Search results for " biologic"
Article
Emerging biopharma: progressing a biologic drug to market
There are many pitfalls in the road to developing and bringing a new therapy to market. Understanding some of these areas and being prepared to make the right decisions at the right ti…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
Resource
Recovery of Biological Products XIX Conference
This international conference—taking place from July 12–17, 2020 in Rome, Italy—provides exposure to the latest developments in bioprocessing with a focus on downstream processing and aspects that aff…
Article
Being Thorough When Transferring Technology
By Susan Haigney
Editor's note: The following is an extended version of the article published in the print version of BioPharm International's March 2017 issue:
Tech transfer and scale up of b…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
The goals behind the safe and regulated introduction of biosimilars into the market include increasing access to much-needed biologic medicines and reducing costs (2).
A recent report (3) from …
Article
QbD and PAT in Upstream and Downstream Processing
…g Rathore, professor, Indian Institute of Technology (IIT) Delhi; Frederic Girard, CEO, Spinnovation Biologics; Thomas J. Vanden Boom, PhD, vice-president, global biologics research, development and …
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Continuous Manufacturing: A Changing Processing Paradigm
While only a few approved biologic products in the market—less than 10%, according to estimates by Eric Langer, managing partner, BioPlan Associates—are manufactured through perfusion or continuous do…
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The Bullish Outlook for Biosimilars
Most importantly, a number of patents are set to expire on leading biologics, and financially strapped payers across the globe are anxious to embrace biosimilars and their promise of cost savings. Yet…
Article
Biopharma Advances Demand Specialized Expertise
Lively, PhD, director of biopharmaceutical services, PPD; Scott Lorimer, VP Global Operations, Patheon Biologics; Eugene McNally, PhD, executive director, PPD Consulting; Rekha Patel, global director,…
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Good Manufacturing Practices: Challenges with Compliance
Cohen (Lubrizol): There are various regulations and guidelines around the world regarding the manufacture of biologics, which include information about control of feedlots and cell lines. These addres…