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| Webinar: Adapting to Evolving Regulations: Validation in a Changing Landscape | Join a roundtable with Kneat experts to explore evolving regulatory expectations in the life sciences industry. Learn about key regulatory requirements, the shift to risk-based approaches like Computer Software Assurance (CSA), and how digital validation can improve compliance, efficiency, and audit readiness. Gain actionable insights and strategies for navigating Pharma 5.0. Click here to learn more. |
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By Business Of Biotech | This episode of the Business of Biotech finds Matt Pillar and Ben Comer exploring the evolution of gene therapy with Dr. Tom Chalberg, Founder, Chairman, and CEO at Genascence. Listen in as they discuss ATMPS' transition from treating rare diseases to addressing common conditions like osteoarthritis, share insights on the delivery mechanism and regulatory challenges in the space, and get into the nuts and bolts of the Genascence partnership strategy. | |
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| The Aqueous Cleaning Handbook: Measuring Cleanliness | Article | By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin, Alconox Inc. | Gain insight into proper cleanliness detection, contact-angle measuring methods, the water drop surface energy test, and in-situ particle monitoring. |
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| Contamination Control Strategy With QRM Principles | Webinar | Koerber Pharma | Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS. |
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| 5 Steps To Implementing CSA | Article | Kneat Solutions | Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance. |
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| The rapid advance of ADCs has tested the fine balance between speed to IND and process development that stands up to the rigors of scale-up and transfer. Explore the processes leading ADC developers are employing to mitigate manufacturing-scale risk, and how automation and artificial intelligence are beginning to inform their work. Join Bioprocess Online Live for this interactive discussion. Registration is free thanks to the support of Thermo Fisher Scientific. |
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FOCUS ON QUALITY/ANALYTICAL METHODS |
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By Tyler Menichiello, contributing editor | Experts from Bristol Myers Squibb and Moffitt Cancer Center discuss best practices for analytical method development, as well as how to manage the successful transfer of these methods. | |
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| Automated Setup On BD FACSLyric Flow Cytometer Streamlines Workflow | Application Note | By Casey J. Fox, Mamatha Bharadwaj, Dina Huckaby, Maclean Nyachienga, et al., BD Biosciences | Examine the usability and performance capabilities of a system that provides a streamlined flow cytometry workflow, from instrument initialization to data acquisition and analysis. |
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| Validating The Efficacy Of A Compound With Spatial Imaging | White Paper | By Corinne Ramos, Ph.D., Aliri Bioanalysis | Discover how target and efficacy validation can translate into substantial savings and market advantages for sponsors as a result of shortened development and approval timelines. |
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| Webinar: Navigating Global Regulatory Landscapes in an Evolving Biopharma Industry | This webinar offers insights into managing raw material changes and navigating regulatory challenges in the biopharma industry. Experts will discuss collaboration between suppliers and users, risk management, change management, and adapting to evolving regulations. Key objectives include mastering regulatory guidance, implementing effective change management, and understanding market trends. Join us to explore best practices and remain compliant throughout drug development. Click here to learn more. |
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QUALITY/ANALYTICAL METHODS SOLUTIONS |
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Connect With Bioprocess Online: |
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