FEATURED ARTICLES

• Accelerating Bulk Harvest Release Testing With A PCR-Based Solution

  Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

• Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy

  RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

• The Next Generation Of mRNA Products: Implications For Quality Control

  To fully realize the potential of mRNA as a therapeutic or vaccine modality, developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.

• Benefits Of PCR-Based mRNA Manufacturing Processes

  Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.

• De-Risk mRNA Regulatory Approvals

  Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.

• Formulation Process And Analytical Development Capabilities

  Explore process and analytical development capabilities that can help you advance your formulation to GMP Manufacturing.

• Advancing A LNP Formulation To Clinical And Commercial Manufacturing

  Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

• Contrast In Oligonucleotides

  Explore the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.

• 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

  Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.

• 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.

• Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

  To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

• Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

  Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

• Establishing Analytical Methods For mRNA-Based Therapies

  Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

• Modeling The Economics Of Vaccine Manufacturing

  Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.

• How Data Analytics Accelerates Transition To Bioprocessing 4.0

  Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.

• mRNA Process And Cost Modeling: A Tool To Optimize Process Development

  Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.

• Biopharma 4.0: Convergence Of Information, Operations, And Processing Tech

  Biomanufacturers seeking a place in a competitive and lucrative future must start engaging in change now to meet the demands for delivering drugs more quickly to the patients who need them.

• mRNA Manufacturing And Formulation

  From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.

• How Digital Solutions Are Transforming Biomanufacturing

  See how the Digital Plant Maturity Model (DPMM) lays out each step and milestone to a paperless, automated plant in which real-time analytics are used in every step of every process.