Expert Insights On Downstream Bioprocessing

91. Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems 4/20/2023

    While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

92. 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.

93. 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.

94. A Brief Overview Of Vaccine Purification Technologies And Analytical Tools 3/23/2023

    Downstream processing remains a major bottleneck for vaccine production, and the industry is racing to develop new purification technologies. Here's a snapshot of where we stand and of what needs to happen next to increase quality and yields.

95. Transitioning From Monoclonal Antibody To AAV Separation Science 3/16/2023

    Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.

96. 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.

97. 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.

98. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

99. 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.

100. 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.