Featured Articles

  1. Manufacturing Strategies For mRNA Vaccines And Therapeutics 2/19/2021

    mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of non-viral delivery systems.

  2. Bio4C ProcessPad™ 21 CFR Part 11 Compliance 1/12/2021

    Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.

  3. Chromatographic Purification Of Plasmid DNA 11/19/2020

    Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).

  4. How Pattern Search Finds Anomaly Patterns In Historical Machine Data 10/21/2020

    Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools. 

  5. Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis 10/14/2020

    A new platform that includes digital technologies/data management, process analytical technologies and intensified processing will drive next generation bioprocessing.

  6. Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective 6/22/2020

    This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.

  7. Cell Based Potency Assay In Functional Characterization Of mAbs 6/12/2019

    Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

  8. 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.

  9. 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.

  10. Data Utilization For Advanced Analytics And Near Real-Time Monitoring

    Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.