Search results for " biologics"
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
FDA Approves First Biosimilar
To date, there are a total of five 351(k) applications that are publicly disclosed, including the one for Zarxio, said Leah Christl, associate director for therapeutic biologics and biosimilars in the…
Article
Quality by design for biotechnology products—part 1
In summary, identifying the CQAs and setting appropriate specifications and acceptable limits (or validating removal if applicable) are the foundational activities of implementing QbD for biologics. T…
Article
Sterilization Trends for Single-Use Consumables
Staying abreast of and managing trends in sterilization of SU consumables is therefore essential for biologics producers.
Several sterilization process essentials
Contamination poses a huge risk t…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
For most biologics, therefore, sterility must be assured by using aseptic processing techniques, which involve use of sterile raw materials, equipment, and processes under conditions that prevent micr…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
Article
Nurturing Knowledge from Disparate Data Streams
Bigger challenges for biologics
Biologic drugs pose some additional challenges beyond those associated with chemical APIs. Small molecules have one structure and composition. Because biologi…
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Advances in Engineering of Protein-Based APIs
…hat they have significant practical limitations in therapeutic use, such as the inability to deliver biologics or peptides by oral administration. “One type of recent advance in peptide engineering h…
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Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …