Search results for " system"
Article
Brazil Emerges as Global Biopharm Collaborator
Brazil, however, plays a key role in the sector with a series of universities and institutes promoting research and development actions, a public health system capable of sustaining part of the local …
Article
Predicting Progress in Protein Aggregation
One such method is hydrogen deuterium exchange mass spectrometry (HDX MS), which enables the detection of potential sites of aggregation because they are systematically protected from solvent exposure…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
ICH, Q10, Harmonized Tripartite Guideline, Pharmaceutical Quality System (April 2009).
5. ICH, ICH Quality Implementation Working Group Points to Consider (R2), ICH-Endorsed Guide for ICH Q8/Q9/Q1…
Article
Operational Excellence: More Than Just Process Improvement
Monitoring the Environment
In addition, the site’s environmental monitoring (EM) results showed potential contamination, but because the results were segregated in the tracking system, personnel …
Article
The Development and Application of a Monoclonal Antibody Purification Platform
This was accomplished by performing previously defined experiments for each unit operation with specified ranges for buffer systems, load capacities, and pH/conductivity values. These experiments allo…
Article
The Future of Biopharma
…ducts, many with smaller niches
• more multi-product facilities
• adoption of single-use systems at clinical and commercial scale
• continuous processing, including perfusion
• high-t…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
FDA is currently pursuing additional pathways to ease postapproval changes for well-understood and controlled processes under a robust quality system.
Continuous manufacturing, althoug…
Article
Address the complexity of protein characterization
This presentation includes some examples on the use of Biacore™ surface plasmon resonance (SPR) systems for active concentration measurement, target binding, and describe how you can use these assays …
Article
Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
These drugs improve quality of life for our patients and reduce the burden on the healthcare system.
This trend towards higher concentration is a challenge for existing filters due to the higher p…
Article
From Bottlenecks to Breakthroughs: Mastering Buffer Management
- A case study presented by Johnson & Johnson Innovative Medicine to show how the installation of an inline conditioning system helps a manufacturing site to gain productivity.
Watch now