Search results for " regulators" in Articles / App Notes
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
Article
Setting Standards for Biotech Therapeutics in India
Unlike a lot of developing and developed countries, the standards stated in the IP are authoritative and legally enforceable by the Indian regulatory authorities (CDSCO and State Drug Regulators). In …
Article
Application of Quality by Design to Viral Safety
Therefore, discussions with the regulators early and often in the drug development cycle may help define the details of this CQA and the steps necessary to achieve success.
Multiple unit operation…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
In brief, this will continue to be an area of interest for the industry, the academia, and the regulators.
Read More Q&As With Industry Leaders Here
Article
Evaluating Design Margin, Edge of Failure and Process
The intended design space and how it is to be used within a controllable range should be clearly communicated to regulators. FDA generally welcomes discussion on design space with applicants; discuss …
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
This is also consistent with guidance from regulators, who encourage firms to view attributes as lying along a “continuum of criticality,” in which attributes warrant different degrees of control depe…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Trends in BioPharma Approvals in 2013
Biosimilars
While the advent of approved biosimilar products remains a future prospect in the US, European regulators…
Article
Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
Article
EMA Collaborates with HTA Assessment Networks
An European Generic Medicines Association (EGA) survey of national regulators in the EU pinpointed a number of obstacles to the uptake of biosimilars, including a perception of biosimilars being infer…