Search results for " upstream" in Articles / App Notes
Article
Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …
Article
Using Single-Use Technologies in Downstream Processing
While the industry has used SUS in upstream processing for some time now, the use of single-use technologies is becoming popular in downstream processes as well. And it appears that the single-use tre…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
“Many of these processes were licensed long ago and are quite complex, contain open steps, and are inefficient in many places,” notes Parrish Galliher, CTO of BioProcess Upstream at Cytiva.
FDA has…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
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About the Authors
Sara Ullsten, PhD is bioprocess project manager; Eva Lindskog, PhD, is upstream marketing segment leader; Eva Blanck is research engineer; Shujian Yi, PhD, is senior polym…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
They are also very robust and meet development criteria, which is equally important because typically LBAs are developed by upstream analytical method development groups and subsequently transferred t…
Article
What Drove Biopharma Development in 2014?
In 2014, there was significant increased interest in continuous processing, both upstream and downstream. On the PDF site, this trend was evident based on webinar invitations, as well as in published …
Article
Securing the Single-Use Supply Chain
Large-scale impact
Today, single-use systems are used throughout the entire process chain from upstream to downstream and from bench scale to production scale. In the past, when drugs were manufac…
Article
Challenges of Protein Aggregation During Purification
While most aggregates are formed during upstream operations, and the risk for aggregate formation at the cellular level has increased as titers have increased, if unsuitable conditions are selected fo…
Article
Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
Simultaneously, it’s getting increasingly difficult to find the right talent—our study of global biopharma companies shows that finding qualified professional staff in upstream process development is …
Article
Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…