Designing Quality into Biomanufacturing

A Proactive Approach to Efficiency and Compliance

In our most recent article, Michelle Kneeland, Senior Scientist, and Miguel Carrion, VP of Business and Process Development at Tanvex, explain how Quality by Design (QbD) transforms biomanufacturing. QbD integrates quality into every stage of the process, from early development to final production, reducing product variability, improving scalability, and expediting regulatory approvals. Download the article to discover more.

Five Benefits of QbD in Biomanufacturing  
  1. Reduced Product Variability: By establishing a clear design space and implementing robust process controls, QbD helps minimize inconsistencies across batches, leading to higher-quality products and reduced waste.
  2. Improved Efficiency: The QbD framework enables better scalability and adaptability, allowing biomanufacturers to streamline production and reduce time to market.
  3. Regulatory Advantages: QbD aligns with FDA and ICH guidelines, facilitating smoother regulatory reviews and approvals, including Investigational New Drug (IND) and Biologics License Application (BLA) submissions.
  4. Enhanced Process Understanding: Tools like process analytical technology (PAT) and design of experiments (DOE) provide real-time insights into critical quality attributes (CQAs), enabling continuous process verification and ongoing improvements.
  5. Cost Savings: By mitigating risks and reducing batch failures, QbD significantly lowers overall production costs while improving quality control.

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