Expert Insights On Upstream Bioprocessing

81. Platforming Strategies To Increase Throughput With Better Standardization 3/2/2023

    Biologics development and manufacturing platforms should fit their target product profile. Here are four considerations for building more efficient platforms.

82. Insulin's 100-Year History Inspires Today's Biotech Industry 2/22/2023

    Former FDA regulator Jeffrey C. Baker, Ph.D., has been speaking on the history of insulin, the first biologic, at seminars and conferences for years. This year, those talks seem more important as we mark the 100th anniversary of this life-saving drug. Baker says insulin's story holds inspiration for today's biotech companies.

83. Using QbD Principles To Register Innovative Raw Materials 2/13/2023

    Control of biopharmaceutical raw materials is defined by the license holder. We propose a best practice approach to registering innovative and complex raw materials based on quality by design (QbD) principles. It can be applied to different families of non-compendial raw materials used when manufacturing biologics.

84. After Decades Of Biomanufacturing Workforce Development, What's Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

85. These Top 2022 Global Bioprocessing Trends Will Affect The Industry In 2023 12/22/2022

    For yet another year, COVID-19 and pandemic-related factors shaped the biopharmaceutical industry. It stretched supply chains and claimed qualified staff who otherwise would have been developing other drugs. BioPlan Associates, which publishes an annual industry survey, looks back on the biggest trends of 2022.

86. ICH Final Q13 Guideline For Continuous Manufacturing: What It Means 12/16/2022

    The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.

87. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

88. Help! The Particle Count Is Overwhelming Us! 12/12/2022

    Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.  

89. ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products 12/8/2022

    Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).

90. Where Do We Stand On Adopting Continuous Manufacturing For Biologics? 12/5/2022

    Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.