BioProcess International

The June 2024 Outsourcing issue of BioProcess International is available in print and digital! This issue features fascinating articles from talented professionals. Read on for a preview of the articles linked below: Keys to Successful Technology Transfer by Olena Chervonenko, Gerardo Gomez, Ph.D. Transforming Biopharmaceutical Research Embracing the Potential of Digital Collaboration Platforms by Narendra Sharma, Siddhartha Jain. Elevating the CGT Manufacturing Game: How Outsourcing Enables Success by Omkar Kawalekar, Audrey Greenberg, Amit Agarwal. US–India Collaborative Innovations for Rapid Drug Discovery by Jitendra Kumar. Extending the Visible Residue Limit Approach to Potent Therapeutic Proteins — Part 2: Test Results and Conclusions by Ram Kouda. PhD, MBA, LSSMBB, Syeda Tabassum, Kurt Schnittgrund, Travis Rudd, Dave Dolan. Establishing a Life Cycle for Relaundered Cleanroom Garments by Tim Sandle, Ph.D., CBiol, FIScT. Lessons in Bioreactor Scale-Up, Part 2: A Refresher on Fluid Flow and Mixing by Muhammad Arshad Chaudhry. High Aggregate Levels with Engineered Monoclonal Antibodies: An Innovative Approach to Addressing the Challenge by Ying Chen, Al de Leon. Turning Biologic Innovation into Commercial Success (Webcast Recap) by Nikolaus Hammerschmidt, Athelney J. Woolnough, Franz Schuster. Moving Towards Scalable AAV Vector Production with High Volumetric Efficiency (Webcast Recap) by Prasanna Srinivasan, Graziella Piras. #outsourcing #digitalplatform #CDMO #cellandgenetherapies #bioreactors Follow the link below to read the full issue now. https://lnkd.in/g9r8WhpB

The latest episode of the Voices of Biotech #podcast is here! This episode features Claire Macht, Portfolio Director, Europe & Manuela Hildebrand, Regional Delivery Director, both from EBD Group, as they have a conversation with Millie Nelson. Click the link below to hear them discuss how #sustainability measures are implemented from an operational standpoint at conferences such as reuseable booths, less food and beverage wastage, more plant-based/vegetarian options, and even the much-debated topic of carpet or no carpet in the exhibition hall, and more. Full episode here: https://lnkd.in/gz3q5YGX

Take a look at this on-demand #AsktheExpert webcast, "Reduce Risk and Enable Continuous Manufacturing Using Pre-Packed Columns for Multicolumn Chromatography." Featuring: Adam Nelson, Chromatography Product Manager, Repligen Corporation. In the #biopharmaceutical industry, enhancing process productivity and facility efficiency while mitigating the risk of column packing failure remains a critical endeavor. This #webinar delves into the technical nuances of leveraging pre-packed #chromatography columns to achieve these objectives. A compelling case study showcases tangible savings achieved by a customer through the adoption of pre-packed columns for continuous manufacturing. By transitioning from self-packed columns to pre-packed columns, the customer realized substantial cost savings in terms of dollars, time, training, and skilled resources. The transition then allowed the manufacturer to reallocate the packing room space for other process activities, thereby improving facility efficiency. Furthermore, the adoption of pre-packed columns led to reduction in the risk associated with column packing failures; therefore, safeguarding manufacturing processes against disruptions and ensuring uninterrupted production schedules, optimizing productivity. Click the link below to view the on-demand webcast now. https://lnkd.in/gH84AQmR

The next episode of the Voices of Biotech #podcast arrives later this week! Keep an eye out for the conversation with Claire Macht, Portfolio Director, Europe & Manuela Hildebrand, Regional Delivery Director, both from EBD Group, as they speak with editor, Millie Nelson, about the latest in the industry. Listen to previous episodes here: https://lnkd.in/gnHuwkaW

Please join us for a #BPIAskTheExpert on "Advanced Analytical Strategies: From Protein Structure Characterization to Potency Assessment for Challenging Biologic Modalities." In the rapidly evolving landscape of #biologics, especially for new modalities like antibody drug conjugates (#ADCs) and bispecific/multi-specific #antibodies, detailed #productcharacterization evaluation and appropriate potency assessment are crucial for ensuring product quality control and fulfilling regulatory requirements. This webinar will dive deeper into the following topics: Deciphering Protein Structure: Advancing Biologics Development Through Product Characterization & Revealing Biologics Efficacy: Advanced Strategies for Potency Assay Development for Multi-Specific Drugs Date: Thurs., June 27th. Time: 11 AM ET. Featuring: Tongdan Wang, PhD, Senior Director, Analytical Sciences & Xinyuan Lu, PhD, Senior Director, Analytical Sciences, WuXi Biologics. Register Now: https://lnkd.in/ghDWX-uR

Please join us for a #BPIAskTheExpert on "Built to Serve Innovation: A Briefing on Commercial Readiness at Resilience." While many #biopharmaceutical companies are built to fulfill a need, Resilience was built to serve #innovation. With a #sustainable network of high-tech, end-to-end #manufacturing facilities based in North America, Resilience is dedicated to providing #supplychain solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. In this #webinar, Resilience #biomanufacturing leaders will introduce our commercial capabilities by showcasing existing commercial sites and sharing plans to onboard new commercial products into the network. Additionally, Resilience leaders will highlight our development and manufacturing site in Alachua, Florida and outline its path towards commercial readiness. Date: Tues., June 25th. Time: 11 AM ET. Featuring: Duane Avant, Chief Quality Officer, Luis Oscar García, VP and General Manager, Site Head for Alachua Site, Resilience. Register Now: https://lnkd.in/gHzUtKeK

Please join us for a #BPIAskTheExpert on "Minimize Risks in Late-Stage Projects Through Quality Partner Selection." The development and delivery of pharmaceutical drugs require a complex process involving stringent clinical assessments and #CMC packaging considerations. #CDMOs play a crucial role in #manufacturing drugs and meeting CMC requirements and timelines. This case study highlights Avid Bioservices' ability to address challenges for clients with late-stage projects at other CDMOs. Issues with timeline adherence and #CGMP compliance led clients to seek alternative solutions. Avid facilitated a seamless tech transfer, integrated the projects into their facilities, and executed a process performance qualification (PPQ) campaign without major setbacks, achieving an on-time product launch. Date: Tues., June 18th. Time: 11 AM ET. Featuring: Pramthesh Patel, Vice President, Process Development, Avid Bioservices. Register Now: https://lnkd.in/gbc-WRrs

Please join us for a #BPIAskTheExpert on "Minimize Risks in Late-Stage Projects Through Quality Partner Selection." The development and delivery of pharmaceutical drugs require a complex process involving stringent clinical assessments and #CMC packaging considerations. #CDMOs play a crucial role in #manufacturing drugs and meeting CMC requirements and timelines. This case study highlights Avid Bioservices' ability to address challenges for clients with late-stage projects at other CDMOs. Issues with timeline adherence and #CGMP compliance led clients to seek alternative solutions. Avid facilitated a seamless tech transfer, integrated the projects into their facilities, and executed a process performance qualification (PPQ) campaign without major setbacks, achieving an on-time product launch. Date: Tues., June 18th. Time: 11 AM ET. Featuring: Pramthesh Patel, Vice President, Process Development, Avid Bioservices. Register Now: https://lnkd.in/gbc-WRrs

Day 2 of the BioProcess Theater is well underway at booth #5443! View the agenda here to see what’s in store for the rest of the day. Don’t forget to stop by the BPI booth at #5451. #BIO2024 https://lnkd.in/dY9F6m4z

Learn about today's novel bioprocessing technologies that can help you optimize efficiencies in process development, cell line development, upstream/downstream processing and manufacturing strategies by attending next week's BioProcess International Digital Week live webinar series, held June 10-12, 2024. View the full agenda and register for your complimentary webinar today at https://lnkd.in/gRkhThPK Can't make the live sessions? Register at the link above to receive a copy of the presentation recordings! ------------ JUNE 10 ------------ Essential Digital and AI Capabilities to Unlock the Power of Your Process Development Data Michael Schwartz, Product Specialist, Process Development, Benchling Justin De La Cruz, PhD, Solutions Consultant, Process Development, Benchling The Business Value of a Modelling and Data Driven Culture for Advanced Manufacturing Joseph Pekny, Professor, Purdue University Harnessing the Power of Cell Therapy: A Big Pharma Approach from Idea to Commercialization of a Manufactured Cell Therapy Product Tania Incitti, Associate Principal Scientist, AstraZeneca ------------ JUNE 11 ------------ Evaluating a New Virus Filtration Membrane for Challenging Bioprocessing Application Christine Stouffer, Senior Research Associate, Asahi Kasei Bioprocess America, Inc. Enhancing Process Efficiency with High-Quality Animal-Free Ingredients for Vaccine, Monoclonal Antibody (mAbs), and Cell Therapy Development Sara Bursomanno, Global Product Manager, Novo Nordisk Pharmatech A/S Marie-Louise Lunn, Ph.D, Global Product Manager, Novo Nordisk Pharmatech A/S Turning Biologic Innovation Into Commercial Success: Boehringer Ingelheim’s Expertise in Microbial Technology Athelney J. Woolnough, Director Business Development/Key Account Management BioXcellence, Boehringer Ingelheim Franz-Rudolf Schuster, Strategy Implementation Manager Biopharma Austria, Boehringer Ingelheim Nikolaus Hammerschmidt, PhD, Head of Unit Downstream Development, Process Science RCV Vienna, Boehringer Ingelheim ------------ JUNE 12 ------------ Using Gyrolab® for HCP Analysis in Early Bioprocess Development Martin Voigtmann, Senior Scientist Analytical Development, Boehringer Ingelheim RCV GmbH & Co KG Downstream Process Intensification for Cell and Gene Therapy Bioprocessing Marc Hummersone, Senior Director, R&D,  Astrea Bioseparations Cell, Vector and Media Engineering to Facilitate Production of Next-Generation Biopharmaceuticals Adam Brown, Associate Professor of Biopharmaceutical Engineering, CTO The University of Sheffield #bioprocessing #bpievent Informa Connect Life Sciences