FEATURED ARTICLES

• Regulatory Frameworks For mRNA Therapeutics

  The RNA therapeutics and vaccines market has grown rapidly, driven by siRNA and mRNA technologies. Explore how these advancements are now being applied to cancer vaccines and innovative therapeutics.

• Limiting Off-Target Effects Of CRISPR-Based Products

  Find out how to enhance CRISPR gene editing specificity by using Next Generation Sequencing to improve sgRNA quality control, addressing off-target effects and ensuring higher sequence fidelity.

• Building Local Biomanufacturing Capacity In South Africa

  Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

• mRNA Purification Using Anion Exchange Chromatography At Ambient Temperature

  Explore how anion exchange chromatography with dual gradient elution enables efficient mRNA purification at ambient temperature.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• Continued Process Verification: Driving Consistent Quality In Manufacturing

  Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

• Integrated Approach In Managing CPV And APQR

  Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

• Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development

  Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• 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.