Search results for " biologics" in Articles / App Notes
Article
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
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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…
Article
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…
Article
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 …
Article
A Look into the Future of Biopharmaceutical Quality
Regulations
BioPharm: With the fast development of the biopharmaceutical industry over the past 30 years, how have quality regulations adapted to address the complex nature of biologics?
Ne…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
The rise of costly biologics over the past 20 years, however, has put greater pressure on downstream fill/finish operations to ensure that quality, safety, and cost efficiency are not compromised at t…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
N-Glycan Analysis of Biotherapeutic Proteins
In this article, the biological effects of N-glycosylation on protein biologics are reviewed—together with the range of analytical techniques that are used to elucidate the N-glycosylation characteris…