Search results for " productivity" in Articles / App Notes

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Best Practices for Selecting a Top-Quality Cell Line
Before scaling up to bioreactors, the productivity level for monoclonal antibodies (mAbs) should be 2–7 g/L (fed-batch culture in shake flask) or greater, observes Selexis CEO Igor Fisch. Once scaled …

Article Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches. By Cynthia A. Challener For a vaccine to be effective, the components of the disease o…

Article Managing Biomanufacturing Capacity Expectations
The authors concluded, “The key to unlocking the cost and capacity savings of concentrated fed-batch is increasing the specific productivity of the process through cell line and process development.” …

Article Ensuring the Quality of Biologicals
May 02, 2015 By Stephen Wicks, PhD Pharmaceutical Technology Volume 39, Issue 5 The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …

Article Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe. Feb 01, 2015 By Sean Milmo BioPharm International The European Medicines Agency (EMA) has r…

Article Pharma Investments Reflect Key Industry Trends
First is the shift to biologic-based drugs, which has occurred along with a dramatic increase in the productivity, mainly in terms of much higher titers, of biopharmaceutical processes. “While demand …

Article Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities. By Feliza Mirasol …

Article Understanding Validation and Technical Transfer, Part I
Scherkenbach, The Deming Route to Quality and Productivity Road Maps and Roadblocks, p. 145 (CEEPress Books, George Washington University: Washington, D.C., 1986).

Article Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product. Feb 01, 2015 By Anthony Grilli BioPharm…

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