Quality White Papers & Case Studies
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.