Search results for " drug"
Article
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
Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Otherwise, cell culture, purification, and drug product development may put undue importance on meeting certain criteria that are ultimately not critical, resulting in suboptimal processes that make u…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…y risk management (Q9), pharmaceutical quality systems (Q10), and the development and manufacture of drug substances (Q11) (1-4).
The international pharmaceutical companies in particular hav…
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Q&A with Industry Leaders: Rita Peters
Q: What trends have you seen in the drug development market as 2014 enters the second quarter?
A; At recent industry conferences and trade shows for pharmaceutical development, both educational se…
Article
Design of Experiments for Analytical Method Development and Validation
This approach applied to analytical methods is often not practical as 10-20 methods are often used for drug substance and drug-product evaluation and the amount of time and materials needed to follow …
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
As a technology that permits the generation of monoclonal antibodies against almost any target molecule, it immediately gained great interest as a source for potential drug candidates. Although it too…
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Jan Over from Sanquin gave an insightful presentation on orphan drugs. Orphan drugs are medicinal products for diagnosing, preventing or treating rare diseases, with a prevalence as low as 0.65 person…
Article
Prescribing Caution for Biosimilars
However, at a minimum, providing notice to the prescribing doctor and patient ensures everyone in the treatment continuum is informed of decisions to switch to a different biologic drug, either at the…
Article
In-person seminar: Manufacture of sterile medicinal products
Join us for a free in-person seminar focused on applications at the end of the bulk drug substance workflow including drug product applications.
Register and join us here for a free in-person semi…