Quality White Papers & Case Studies

1. Client Story: Efficiency Enabling CSV At Scale 7/1/2025

   Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

2. How To Adopt CSA For Streamlined Computer System Validation 7/1/2025

   Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

3. N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit 6/30/2025

   Discover a company that tripled productivity and cut costs by optimizing its seed train process to achieve major gains without infrastructure expansion.

4. Modular Facilities With Smaller Footprint Through Dynamic Perfusion 6/30/2025

   Discover how a top CDMO leveraged dynamic perfusion technology to boost biomanufacturing throughput, cut capital costs, and enable flexible, multi-modality production.

5. Merck Process Transfer And Scale-Up Of Batch Protein A 6/30/2025

   Explore cost-saving innovations in purification using a system that achieves consistent product quality and yield while significantly reducing resin use and enhancing large-scale efficiency.

6. Success Story: Increased Productivity With Concentrated Fed-Batch 6/30/2025

   Discover how a leading biopharma company boosted flexibility and quadrupled productivity by implementing a concentrated fed-batch process in a single-use facility.

7. Improved GLP-1 Receptor Agonist Peptide Recovery 6/30/2025

   Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.

8. Development Of Separation Methods For GLP-1 Synthetic Peptides 6/30/2025

   Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

9. Leverage Apps To Reduce Line Changeover Time From 14 Days To 3 6/26/2025

   A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

10. Optimal Microbial Sampling Criteria 6/24/2025

    Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.