Bioprocess Online

Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities This analysis examines current implementation trends, operational advantages, productivity impacts, and quality integration strategies based on real-world performance data from leading pharmaceutical organizations. By @Ashok Kumar Dasari, Viatris BLR India https://lnkd.in/ea8AXCvE

If you missed this the first time, now’s your chance. Building a Purification Toolkit for an Expanding Variety of mAb Therapeutics is now available on demand. In this session, Thermo Fisher Scientific experts Chantelle Gaskin, Carlos Ferrero, and Ryan Hubbell, MS, MBA share practical strategies to help downstream scientists tackle complex mAb purification challenges with more flexibility and confidence. Learn how to: • Build a versatile downstream processing toolkit • Match chromatography resins and buffers to diverse mAb formats • Integrate purification solutions for better yield and purity Watch now and sharpen your downstream purification game. Watch the full event here:

Minimizing The Impact Of Human Errors Using Relational Risk Analysis Mark F. Witcher, Ph.D. describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks. https://lnkd.in/eJR8QkB8

Innovating Upstream: Bioreactor Design and Process Optimization for Scalable mAb and Cell Therapy Production 📅 August 11, 2025 | 🕚 11:00 AM ET Don’t miss this opportunity to hear from Brau Christopher, R&D Sr Manager of Bioprocess Production Innovation & Integration at Thermo Fisher Scientific. With a background spanning chemical engineering, biochemistry, and systems design, Christopher brings a unique cross-disciplinary lens to upstream process development. He’ll share real-world applications of advanced bioreactor design, control systems, and PATs to enhance scale-up efficiency for both monoclonal antibody and cell therapy workflows. Key takeaways: 🧪 Optimizing bioreactor platforms for upstream performance 📈 Strategies to accelerate scale-up for mAb and CGT 🧠 How cross-functional innovation drives better outcomes Whether you're focused on mAbs or next-gen therapies, this session will deliver actionable insights for upstream success. Register Here: https://lnkd.in/eYdbMC6F

Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities This article provides an overview of the environmental monitoring performance qualification (EMPQ) process in new facilities, from prerequisites to post-qualification activities. By BioPhorum https://lnkd.in/eNhZpc_s

The 2025 ISPE Annual Meeting & Expo will include a series of expert-led workshops designed to address some of the most pressing challenges and emerging opportunities shaping the future of the pharmaceutical industry. Topics will span drug development, regulatory compliance, digital transformation, and career advancement. Featured Workshops ◾ “Facilitating Analytical Procedure Changes via ICH Q14” ◾ “Integrated Process for Drug-Device Combination Products” ◾ “The Decision Process for Continuous Biomanufacturing” ◾ “Implementing an AI Solution in a Pharma 4.0™ Context” ◾ “From Imposter to Impact: Reinventing Your Career with Confidence” Each workshop offers practical insights and strategic guidance for professionals across various stages of the pharmaceutical product lifecycle. View the agenda: https://qrco.de/25AM

The Building Blocks Of A Robust Analytical Assay By Rishi Kothari Analytical assays are the backbone of drug development—yet building one can take over a year. From HPLC to PCR, these assays ensure quality, safety, and compliance at every stage. But developing a robust, validated method requires careful planning, risk analysis, and performance testing across parameters like specificity, linearity, LOD/LOQ, and precision. This breakdown walks through the strategic steps—from early method design to ICH-compliant validation—that can make or break a therapy’s success. https://lnkd.in/eE9r76zP

August is heating up with fresh insights on Bioprocess Online—don’t miss these upcoming webinars that are shaping the future of biomanufacturing. Links in the comments.

Efficient Scale-Up of Monoclonal Antibody Production: From Bench Top to 500L 📅 August 11, 2025 | 🕚 11:00 AM ET Join us for a focused look at downstream strategy with Jett Appel, Purification Field Applications Scientist at Thermo Fisher Scientific. With hands-on experience in biologics purification—from monoclonal IgGs to bispecifics—Jett brings deep insight into designing efficient, scalable DSP workflows. This webinar will explore how a two-step purification approach—MabCaptureC™ Protein A capture followed by POROS™ HQ anion exchange chromatography—was successfully applied across production scales from 3L to 500L. Key takeaways: 🧬 High-yield, high-purity DSP across scale 🔄 Process simplicity that supports scalability ⚙️ Strategies for maintaining product quality during expansion Jett’s perspective is essential for scientists and engineers optimizing mAb production pipelines. 🔗 https://lnkd.in/ez36HGpy