Search results for " attribute"
Article
Modern Manufacturing Key to More Effective Vaccines
Similarly, Cristiana Campa of GSK Vaccines in Italy emphasized that the complexity of vaccine development makes it important to define a control strategy for identifying critical quality attributes as…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA notes that the product has unique quality attributes that can directly impact final product safety and potency, and that several manufacturing failures occurred at Novartis facilities in the Unite…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
What could be the main reasons and/or the main drivers that hybrid bioprocessing are being used? Is there a difference between upstream and downstream?
If we look at the key benefits that are attr…
Article
Being Thorough When Transferring Technology
Therefore, the process controls that were identified and demonstrated during process validation studies to maintain consistent and reproducible manufacturing processes and product critical quality att…
Article
Reconciling Sensor Communication Gaps
Techniques that quantify some over-arching characteristic come to mind—such as refractive index in the chemical-pharmaceutical world—but the quality attributes for biopharmaceutical molecules are so m…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Enormous success achieved with mAbs can be attributed to their distinctive beneficial properties and advantages, which include high binding specificity and affinity, availability of humanized forms th…
Article
CMOs Concerned With Cost of Single-Use Equipment
Figure 2: Percentage point gap between importance of single-use systems (SUS) product attributes and level of satisfaction, select responses.
In any case, satisfaction with single-use pricing is…
Article
A Bright Future for the Plasma Fractionation Industry
Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Product Quality Attributes (PQAs) and Critical Quality Attributes (CQAs). Process risk analysis was…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
In such films, the attributes of each layer contribute to the overall properties of the film, and resin selection is based on criteria set for, for example, barrier properties or transparency requirem…