Search results for " control" in Articles / App Notes
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Coherent policies and procedures should describe precisely how the careful control of facilities, equipment, and materials will be used to prevent unacceptable exposure to animal-sourced materials. Us…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Provided is a comprehensive, risk-based transgene characterization strategy; its implementation is based on chemistry, manufacturing, and control (CMC) development phases to ensure that the integrity …
Article
Applying GMPs to the BioPharma Supply Chain
At an operational level, it is vital that biopharmaceutical production is carefully controlled within defined parameters and there is no possibility of contamination. Suppliers share a commensurate re…
Article
FDA Seeks Metrics to Define Drug Quality
Most obvious are reports of company recalls, poor inspection outcomes, and adverse events that are visible to FDA and can indicate broader deficiencies in manufacturing process and control strategy.
…
Article
Sterilization Trends for Single-Use Consumables
Three key trends: capacity, complexity, and process control
The increasing use of SU technologies for biologic drug manufacturing has led to the biggest recent trend related to sterilization of SU c…
Article
A Look into the Future of Biopharmaceutical Quality
Quality Control Unit Advancements
BioPharm: How do you see the role of the quality control (QC) unit changing in the coming years?
Newcombe (PAREXEL): I would not anticipate any significant…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
This resulted from the introduction of parental cell lines better suited to modern fed-batch processes and the development of better bioreactor processes, including control strategies for pH, carbon d…
Article
Automating Bioprocesses
The process control and automation requirements of SUS also differ from those of stainless-steel equipment. BioPharm International spoke with Michalle Adkins, director of Life Sciences Consulting, and…
Article
Improving Process-Scale Chromatography
Cytiva therefore offers several options to help improve data management, increase unit operation integration, and provide comprehensive control.
Implementation of single-use technologies
As fo…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
While one risk source may effectively be transferred outside, the internal focus then turns toward ensuring comprehensive controls are in place for ensuring vendor quality and continued supply.
Ri…