FEATURED ARTICLES

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• 5 Key Considerations For Companies Outsourcing Process Development

  Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.

• A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems

  One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

• PUPSIT As Part Of A Contamination Control Strategy (CCS)

  Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

• When Should Filter Validation Be Performed?

  Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

• Accelerating cGMP Production Using Rapid Tech Transfer

  A partnership between Cytiva and Teva Pharmaceuticals showcases tech transfer success through effective communication, diligent project management, and a wide range of expertise.

• Bridging The Skills Gap In Biopharma

  Employees must have the skills to effectively execute on process development and manufacturing operations. How do you ensure they are updated on complex bioprocessing techniques and technologies?

• Is Not Using A CDMO Slowing Down Your Process Development?

  Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

• Purifying Plasmid DNA Using A Modern Chromatography Resin

  Through an industry collaboration, Cobra and Cytiva were able to combine their expertise and experience and create a solution to meet the rising demand for high quality plasmid DNA.

• Best Practices For Efficient Bioprocess Technology Transfer

  A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility.