Resources
Process Validation Without the Guesswork: Leveraging Digital Models for Smarter Decisions
In the highly regulated and technically demanding world of biopharma, pharmaceuticals, and specialty chemicals, process validation is a critical milestone in bringing a product to market. It ensures that a process is not only effective and reproducible but also compliant with strict regulatory standards. Traditionally, achieving this level of confidence has required significant time, resources, an...
Increase Efficiency For mAb Downstream Operations
In the pharma industry, maintaining protein stability during final formulation is critical ensuring product efficiency and consistency. A leader in the animal health industry facing challenges during the dilution step of the fill finish process, where mechanical shear posed a risk of protein aggregation and denaturation - threatening both batch reliability and regulatory compliance. To address thi...
Monitor Bioreactor Process Health
Detecting early signs of process drift in commercial bioreactors remains a major hurdle for biopharma manufacturers. Traditional monitoring systems—often limited to empirical trends—frequently miss subtle deviations in complex biological systems, resulting in inconsistent product quality and delayed response times. With support from the tech experts at Tridiagonal Software, The upstream process de...
Accelerate Mammalian Cell Culture
A leading biopharma company faced significant challenges during technology transfer involving mammalian cell culture processes across sites using single-use bioreactors of varying volumes. With only a limited number of batches available for optimization, achieving consistent viable cell density (VCD) across scales became a critical concern. To address this, tech experts at Tridiagonal Software app...