Search results for " design" in Articles / App Notes
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Examples of such tools include high throughput process development, computational fluid dynamics, and use of advanced statistical approaches for designing experiments, analyzing data, and process cont…
Article
Single-Domain Antibodies for Brain Targeting
Identification and design of mutations that minimize the hydrophobic interface and direct selection from phage libraries have contributed greatly towards overcoming solubility and stability problems (…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In the concentrated feed medium study, the original concentration is designated as 1X. The 1X medium was used as a control. Feed media with concentrations of 1X, 1.30X, 1.60X, 1.75X, 1.90X, and 2.50X …
Article
Global Expansion Shapes Drug Oversight
…tation on quality-by-design (QbD) components to new drug applications and supplements, an initiative designed to provide consistency and clarity to QbD policies.
At a London meeting in April, …
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Comparable rates of growth are also seen with outsourcing of design of experiments (from 21.4% to 43.2%) and quality-by-design (QbD) services (from 19.3% to 42%). These activities are still at the bot…
Article
Bioprocessing Advances in Vaccine Manufacture
With advancing SUS technology, better plastics and new designs are being developed using SUS (vs. stainless steel) for their application in precommercial R&D, clinical-trial-material supply, and comme…
Article
Trends in Downstream Bioprocessing
• Current downstream/purification areas were not designed to handle this increase in production.
• Buffer capacity, column size, UF membrane area are all problems.
• Primary clarification is a…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
All purification steps were optimized by Design of Experiments (DoE), thereby supporting a Quality by Design (QbD) approach.
Using Capto L, Capto MMC ImpRes, and Capto adhere ImpRes media in …
Article
Prescribing Caution for Biosimilars
Briefly stated, these principals are:
•Substitution should occur only when FDA has designated a biologic product as interchangeable
•The prescribing physician should be able to designate a pre…
Article
Considerations in depth filter scale-up
Recent work has highlighted the importance of how capsule design can affect scalability of depth filters. In this work, we present scalability data across a full range of process development-scale, pi…