Expert Insights On Upstream Bioprocessing

81. Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity 4/19/2023

    Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.

82. Add Biologics Manufacturing Efficiency With Design Of Experiments, Part 2 4/5/2023

    By reducing the total number of experiments, design of experiments methods streamline process optimization. With fewer tests, drug makers can spend less of their budgets on screening and more on process characterization.

83. A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development 3/29/2023

    Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.

84. Best Practices For Cell Culture Media Fingerprinting 3/13/2023

    This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available. 

85. Add Efficiency From Development To Validation With Design Of Experiments 3/10/2023

    A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.

86. 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.

87. 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.

88. 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.

89. 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.

90. 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.