Search results for " industry"
Article
Technologies and Practices Must Evolve to Meet Demand
Nearly two-thirds of those responding believe technology will evolve to permit full continuous manufacturing in five years; however, industry adoption may lag or the technology will be applied in sele…
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Ligand-Binding Assays and the Determination of Biosimilarity
“High-throughput, kinetic assessment of target binding on cells for those targets that cannot be produced as soluble proteins remains a challenge for the industry,” she observes. Several companies are…
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High-Throughput Process Development in an Historical Environment
The purpose of the Olympiad is to allow process developers to benchmark their internal HTPD workflows against peers in the biopharmaceutical industry and academy. The challenge in the very first HTPD …
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Read More Q&As With Industry Leaders Here
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Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Recombinant protein production in the biopharmaceutical industry mostly relies on fed-batch mammalian cell culture (1, 2). Often in fed-batch processes, the feed volume can be more than 1000 L for a 5…
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Manufacturers Struggle with Breakthrough Drug Development
It’s a sign of strong industry interest in developing new drugs with accelerated, abbreviated pathways, even if indicated for small patient populations.
Janet Woodcock, director of the Center fo…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
FDA, Guidance for Industry, Process Validation: General Principles and Practices, Revision 1 (Rockville, MD, January 2011).
2. ICH, Q8(R2) Harmonized Tripartite Guideline, Pharmaceutical Developme…
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Drugs, At What Cost?
The report identifies challenges, but also indicates opportunities for the industry to improve the lives of patients.
In 2012, developed markets (United States, Japan, Germany, France, Italy, S…
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Comparing Protein A Resins for Monoclonal Antibody Purification
Commercial-scale production challenges
The rapid growth in mAb demand has triggered industry efforts to increase manufacturing capacity, with the consequence that the antibody titers in mammalia…