Search results for " safety" in Articles / App Notes
Article
Fundamentals of Viral Clearance Studies with a Focus on Chromatography
These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatog…
Article
Supply Chain Challenges for Single-Use Systems
More attention is being paid to sterility and integrity of connections and valves and minimizing the need for operator interaction, which has a proven impact on time and safety of processes.
Isber…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
The Challenge of Disruptive Technologies in Bioprocessing
“It is important to think about the biomanufacturing strategy early in the process to realize implications for flexibility, economics, safety, and logistics,” she says.
“Various operational cha…
Article
CDMOs Driving Emerging Bio/Pharma Success
…rted into physical products that can be safely and effectively administered to patients, and if that safety and efficacy can be demonstrated in clinical research. For that reason, CDMOs and contract …
Article
Making the Move to Continuous Chromatography
“This approach also allows a chromatography step to be run with less safety margins than would normally apply in a traditional batch process without loss of product,” she says.
Some systems com…
Article
Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
We want to focus on the ones that relate to the functional characteristics of exosomes and how they might behave from a safety and efficacy standpoint in the clinic. For exosomes, what you look at is …
Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…