Search results for "biologic"
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
…cularly those governing data protection, patents, and trade secret protection--that are relevant to biological products.
Protecting IP, leveraging risk
The biotechnology industry is a dyna…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Several white papers will be discussed covering both small molecules and biologics. Professor Charles Cooney and I will be presenting the white paper on continuous bioprocessing.
The transit…
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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…
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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…
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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…
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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…
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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…
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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…
Resource
FDA’s Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biolog…