Search results for " methods"
Article
Using Multiple Techniques in Biosimilar Analysis
However, despite this recommendation appearing in both EU and US guidelines for comparability studies, it is still common to see methods being used under conditions that are unlikely to lead to differ…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Intense efforts in bioprocess development have been made to improve the production of CHO-based biopharmaceuticals by cell line engineering, improved methods for cell growth, and upregulating the post…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
MATERIALS AND METHODS
Monoclonal antibody (mAb-A, IgG1) formulation
The mAb-A formulation (64 mg/mL protein concentration) was prepared in a formulation that contained a buffering agent (10 mM…
Article
Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
Article
Modular Manufacturing Platforms for Biologics
Because the CMO business model may put more cost pressure on delivery, adds Emel, CMOs may “be willing to try newer methods or technologies if they have the possibility to reduce their initial capital…
Article
Quality by Design and Extractable and Leachable Testing
Not all extractables are leachables, but because it is not always clear which components could leach out under storage conditions likely to be encountered, methods are developed to detect the extracta…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
He adds that regulatory authorities recommend simple and reliable methods for the characterization of biosimilars, and LBAs are one type of alternative.
For drug substance/drug product testing, on…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.
The characterization of proteins involves identification of their complex …
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Outdated manufacturing processes and methods
There seems to be some hesitation from industry to update/improve outdated manufacturing processes and methods that pose quality risks, such as prod…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
…adyToProcess equipment, Application note 29-0435-49
• Microcarrier cell culture principles and methods, Handbook 18-1140-62