Search results for " safety"
Article
Improving Upstream Predictability
This environment, in turn, results in more consistent drug product with an improved safety profile,” says Verlenden. Single-use bioreactors at commercial scale (i.e., 2000 L) have become standard, he …
Article
2019’s Top Bioprocessing Trends and What to Expect in 2020
… referenced Bioprocess Development Forum’s article on the basics of assessing viral safety when validating a biomanufacturing process with a focus on chromatography, as well as another article on chr…
Article
Biosimilar Quality Requirements
To demonstrate interchangeability, a sponsor typically sets up switching studies to show that the risk of safety of diminished efficacy from switching between the proposed interchangeable product and …
Article
Using Software in Process Validation
and requires a team effort that encompasses people from various disciplines within the plant?
It is important to design processes that ensure product quality, safety, and efficacy. Today’s soft…
Article
Driving Improved Access to Biosimilars
Almost a year after FDA formally issued its Biosimilars Action Plan (3), with the challenging goal of balancing patient safety with innovation, the spring and summer of 2019 brought several US congres…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
Article
Getting it Right from the Start in the Drug Development Process
As a result, the desired therapeutic outcome is achieved without compromising patient safety or introducing dangerous side effects.
Both upstream processing and downstream processing can affec…
Poster
Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
These studies are an essential part of process validation and are critical to ensure drug safety. Viral clearance studies are usually performed using a scale-down model mimicking the large-scale proce…
Article
Moving PAT from Concept to Reality
“That would require data sharing and access that implies safety risks. We experience reluctance among our customers to adopt new technologies such as cloud computing and wireless communication of PAT …
Article
Emerging Therapies Test Existing Bioanalytical Methods
Since 1990, due to improved understanding of the human genome, proteome, and immune system along with improved drug delivery processes, the safety, efficacy, and applicability of cellular and gene the…