Search results for " validation"
Article
Going Small to Achieve Success on the Commercial Scale
…anufacturing-related investigations, evaluation of changes in raw materials, and so on, barring only validation efforts and clinical trial/commercial manufacturing requirements for performance of lar…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
Using Single-Use Technologies in Downstream Processing
According to Nilesh Mehta, senior process engineer, Merck GTO, Sterile and Validation COE, “as new technologies become available or existing technologies are converted into a single-use format, the nu…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…
Article
A Bright Future for the Plasma Fractionation Industry
Christophe Carnewal presented their work on qualified small-scale models to reduce the number of conformance batches and a simplified regulatory submission for upscaling and process validation activit…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
…e identical in different locations, which again simplifies maintenance, documentation, training, and validation. “The modular nature of machinery makes modifying or adding options possible; their plu…
Article
Biomanufacturing Outsourcing Globalization Continues
opened its Life Sciences Centre of Excellence in Shanghai, which offers biopharma process solutions (CMO work), technical, and validation support as well as training (5).
Beyond China and India, L…