Search results for " regulators"
Article
Drug Discovery and Development in India
Apr 01, 2015
By Jane Wan
BioPharm International
Volume 28, Issue 4
Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s …
Article
Tackling Analytical Method Development for ADCs
In addition, as more products make it into the clinic and then into the market, Jacobson expects that regulators will become more familiar, and more comfortable, with the ability of current analytical…
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…