Search results for " biosimilar"
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 Prod…
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USP Publishes Monoclonal Antibody Guidelines
Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expa…
Article
Pharma Investments Reflect Key Industry Trends
In the biosimilar sector, the stiff competition will also keep volumes quite low, at least initially. There are approximately 100 companies worldwide looking to produce 5-7 of the most successful biol…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The data obtained from analysis of the CQAs of further batches or reference materials in parallel can be used to provide an assessment of comparability in terms of batch to batch or indeed biosimilar …
Article
Global Expansion Shapes Drug Oversight
…orts 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 …
Article
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…
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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…
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Evolution of the Monoclonal Antibody Purification Platform
With the advent of biosimilars and the related increased pressure on lowering the cost of production, it is likely that the next decade will see more significant changes in the platform.
Reference…
Article
Trends in Downstream Bioprocessing
Future developments are likely to result in more efficient bioprocessing that meet the needs of production in emerging regions, and permit cost-effective biosimilar manufacturing, as well as reduced o…