Expert Insights On Upstream Bioprocessing

91. 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.

92. Modularity And Mobility Hold The Keys To Surge Manufacturing 11/30/2022

    When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

93. A Methodology To Support Particle Investigations In Biopharma Products 11/22/2022

    Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

94. Biology Meets Computer Science For Next-Gen Biologics Drug Discovery 11/15/2022

    We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.

95. Assessing Quality Of Viral Vectored Vaccines 11/11/2022

    While viral vectored vaccines have been previously developed against Ebola virus, the COVID-19 vaccines were the first widespread global application of this vaccine platform. Adenovirus vectored vaccines have unique critical quality attributes that must be tested to ensure quality and safety.

96. Cost-Effective Biomanufacturing Of Lentiviral Vectors 11/2/2022

    This article compares fundamentals of current and upcoming lentiviral production processes and highlight areas of improvement that would allow an increase in manufacturing cost-effectiveness. Strategies discussed are production methods, cellular platforms, and bioprocessing options.

97. How Can Nanomedicine Innovations Combat Cancer? 10/24/2022

    For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.

98. Digital Twins & The CGT Value Chain: A Universe Of Possibilities 10/21/2022

    The cell and gene therapy revolution is coinciding with advanced digital technologies. At the forefront are digital twins, which combine at-scale computing, modeling methods, and IoT connectivity to create full-scale digital replicas of physical assets or real-world processes, such as factories, value chains, and even humans.

99. Assessing Quality Of mRNA Vaccines: Key Considerations 10/12/2022

    To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.

100. Pharma Process Validation: Initial Conclusions Are Often Deceptive 9/26/2022

     As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.