Search results for " trends"
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
Article
Antibody Production in Microbial Hosts
coli,” in Current Trends in Monoclonal Antibody Development and Manufacturing, S.J. Shire, W. Gombotz, K. Bechtold-Peters., and J. Andya, Eds. (Springer New York, 2010), pp. 295–308.
31.…
Article
Use of Multivariate Data Analysis in Bioprocessing
Streefland, Trends Biotechnol. 32 (6), pp. 329-36 (June 2014).
5. S. Charaniya, W.-S. Hu, and G. Karypis, Trends Biotechnol. 26 (12), pp. 690-9 (December 2008).
6. N. Abu-Khalaf, S. Khayat, an…
Article
SEC in the Modern Downstream Purification Process
If vaccine manufacturing becomes decentralized to locations throughout the world, as current trends imply, disposable or single-use technologies may be a significant driver. This is not to say that ma…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
What trends can you identify in QbD?
Dr. Rathore: With respect to major trends, here are some that I see occurring at present. First is the industry’s interest in mechanistic modeling of biotech u…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Rathore, Trends Biotechnol. 27 (12) 698-705 (2009).
3. A. S. Rathore and H. Winkle, Nature Biotechnol. 27 (1) 26-34 (2009).
4. A. S. Rathore, Trends Biotechnol. 27 (9) 546-553 (2009).
5. I…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Trigger events such as single out-of-control points, oscillations, trends, and mean shifts do not necessarily suggest a risk to quality or require immediate corrective actions. They may also provide l…
Article
Evaluating the Use of Continuous Chromatography
Progression of Continuous Downstream Processing of Monoclonal Antibodies: Current Trends and Challenges. Biotechnology and Bioengineering 2018, 115 (12), 2893–2907. DOI: 10.1002/bit.26812
3. …
Article
Boosting biopharma resilience: The need to shift focus and increase collaboration
Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength an…