Industry Insights

31. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

    Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

32. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

33. Industry Leading Hybridoma Technique For Accelerated Antibody Discovery 3/27/2025

    Leverage the power of hybridoma technology for efficient monoclonal antibody development, ensuring native gene pairing, class switch recombination, and seamless scalability.

34. De-Risking Cell Therapy Development: 4 Keys To A Streamlined IND Path 10/23/2024

    The first in a two-part series focuses on the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 IND application.

35. Cell Therapy: Process Design Considerations To Support Commercialization 3/28/2017

    Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.

36. Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products 11/6/2020

    This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

37. Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses 10/18/2023

    Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.

38. System Risk Structures: A New Framework For Avoiding Disaster 7/13/2020

    Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.

39. Solving 5 Overlooked Challenges In ADC Manufacturing 8/14/2024

    Delve into the intricacies of ADC production and learn how cutting-edge technologies are being deployed to overcome these hurdles to bring life-saving treatments to patients.

40. Scaling Personalized Medicines For Flexible Aseptic Filling 2/14/2024

    Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.