Search results for " approval" in Articles / App Notes
Article
Use of Multivariate Data Analysis in Bioprocessing
…milarity between innovator and their biosimilar version, the regulatory authorities may consider the approval of the drug for market authorization with minimal clinical studies data.
A quantitative…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Such approaches, the authorities predict, could reduce waste, prevent drug shortages, and avoid the scale-up and production challenges that can delay final approval of innovative breakthrough therapie…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
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
High-Throughput Process Development in an Historical Environment
Presentations, discussions, and information-sharing on modern bioprocess technology and high-throughput process development (HTPD) in an historical and culturally enriched environment is the essence…
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist t…
Article
Challenges and Trends in Biopharma Facility Design
This involves many aspects, from market as well as scientific and technological perspectives including:
• Product efficacy and approval--will it at all get to market?
• Market demand
• Siz…
Article
Evaluating Design Margin, Edge of Failure and Process
Design space is proposed by the applicant and is subject to regulatory assessment and approval.”
Design space is established through proper characterization techniques and is often an extrapolatio…