Search results for " variability"
Article
Advancing QbD in the EU
"These biological principles may display inherent variability," the new annex states. "As a result, QRM principles are particularly important for this class of materials." The annex includes a new sec…
Article
Evaluating the Use of Continuous Chromatography
…aphy contributes to increased consistency of product quality as well as better management of process variability. In addition, control of the downstream processing steps can lead to cost reductions (…
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
About this talk
Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics Presented by Irina Ramos, Director, Bioprocess Technology and…
Article
A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…
Article
Moving Biosimilars Forward in a Hesitant Market
Dealing with challenges
Other hurdles to bringing a biosimilar to market include the availability of the reference biologic and the batch-to-batch variability of that reference product; this is on t…
Article
Chromatography innovations for the diversified antibody pipeline
Introducing MabSelect™ VH3 affinity resin for antibody variants
At Cytiva, we connect with process developers and manufacturers to understand their needs and strive to make t…
Article
Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
Development beyond traditional monoclonal antibodies (mAbs) is increasing, and today, we see antibody variants like multispecific and bispecific antibodies and antibody fragments. In mAb proc…
Article
Determining and Optimizing Dynamic Binding Capacity
Dynamic binding capacity (DBC) indicates the quantity of a specific biomolecule that can be bound during a chromatography purification step under a specific set of process conditions. Determ…
Article
Report from the 12th Plasma Product Biotechnology Forum
The general trend was considered more interesting than specific values predicted, as scale-up and variability of analytical methods were not considered.
Another aspect of technical development …