FEATURED ARTICLES

• Doubling Up For Speed In Biomanufacturing

  Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.

• CDMO Or No CDMO... That Is The Question

  Success depends on assessing internal capabilities and knowing when outsourcing can accelerate timelines. Learn how strategic decisions reduce risk, avoid costly delays, and keep your organization competitive.

• Choosing The Best mRNA Manufacturing Strategy

  Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.

• How To Reduce Batch Loss In Biopharma Production

  Batch failures in biopharma remain costly despite improvements. Learn the leading causes in downstream purification and how supplier expertise can help reduce risk and protect production.

• CDMOs - Key Collaborators In Streamlining Drug Development

  Accelerating biologics development requires more than speed. Discover how the right CDMO partnership can streamline processes and help you reach the market faster without sacrificing control.

• 5 Reasons For Outsourcing Chromatography Resin Lifetime Studies

  Outsourcing resin lifetime studies accelerates timelines, reduces costs, and minimizes risk. Gain expert support, free up resources, and optimize resin performance without tying up your team or equipment.

• Is Your Biologics CDMO Transparent?

  Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.

• How To Double Up With A CDMO To Reduce Risk

  Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.

• Biologics CDMO: 3 Qualities Often Overlooked

  A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.

• 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.