BioProcess International

That's a wrap on our BioProcess International Conference & Exhibition 2024 in Boston! Aside from our enhanced onsite features including coffee baristas, daily live music, wine & cheese, lobster rolls, masseuse, manicurist, comfort seating, work pods, and charging ports in all session rooms, this year's event featured: ??3200+ bioprocessing professionals from 36 countries ??All top 20 largest biopharma companies ??100+ startups ??340+ industry leading?speakers?across 9?tracks ??220+ exhibitors?supporting the entire bioprocessing spectrum ??Offsite networking party at Museum of Science Check out the latest highlights from this year's event! #biotechweekboston #BPIevent #CellGeneEvent #bioprocessing

Be sure to check out our latest November-December 2024 issue of BioProcess International on product development - available in print and digital! This issue features fascinating articles from talented professionals. Read on for a preview of the articles linked below: From the Editor: November-December 2024 by Cheryl Scott. Temporal Analysis of Biomanufacturing Skill Development: Understanding the Needs of an Industry-4.0 Workforce by Jason Beckwith, Stephen Goldrick, William Nixon, Stavros Kourtzidis. Easing the Pathway for Combination Products: An Australian Regulatory Perspective by Piety Rocha, Heyam Kalla. Driving Sustainability in Biologics Process Development: Innovative Strategies and Technologies by David Roush, Sri Madabhushi. Process Development, Manufacturing, and Clinical Support for Bispecific Antibodies: Chemistry, Manufacturing, and Controls Considerations by Yanhuai (Richard) Ding, Bruce Andrien, Mohosin Sarkar, Mark Aimone, MBA. Biopharmaceutical Cleaning Validation: Experimental Evaluation of the Acceptable Exposure Limit for Inactive Therapeutic-Protein Fragments by Vibha Jawa PhD FAAPS, Joseph R. Cohen, Marisa Joubert, Jonathan Herskovitz, Michelle Monk, Angela Vera, Rizwan Sharnez. Optimized HCP Assay with Reduced Matrix Interference from Protein A: Improved Performance in Dilution Linearity and Spike Recovery by Bulat R Ramazanov, Shenjiang Yu, Khushboo Kapadia, Daria V. Sizova, Helen SooHoo, Emily Sciortino, Becky Phillips, Samantha Cote, Tony Dang, Bing Hu. Regulatory Consequences of New Protein-Impurity Guidelines by Ejvind M?rtz, Thomas Kofoed. Enabling Real-Time, Label-Free Analysis of Single Cells: A Discussion on Analytical Needs in Cell-Therapy Manufacturing by Brian Gazaille, Renee A. Hart. Address Challenges of Bispecifics and Antibody Fragments with Novel Affinity Resins by Chiu Lau-Barre. Reliable Data, Reliable Products: Maintaining Data Integrity in Bioprocessing Workflows (Webcast Recap) by Shweta Nair. From Concept to Cleanroom: Case Studies in Single-Use Fluid Management Collaboration (Webcast Recap) by Greg Verni, Derek Masser, Scott Bendon. Bringing Inclusivity in Cancer Research: How Technology Is Modernizing Clinical Trials by Harsha K Rajasimha. #productdevelopment #clinicaltrials #singleuse #celltherapies #sustainability Follow the link below to read the full issue: https://lnkd.in/gxeTkznH

Please join us for a #BPIAskTheExpert on "Filter Integrity Uncovered: Techniques and Best Practices." In this #webinar, gain insights into pre-use and post-sterilization integrity testing (PUPSIT) while discovering effective troubleshooting strategies for common testing issues. Join Saint-Gobain to deepen your understanding of filter integrity testing as they give an overview and definitions of integrity test methods, analyze the regulatory landscape and cover PUPSIT integrity testing troubleshooting. Date: Tues., December 3rd. Time: 11 AM ET. Featuring: Angelines Castro Forero, PhD, filtration technology manager & Hannah Hertrick, market development manager, Saint-Gobain Life Sciences. Register Now: https://lnkd.in/gE84cDmz

Please join us for a #BPIAskTheExpert on "Navigating Biopharma Commercialization: The Interplay of Regulatory Affairs, Process Development, and Manufacturing to Ensure Drug Quality." In this #webinar, join Lonza to explore the essential alignment between #regulatoryaffairs, #processdevelopment, and #manufacturing in #biopharmaceutical #commercialization. Their expert speakers will discuss how integrating these functions ensures drug quality, safety, efficacy, and enables navigation of the complex regulatory landscape. Understand how the synergy between regulatory and operational processes drives compliance, assures process control, and ultimately delivers high-quality products to market. Date: Thurs., November 21st. Time: 11 AM ET. Featuring: Yves SCHEURER, manager, regulatory affairs & Robin Schumacher, late-stage expert, Lonza. Register Now: https://lnkd.in/gCzCyDeS

Please join us for a #BPIAskTheExpert on "Linking mAb Product Quality Profile Changes to Your Bioprocess: Case Study of Dynamic Glucose Level Control in CHO Process Improves Product Quality." Changes made to the #bioprocess can be linked to product quality attributes, but only if there are frequent data points to show the development throughout the bioprocess. Access to good product quality data at frequent timepoints from a full bioprocess can be a tall order for the analytical department. In this #webinar, experts from 908 Devices, will present a simple dilute-and-shoot analysis using ZipChip capillary #electrophoresis separation coupled to a high-resolution #massspectrometer and a case study where a comparison of #CHO fed-batch process runs with the usual daily bolus glucose feed strategy and a 2g/L dynamic glucose feed strategy, enabled by MAVEN monitoring and control, resulting in clear improvement in product quality profile. Date: Tues., November 19th. Time: 11 AM ET. Featuring: Erin Redman, PhD, principal scientist & Graziella Piras, PhD, senior director of strategic marketing, life science, 908 Devices. Register Now: https://lnkd.in/gNGJ6fyn

Please join us for a #BPIAskTheExpert on "Evaluation of a New Multimodal Anion Exchange Resin for Emerging Biotherapeutic Process Challenges." Multimodal #chromatography has a history of providing value for #biopharmaceutical separations. Ligands that enable binding based on both charge and #hydrophobic interactions provide more opportunity for effective separation of multiple product- and process-related impurities. However, more diverse protein therapeutics and evolving expression systems present separation challenges that may not be easily addressed by commercially available multimodal resins. This #webinar will discuss several molecules that were prioritized for high-throughput evaluation of Nuvia wPrime 2A Resin, including an IgG1 monoclonal antibody (#mAb), IgG4 mAb, and a bispecific antibody (#bsAb), with extra focus placed on proteins with low isoelectric points (pI) and known strong binding to alternative MMAEX resins. Date: Thurs., November 14th. Time: 11 AM ET. Featuring: Michael Rauscher, Associate Principal Scientist, Process R&D Enabling Technologies, Merck. Register Now: https://lnkd.in/gsEG7Wjh

Please join us for a #BPIAskTheExpert on "AAE-MS?: A Powerful Method to Assess Host Cell Protein ELISA Fit for Purpose." Antibody Affinity Extraction (AAE) is a powerful orthogonal approach to determine if a host cell protein (HCP) ELISA is fit for purpose. AAE is referenced as immunoaffinity #chromatography in USP 1132 and has been used in over 300 projects to perform antibody coverage analysis for regulatory submissions. This #webinar will focus on several case studies demonstrating utility of AAE-MS method in identification of immunoreactive HCPs to establish HCP antibody coverage, HCPs enriched during process changes, and HCPs co-purified with DS. Date: Tues., November 12th. Time: 11 AM ET. Featuring: Jared Isaac, PhD MBA, Associate Director, Chromatography and Mass Spectrometry, Cygnus Technologies, LLC. Register Now: https://lnkd.in/gZNZEFkX

Please join us for a #BPIAskTheExpert on "Out of the Box Computer Software Assurance with ValGenesis VLMS." Computer software assurance (CSA) allows for faster deployment of your #validation needs compared to traditional computer systems validation (CSV). In this #webinar, learn how you can utilize modern methodologies and digital technologies such as ValGenesis’ VLMS to adapt your current CSV practices into CSA to streamline your validation process. Date: Thurs., November 7th. Time: 11 AM ET. Featuring: Jeff R., Solutions Engineer, ValGenesis. Register Now: https://lnkd.in/ghsVfBxC

We've had the great opportunity to speak to Eric Halioua, CEO of PDC*line Pharma, on the company’s journey from its inception to its current breakthroughs in cancer immunotherapies. Eric shared insights on the drive behind PDC*line Pharma's unique platform, the resilience required to push forward in biotech, and the impact of global partnerships. Stay tuned for more on how PDC*line Pharma is advancing clinical trials and what we can expect to hear from them at Cell and Gene Therapy International Europe, this December! Read more below: #cellandgenetherapy #biotech #bioprocessing

Please join us for a #BPIAskTheExpert on "Introduction to Lonza CHO Media Portfolio: Harnessing Simplicity with the TheraPRO? CHO Media System." The growing field of #antibody #therapeutics is revolutionizing #healthcare by offering more precise treatments for various diseases. This advancement demands that #pharmaceutical companies efficiently produce high-quality proteins in large volumes. In this webinar, Sanjay Kumar, PhD will discuss Lonza’s CHO media portfolio, with a focus on the TheraPRO? GS CHO media system, highlighting key attributes and sharing compelling data generated with this system. Date: Thurs., October 31st. Time: 11 AM ET. Featuring: Sanjay Kumar, PhD, Head of Technical Excellence, Media Solutions, Lonza Bioscience Media Solutions. Register Now: https://lnkd.in/gACTW4AG