BioProcess International

Our April 2025 issue of BioProcess International on #ProductDevelopment is 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: April 2025 by Cheryl Scott. Blockchain for Biomanufacturing: Challenges and Global Talent Distribution by Jason Beckwith, Stephen Goldrick, William Nixon, Stavros Kourtzidis, Cameron Beckwith. Integrating Annex 1 Compliance into Fill–Finish Operations for Injectables by Chad Hafer. Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1 by Lori Richter, Ph.D, Martin Lipa, PhD, Nathan Pofahl. Keeping Secrets Safe: Considerations for Trade Secret Protection in the United States amid Biotechnology Layoffs by Laura Smolowe, Taylor Benninger. Best Practices for In-Use Stability and Compatibility Studies: A Summary of the 2024 CASSS CMC Strategy Forum, Part 1 by Jing Liu, Markus Blümel, Jennifer S., Félix Jules, PhD, Sarah Weiser, Jennifer Litowski, Martin Nemec, Ph.D., Isabella de Jong, Michael Moses, S. Anne Montgomery. Essential Performance-Requirement Assessment of Prefilled Syringes: Break-Loose and Gliding-Force Measurement and Analysis by SANTOSH JADHAV, Deepesh Bhatt, Ph.D. Studying Protein Higher-Order Structure and Immunogenicity Correlation: with Protein Conformational Array and Cytokine-Panel Analyses by David L. Wang, John Hackmann, Xing Wang. Big Impact from Small Samples: Harnessing HPTLS for Complex Bioprocess Analysis (Webcast Recap) by Larissa Miropolsky. Advancing mRNA-Based Vaccines and Therapeutics in CMC: From Process Development to Analytics (Webcast Recap) by Shanshan Wang. Process Intensification Through a Perfused N – 1 Bioreactor (Webcast Recap) by Marissa Dickson, Brian Hadley. Unraveling CLD Complexities in Viral-Vector Manufacturing by Inês do Carmo Gonçalves, PhD. Strategizing Biopharmaceutical Supply Chains by Sham Ambhore. Follow the link below to read the full issue: https://lnkd.in/gXFsNs5n

Throwback Thursday to BioProcess International 2024! If you missed out... here's what you didn't see    - Jam-packed sessions with the industry's biggest leaders   - Drinks reception networking at our infamous Museum of Science Party   - Exhibit hall filled with the newest innovations in the biopharma space    Watch the highlight reel from last year's event and get a glimpse of the buzz. Make sure you join us in 2025 in Boston, MA from September 15-18.    Early bird pricing ends May 9th so secure your pass and save now: https://lnkd.in/e6TiPaHj Check out the agenda: here: https://lnkd.in/esnmjhZb    #TBT #BPI #Bioprocessing #LifeSciences 

Please join us for a #BPIAskTheExpert on "Resin Innovation to Support Downstream Processing of Biotherapeutic Modalities." Antibody-based #biotherapeutics represent one of the fastest growing segments in the #pharmaceutical market, in part due to the groundbreaking innovation with the molecules themselves. The advent of multi specifics, Fc-fusions, and antibody fragments provide increased efficacy over standard #mAbs, allowing exploration of novel therapeutic areas. This #webinar will look at the advancements in Purolite™ specialized resins, which optimize molecule stability, enhance efficiency, reduce costs, and improve product quality. Date: Thursday, April 24th. Time: 11 AM ET. Featuring: Johanna Howson, PhD, Lead Application Scientist, Ecolab Life Sciences. Register Now: https://lnkd.in/gCWiRiBh

Registration is now LIVE for BPI Spring Digital Week! We're bringing together the bioprocessing community for a week of the newest cutting-edge insights from industry leaders at Lonza, Virica Biotech, Eppendorf and more! ✅ Learn from top experts in the field ✅ Discover the latest trends in bioprocessing ✅ Hear how top companies are tackling the biggest hurdles affecting the industry Register for FREE now and make sure you don't miss a moment: https://lnkd.in/eP-sCz3p

Please join us for a #BPIAskTheExpert on "Analytical Solutions for Monitoring Host Cell DNA During Biologic Manufacturing." Persistence of residual #DNA during manufacture of #biotherapeutics poses a risk to patients due to the introduction of potentially problematic genetic material. This webinar will introduce the utility, flexibility, reproducibility, and sensitivity of Cygnus AccuRes™ Host Cell DNA Quantification Kits to monitor host cell DNA originating from human, E. coli, or CHO cell lines. Date: Tuesday, April 22nd. Time: 11 AM ET. Featuring: Eric Bishop, Vice President, Research and Development, Cygnus Technologies, LLC. Register Now: https://lnkd.in/g335rK8J

BioProcess International Europe 2025  12-15 May 2025 | Congress Center, Hamburg | Hamburg, Germany    BioProcess International Europe (BPI Europe) 2025 in Hamburg is the industry’s premier event for advancing biopharmaceutical development and production. This year’s event focuses on optimizing efficiency and achieving the highest quality standards for mAbs, biologics, and ATMPs – accelerating the journey from molecule to market. Join industry leaders, renowned scientists, and technology providers to uncover groundbreaking solutions, spark ideas, and bridge the gap between theory and practice.  Beyond the cutting-edge content, this event offers a vibrant and engaging atmosphere. Enjoy networking lunches, wellness activities, and drinks receptions, including an evening at the iconic Altes Mädchen Ratsherrn Brewery. With 1,000+ bioprocessing professionals, 125+ expert speakers, and 90+ exhibitors, this is the ultimate opportunity to enhance your expertise, build connections, and experience the best of Hamburg. Don’t miss it!  https://lnkd.in/eVYbRcZy #Bioprocessing  

Bioprocessing Insights On-Demand!    Upskill your team smarter this spring. Access cutting-edge strategies for next-gen therapies anytime, anywhere.     🎁Easter Special: Register by Friday, April 18 using VIP code: LinkedInBOGO and get 2 logins for the price of 1.    🎥 Choose from 4 specialized libraries filled with recorded case studies and new data presentations from recent BioProcess International events. No travel, no scheduling conflicts, no excuses for your team not to be involved.   Train your team today: https://lnkd.in/ew7TvHCs

This is the final week to lock in early bird pricing for BioProcess International Europe happening next month! - Get access to sessions from across all phases of bioprocessing - Connect with senior decision-makers from across the continent - Hear from industry leaders shaping the future of biologics Get an extra 10% off using the discount code "LINKEDIN10" and save even more : https://lnkd.in/dvxSKf4H

Take a look at this #eBook titled, "Process-Related Impurities — New Approaches for a Modern Era" by Cheryl Scott, Naveenganesh Muralidharan, Leya S. Rose, Mark Davis, Timothy Licknack, Alla Zilberman, Johanna Barnhill, Stephen Stahlschmidt, Jared Isaac, PhD MBA. Process-related impurities can manifest at any #biomanufacturing stage. When they remain in medicines that are dosed to patients, they can induce reactions from minor fever and inflammation to hemorrhagic shock and sepsis. Such risks, as well as concerns for drug-product stability and efficacy, make impurity prevention and removal imperative. Contributors to this eBook highlight difficulties and opportunities for detecting and controlling a breadth of contaminants. Read this eBook for insights on the entire spectrum of impurities that need to be removed from drug substances and products. https://lnkd.in/g2mVfUGr

The BioProcess International 2025 Agenda is LIVE!    We are so excited to announce that the agenda for BioProcess International, happening September 15-18, 2025 is officially live.  Check it out here: https://lnkd.in/eZfKPydP   Already confirmed keynote sessions from:   - Wolfram Carius, Phd from Bayer - Erin Kimbrel, from Astellas Pharma Institute for Regenerative Medicine  - And more!    Bring back cutting-edge insights to your team. Discover strategies to slash costs and scale your manufacturing pipeline   Get your tickets now at the lowest price tier and get an extra 10% off with VIP code LINKED10:  https://lnkd.in/ePQBYNDT