Search results for " patients" in Articles / App Notes
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Faster Flavivirus Vaccine Production
Viral vaccines need to be produced fast and in large quantities. Routine immunizations and preventive campaigns, like stockpiling in response to emergencies, involve millions of doses, and speed is es…
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
Article
Security of Supply
Getting high-quality biotherapeutics to patients on time requires a concerted effort. Working together, suppliers and manufacturers can better understand raw materials and variations that put processe…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
Preparing for the Future: Visions and Insights for Biomanufacturing
The biopharmaceutical industry has a reputation of being averse to change. Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targeting smaller patient populations,…
Article
CDMOs Driving Emerging Bio/Pharma Success
…e if they can be converted into physical products that can be safely and effectively administered to patients, and if that safety and efficacy can be demonstrated in clinical research. For that reaso…
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
nobeastsofierce/Shutterstock.com
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Article
Going Viral
How a new factory-in-a-box is helping scale up manufacturing of viral vector-based therapies to reach more patients.
Manufacturing viral vector-based therapies such as vaccines and gene…
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 |…