BioProcess International

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 Mørtz, 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

Take a look at this special report titled, "Overcoming Challenges in AAV and LV Viral Vector Manufacturing: How To Design and Launch a Successful Clinical Materials Program" by Mathias Kahl, Stephan Bauer, Daniel Kohler, Tobias Thom, Rico Hinrichs, Stefan Borutzki, Christina Pospisil, Rico Schmidt, Erik Arnold, Thomas Kreisig. Learn about IDT Biologika's contract development and #manufacturing of virus-based #vaccines and gene & immune therapies. Their team has extensive experience in the development and production of viral vectors, particularly in the use of Adeno-Associated Virus (AAV) platforms and also provide own cell lines for manufacturing. They are prepared to help you to overcome challenges in the #processdevelopment and manufacturing of your #AAV and #LVV products. Read more about how IDT Biologika's expertise and experience can best serve your projects here: https://lnkd.in/gAGxcgRm

Enjoy this special report titled, "Smarter, Faster Protein Aggregation Detection with Membrane Microscopy: Rapid, Accurate Identification and Characterization of Subvisible Particles with Next-Generation Microscopy" by Bernardo Cordovez and Steven Le. Unlock the potential of your #biopharmaceutical research with Halo Labs latest report on advanced particle detection. Explore how cutting-edge technologies like fluorescence membrane microscopy (FMM) and backgrounded membrane imaging (BMI) are revolutionizing the identification and characterization of subvisible particles and discover how these innovations offer rapid, accurate insights into particle origins, enabling you to enhance drug stability and safety with unprecedented precision. Read the full report here: https://lnkd.in/gfvjfGvn

In this special report titled, "Process Intensification: Overcoming the Inefficiencies of Traditional Fed Batch in Upstream Cell Culture" by Charles Hill, explore how process intensification can transform your biomanufacturing processes. The custom report from Repligen Corporation highlights the inefficiencies of traditional batch and fed-batch methods and demonstrates how process intensification technologies, such as the XCell ATF System and the KrosFlo TFDF System, can improve the #economics, #productivity, and #sustainability of your biologics and #cellandgenetherapy #manufacturing. Read the full report here: https://lnkd.in/gaZWbzuF

Take a look at this #eBook titled, "Product-Related Impurities — From Identification to Prevention of Product Variance" by Cheryl Scott, Naveenganesh Muralidharan, Tyler Younger, Grace C., Shandilyn Drudy (Ball), Mark Davis, Emma Bolduc. Product variants differ from desired biological proteins in their structure, activity, efficacy, and even safety. Unlike process-related impurities — which must be monitored, controlled, and cleared during downstream processing — product variants can be managed partly through preventive measures. Authors in this eBook highlight recent advances in technologies for detection and identification, trends in formulation that complicate the product-variant issue, and chemical and genetic means of preventing changes to protein structure during processing. Read the full eBook here: https://lnkd.in/gxm4uQAi

Take a look at this special report titled, "Considerations for the Journey to Commercialization" by Min Park, MBA. The journey from #preclinicaldevelopment to #commercialization of a new #biopharmaceutical is long and challenging. The entire process requires persistence, adaptability, and strategic foresight. Only with a well-coordinated effort across disciplines and business functions can a new biologic drug successfully advance from laboratory to market. Partnering with a #CDMO can be invaluable in navigating such challenges to provide flexibility, enabling drug sponsors to focus on their core competencies while relying on their partners to handle the intricacies of #manufacturing and #regulatory compliance. Such partnerships can reduce risks significantly and help ensure that a new biologic reaches the market as efficiently as possible. Read the full report from Aton Biotech here: https://lnkd.in/gJyt65dX

Enjoy this #eBook titled, "Advancing Autologous Cell Therapies — Collaboration is Key" by Jason Bock. The promise of autologous #celltherapies is sometimes overshadowed by problems such as high #manufacturing costs, #scalability concerns, and an overall lack of infrastructure that enables easy access for patients. Such concerns have led investors toward allogeneic alternatives, which seek to alleviate some of those difficulties by providing a cheaper off-the-shelf solution. Unfortunately, allogeneic therapies have a downside, having shown less clinical success than existing autologous therapies. Read the complete eBook to discover how autologous cell therapies can improve their trajectory, reach their potential, and save more lives. Read the full eBook here: https://lnkd.in/ght7JYyB

Enjoy this special report titled, "Redefining Cell Line Development with a New Automated Clone Screening System" by Dr. Sebastian Hofzumahaus. The Cydem VT system combines multiple trusted Beckman Coulter Life Sciences technologies into one advanced platform that empowers lab managers with a far more effective, higher-throughput method for top clone screening in #celllinedevelopment —offering increased confidence that promising clones don’t get overlooked in the process of consistently selecting the best. Read the full report here: https://lnkd.in/gagNfF6T

Please join us for a #BPIAskTheExpert on "Advanced CLD with S-CHOice®: Higher Productivity with Transposase Technology and Improved ADCC with S-AfuCHO™." In this #webinar, learn how the S-CHOice® platform, powered by transposase technology, tackles common #celllinedevelopment challenges such as low protein expression, multi-chain molecule complexity, and clonal instability. It ensures efficient and #scalable #biologics production while meeting stringent timelines and reducing product impurities. Join this webinar to learn how these platforms optimize CLD performance and support efficient, reliable production of complex biologics. Date: Thurs., December 12th. Time: 11 AM ET. Featuring: Janet Lee, director, cell line development, Samsung Biologics. Register Now: https://lnkd.in/grtjFpXF

Kicking off our 12 days of Connect giveaway, here’s your chance to win a pass to BioProcess International (BPI) US West!   Serving the Life Sciences community, BPI US West brings together industry leaders and experts to explore how AI, sustainability practices and advanced manufacturing are leading the way forward.   Soak up the San Diego sun from March 18-21 and join the bright minds attending BPI US West to create a brighter future.   Here’s how you can enter the giveaway:    ⭐ Follow Informa Connect on LinkedIn and Instagram  ⭐ Follow BioProcess International on LinkedIn ⭐ Comment below sharing why you’d like to attend BPI US West   1 comment per account per social media platform. 1 prize only. Entries accepted until 8.59am ET on 5th December. View the full terms and conditions here: https://lnkd.in/gamqaqjZ #12DaysOfConnect #LifeAtInformaConnect