Search results for "biologic"
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
… 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 m…
Article
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…
Article
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,…
Article
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…
Article
Maximum Output Starts with Optimized Upstream Processing
Significant growth in the development and manufacturing of biologics—from traditional recombinant proteins and monoclonal antibodies (mAbs) to advanced multispecifics, antibody-drug conjugates, viral …
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
However, because biological materials—cell substrates and often animal-derived products—are used in their manufacture, viral vaccines and vectors are at risk of contamination from micro-organisms, suc…