Search results for "Biosimilars" in Articles / App Notes
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
One sign of progress was the opening of a JHL Biotech flexible manufacturing facility in Wuhan, China on May 10, 2016, for the manufacture of biosimilars and monoclonal antibodies (mAbs). The facility…
Article
Continuous Processing for the Production of Biopharmaceuticals
With the growing demand for biosimilars and an ever-increasing pressure for reduction in manufacturing costs, the biotech industry seems to exhibit a flourishing interest in the development of continu…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
…range of biotech therapies in development or under review by the agency, including orphan drugs and biosimilars that raise new analytical challenges. OBP now has four Divisions of Biotechnology Produ…
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
Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.
Aug 2, 2014
By: Cynthia Challener, PhD
Pharmaceutical Technology
Volume 37, Iss…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Global Expansion Shapes Drug Oversight
…rts to leverage each other’s inspection resources; collaboration to support global development of biosimilars; pediatric cluster meetings to encourage more common policies for pediatric studies and a…
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Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
There is a clear link between a country’s rate of economic development and the strength of its intellectual p…
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Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
Article
Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…