FEATURED ARTICLES

• Virus Retention Performance Under Diverse Processing Conditions

  Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

• Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products

  Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.

• Cell Culture Media Filtration: Evaluating Cell Culture Performance

  Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.

• Achieve Higher Targeted Concentrations

  Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

• Elevating mRNA Manufacturing Toward GMP-Readiness

  The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.

• Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization

  Discover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.

• 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 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.

• 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.