Search results for "analytical"
Article
Moving Biosimilars Forward in a Hesitant Market
However, Gabrielson clarifies, what most people don’t realize is that the amount of data from a CMC perspective, and particularly data demonstrating analytical similarity, is the same or higher than w…
Article
Good Manufacturing Practices: Challenges with Compliance
Second, ensure that you have a strong analytical team working with you, whether that’s internally or through a partnership with a CDMO. The equipment and methods for biologics analytical work are very…
Article
Improving Upstream Predictability
“Using automation, process analytical technologies (PAT), and advanced multivariate analysis has enabled the industry to control process performance and product quality more closely than ever before,”…
Article
Mapping a Route for Cell and Gene Therapy Process Development
This results in part due to the complexity of the product, but also due to a lack of analytical tools that can provide relevant information with sufficient sensitivity. There is also a need for approp…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
Article
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
unlimit3d/Stock.Adobe.com
Biomanufacturing proc…
Article
Understanding Validation and Technical Transfer, Part 3
The product specification includes tests, analytical procedures, and acceptance criteria defining the product and establishes the set of criteria for demonstrating the product is acceptable for its in…
Article
From Darwin to Recombinant Fc Multimers
… systems, Radial flow chromatography, Novel chromatography resins, Ukraine plasma market, and Novel analytical assays based on Surface Plasmon Resonance.
More than 20 posters were presented at…
Article
Critical Quality Attributes Challenge Biologics Development
BioPharm International spoke with Tapan Das, head of stability, methods and analytical development at Bristol-Myers Squibb and Finance Committee member and past-chair of the BIOTEC Section at the Amer…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Together, the presented strategy is integrated with other existing drug substance analytical control and product characterization strategies to ensure the integrity and consistency of the drug substan…