FEATURED ARTICLES

• 4 Considerations For Overcoming Challenges In Gene Therapy Testing

  With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.

• The Post-Pandemic Supply Chain: Improving Resilience Via Value Chains

  The COVID-19 pandemic underscored the vulnerability of global supply chains. Explore lessons learned from the pandemic, the concept of supply chain resilience, what to look for in a supplier, and more.

• Vaccine Maker's Toolkit: Strategies For Manufacturing And Supply Management

  This collection of insights highlights strategies and guidance to ensure reliable biomanufacturing capacity and supply chains for the delivery of health technologies, even during crisis conditions.

• Streamlining Biomanufacturing Automation With Connectivity And Integration

  We outline the evolution and recent advancements in connectivity and integration technology, highlighting the associated challenges, and offer insight into the importance of a vendor-neutral approach.

• Testing Cell-Based Immunotherapeutics For Microbial Contaminants

  In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex® Rapid System to establish a USP and EP compliant method for rapid sterility testing.

• Optimizing And Scaling Lentiviral Vector Production

  Here, we outline how the upstream and downstream workflows of the VirusExpress® platform for lentiviral vectors were optimized through the use of design of experiments and supplementary studies.

• Reducing The Level Of Host Cell Proteins In The Bioreactor Harvest

  Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

• Ensuring Biomanufacturing Resilience For Biologics And Vaccines

  We highlight strategies for ensuring the reliable delivery of health technologies with a focus on vaccines, mAbs, and new modalities manufactured by biotechnology companies and institutes.

• Development Of A Novel Cell Culture Medium For AAV Production

  Explore the medium development process of a novel cell culture medium for AAV production with multiple HEK293 lineages, which was performed with three different HEK293 cell lines to maximize AAV titers.

• Economics For Vaccine Manufacturing: Comparing Traditional To Modern Modalities

  Explore key points from the presentation MilliporeSigma delivered on the analysis and comparison of manufacturing costs between traditional and modern vaccines at the World Vaccine Congress Washington 2023.

• Why Choosing A Client-Centric CTDMO Is Critical In Biomanufacturing

  Outsourcing to a CTDMO is a promising solution for companies lacking the technical expertise and in-house capacity to address biomanufacturing challenges. Learn why selecting the right CTDMO partner is vital for project success.

• Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization

  There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

• Optimizing The Formulation For A Monoclonal Antibody

  An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how MilliporeSigma delivered an optimized formulation within an aggressive timeline and budget.

• Market Watch And Perspectives On Vaccines Manufacturing In APAC

  Nearly forty biopharmaceutical companies, CDMOs, and research institute executives took part in interviews on the future of vaccine manufacturing. Explore the key findings following these interviews.

• The State Of Plastics Recycling In BioPharma

  Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.

• Novel Gas Delivery, Distribution, And Scalability Strategies

  Our aim was to create scalable, single-use sparger and impeller designs that offer maximum performance capable of supporting high viable cell densities while cognizant of cell shear sensitivities.

• A Power Number Model-Based Approach For Scalable Impeller Designs

  The aim of this work was to use a power number model-based approach for the design of a scalable single-use impeller capable of reaching high power densities with low mixing time and tip speed.

• Scalability And Performance Of Single-Use Bioreactors

  Here, we provide scalability data as a guide for process development and cross-scale performance expectations and characterize performance attributes of the impeller, spargers, Ultimus® film, and sensors.

• Bioreactor Scalability Supports Intensified Upstream Process Development

  In this study, key parameters for the Mobius® 3 L Single-Use Bioreactor and the 50-2000 L Mobius® iFlex Bioreactor impeller designs were characterized. Learn about bioreactor scalability for intensified processes.

• A Comparative Analysis Of Mixing Characterization Methods

  In the bioprocessing industry, there is no single, standard method for measuring mixing performance. Here, we investigate the four most widely used methods for measuring mixing time.