Search results for " Scale-up" in Articles / App Notes

Article Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work? Jeanne Linke Northrop, BioPharm International Nora Ketterer, Manager, Modeling Services…

Article Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality. Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…

Article Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics. In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…

Article Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development. The adoption of single-use systems in biopharmaceutical production or…

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. A…

Article Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics. Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…

Article Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends. With the dawn of the 2…

Article A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science. Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

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