Search results for " biologic" in Articles / App Notes
Article
Raw Material Variability
The biological molecule is often thought of as the value-adding element of drug substance, but unless the variability of each and every material that the cells come into contact during their creation …
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
mAbs are also extremely costly, and biologic versions are needed to maintain functioning healthcare systems, according to Theodor Dingermann, a professor and director of the Department of Pharmaceutic…
Article
Brazil Emerges as Global Biopharm Collaborator
The country’s impact, however, within the biological products market is limited to production and sales and does not necessarily include relevant innovations, according to Reinaldo Guimarães, intellec…
Article
Best Practices in Adopting Single-Use Systems
At the most basic level, materials must meet stringent biological and chemical guidelines. Bioprocessors should settle for nothing less than fully compliant materials from proven suppliers with establ…
Article
Supplier-Change Management for Drug-Product Manufacturers
These change notifications, when received, are evaluated to determine the impact on the manufacturing process for the drug or biologic product.
Change Notification Scope and Content
In general…
Article
Trends in Downstream Bioprocessing
Downstream processing involves the recovery and purification of protein therapeutics for biopharmaceuticals, vaccines, and other biologics. It involves the removal of insoluble cell debris and parti…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…