- ter Life Sciences, Pall (including Pall ForteBio), and Sci- ex portfolios. Ms. Gebski: The control of product- and nonproduct-re- lated impurities in biologic products needs to go as far back as the cell culture process. Fed- batch cell culture processes can starve cells of key nutrients, accumulate deleterious by- products, and allow cell viability to plummet to less than 80% at harvest. Such changes in culture conditions can impact protein qual- ity and drive impurities into the purification process. By contrast, perfusion cell culture with XCell™ ATF allows a culture to main- tain consistent nutrient availability and sus- tain high cell viability over the entire course of the culture. A consistent cell culture condi- tion drives fewer impurities into the down- stream process. Dr. O'Donnell: Implementation of inline or even online higher order detection methods with real- time analysis enhances the identification and quantitation of impurities. These methods could include multiangle light scattering and Fourier-transform infrared spectroscopy. The acceptance of sub-2-micron chroma- tography particles in liquid chromatography ( L C ) a n d l i q u i d chromatography– mass spectrometry (LC–MS) analysis enables rapid and almost limitless characterization of impurities. How- ever, limitless iden- Roundup Continued from page 16 Bioprocessing J. Kevin O'Donnell, Ph.D. Process Chromatography Support Manager Tosoh Bioscience Peter Levison, Ph.D. Executive Director Business Development Pall Biotech Mind the Transcripts: Visualizing RNA Expression and Variants within the Brain For many years, DNA and protein were the only game in town when it came to tools for tissue diagnostics. Moreover, due to the complexity of some methods and lack of sensitivity for others, RNA in situ hybridization (ISH) was often overlooked as a viable analytical tool. Now, in the age of genomics, a novel technique and probe design combined with advanced signal amplification and background suppression, enables the detection of target RNAs, RNA mutations, exon junctions, splice variants, non-coding RNA, circular RNA, or gene fusions at the single-cell level. This advance in RNA analysis provides investigators with a prominent level of diagnostic versatility that is useful across the research spectrum: from basic science research to advance drug discovery applications. Join us for this fascinating GEN webinar, where we will learn how the RNAscope® ISH method was utilized to identify unique mRNA splice variants of brain-derived neurotrophic factor (Bdnf ), to investigate their biological significance in brain function and behavior. Additionally, we will hear how RNAscope can be utilized to detect challenging antibody targets and visualize them within their morphological context. A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists. Free Registration! View It Now! On Demand DURATION: 60 minutes COST: Complimentary Speakers Kristen Maynard, Ph.D. Postdoctoral Fellow Lieber Institute for Brain Development Johns Hopkins Medical Campus Annelies Laeremans, Ph.D. . Research Scientist Advanced Cell Diagnostics Produced with support from Webinars

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