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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Genetic Engineering & Biotechnology News | GENengnews.com | MAY 15, 2018 | 21 ical format using the weighted spectral dif- ference method (Dinh, N.N., et al. Anal. Bio- chem. 2014; 464: 60–62) incorporated into the Chirascan HOS Comparison software. This method for "spectral conversion" was recommended in a recent FDA publication, "Statistical approaches to evaluate analytical similarity—guidance for industry" (www. fda.gov/downloads/drugs/guidancecom plianceregulatoryinformation/guidances/ ucm576786.pdf). The numerical data gen- erated was used to apply the Tier 2 quality range test as recommended by the Office of Biostatistics and the Office of Biotechnology Products, CDER/FDA (Figure 3). The CD analysis was sufficiently sensitive that statistical analysis of the raw data, using ± 2 SD acceptance criteria, revealed not only statistically significant differences between the biosimilar batches and the innovator, but also differences between innovator lots man- ufactured at different geographical locations. Applying the same analytical approach to comparisons of secondary structure showed no statistically significant changes between innovator and biosimilar lots (data not shown). Conclusion CD analysis has now become a tech- nique that enables objective, statistical quantification of differences and similarities in HOS. The results generated will contrib- ute significantly to the effectiveness of com- parability programs and support informed decision-making throughout biotherapeutic development and scale-up. In addition, establishing the statistical sig- nificance of minor changes under native and stressed conditions will facilitate the defini- tion of an acceptable range for HOS vari- ability within any control strategy for safety, quality, efficacy, and manufacture. Ultimately, the ability of a new generation of CD systems to generate high-quality, sta- tistically validatable HOS comparisons will strengthen the totality of evidence required for successful regulatory submissions. Bioprocessing Tutorial High Throughput, Low Volume Subvisible Particle Analysis Subvisible particle analysis is a key predictor of protein drug stability and a key formulation, quality metric. However, current methods use large volumes of precious protein solutions and are labor- and time-intensive, making this data inaccessible during late-stage candidate screening or early in formulation. Moreover, regulatory agencies are tightly enforcing subvisible particle content in biopharma formulations at unprecedented levels, making early detection of subvisible particles, like protein aggregates, a key analytical priority. Join us for this exciting GEN webinar where we will learn how a new particle analysis instrument called Horizon employs backgrounded membrane imaging (BMI) to measure subvisible particles accurately and rapidly at low volumes. Our presenters will provide a detailed discussion of BMI, provide a thorough comparison of this methodology at low volumes with respect to flow imaging, and present a real-time demonstration of the Horizon instrument. A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists. Free Registration! www.GENengnews.com/Horizon View It Now! On Demand DURATION: 60 minutes COST: Complimentary Speakers Bernardo Cordovez, Ph.D. President Halo Labs Christopher Roberts, Ph.D. Director, Center for Biomanufacturing Science & Technology Professor, Chemical and Biomolecular Engineering University of Delaware Produced with support from Webinars

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