Search results for " industry 4.0"
Article
Technologies and Practices Must Evolve to Meet Demand
Jan 01, 2015 By Rita Peters
Through Dec. 3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule …
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Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
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High-Throughput Process Development in an Historical Environment
Presentations, discussions, and information-sharing on modern bioprocess technology and high-throughput process development (HTPD) in an historical and culturally enriched environment is the essence…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementi…
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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
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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Drugs, At What Cost?
Generics, market dynamics, and global demand are changing drug spending patterns.
The underlying question for any drug in development is: What price can (or will) patients pay for the needed…
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Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …