Biosimilar Manufacturing solution center
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Biofluorescent Particle Counters Are Gaining Momentum
4/28/2025
The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.
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CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics
4/28/2025
CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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Helpful Biosafety Testing Innovations Where And When You Need Them
4/24/2025
Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Process Analytical Technology In The ADC Bioconjugation Process
4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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Common Manufacturing Challenges For LBP Formulations
4/23/2025
As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.
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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
4/17/2025
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
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Pharmaceutical Sovereignty: The Resilience We Cannot Outsource
4/15/2025
Pharmaceutical sovereignty is no longer a theoretical concern. Sovereignty in this context does not imply isolation, but rather strategic resilience: building robust national and regional capabilities that ensure security while enabling global collaboration.
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Transforming Life Science With Remote Equipment Monitoring
4/15/2025
Life science organizations are shifting to data-driven oversight to enhance equipment uptime and drive continuous improvement. Discover how remote monitoring technologies are revolutionizing operational efficiency and innovation.
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Optimizing TFF And SPTFF For High-Concentration mAb Formulations
4/9/2025
Discover the critical role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.