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WHITE PAPERS AND CASE STUDIES

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• Advancing Drug Development With Optimized LC-MS/MS Bioanalysis

  Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.

• Novel Platform For Execution Of Pragmatic Studies Boosts Cancer Trial Efficiency

  Learn how Flatiron partnered with Genentech and Foundation Medicine to develop a novel platform for the execution of pragmatic studies.

• Digital Maturity In Life Sciences Quality And Manufacturing

  Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Lean Six Sigma Methodology Drives Cost Savings: 2 Success Stories

  Unlock significant lab efficiency and financial gains. See how focused optimization of workflows and asset management led to substantial cost savings and reclaimed six-figure value in consumables.

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• 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.

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• Generation Of Stable CHO Cell Lines For Protein Production

  By following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.