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.

• 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.

• De-Mystifying, De-Risking Process Development With A CDMO

  An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.

• Utilizing External Collaboration To Accelerate Vaccine Development

  Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

• Making The Business Case For Vaccine Manufacturing

  Vaccines are absolutely crucial for maintaining global health, but are a challenge to develop and manufacture. How can businesses ensure profitability while providing low prices for developing countries?

• Can A Shared Biomanufacturing Facility Be The Answer To The Demand Forecasting Dilemma?

  Using a shared biomanufacturing facility, a biomanufacturer can minimize its investment while mitigating the risks of demand uncertainty and maximizing time to market.

• The Transparent CDMO: Maintain Autonomy In Biomanufacturing Partnership

  Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

• Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities

  By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.

• Modular Approaches For Diverse Molecules: Reinventing Smart Bioprocessing

  Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

• Roivant Accelerates Process Development To Speed Orphan Therapy To Market

  This case study shares the work of Cytiva’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.

• Collaborative Project To Accelerate Downstream Biosimilar Processes

  This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein.

• Biopharma's Talent Crunch: How To Gain And Retain Skilled Labor

  What strategies should your company consider for recruiting, training, and retaining qualified candidates in order to remain competitive in a burgeoning biopharma market?

• The Future Of Precision Medicine In China

  China is quickly becoming a world leader in biopharma, with rapid build-out of gene and cell therapy production capacity and a robust pipeline of drugs in development.

• Best Practices For Efficient Bioprocess Technology Transfer

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