Search results for " industry" in Articles / App Notes
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
What is your view of HIC in the biotech industry today and its role in the future?
HIC is a powerful purification technique that is well established and will remain important in the future. It pro…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Breakthrough Drugs Raise Development and Production Challenges
And they indicated that additional resources from industry are warranted to support the unexpectedly large breakthrough program.
While FDA can quickly approve products with clear outstanding value…
Article
Host-Cell Protein Measurement and Control
Measuring and Monitoring Residual HCPs
To date, immunoassay, commonly in the form of sandwich enzyme-linked immunosorbent assay (ELISA) (see Figure 1), remains as the industry gold standard for HC…
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Continuous Chromatography: Trends, Definitions and Approaches
Read More Q&As With Industry Leaders Here
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Detecting Protein Aggregates and Evaluating their Immunogenicity
FDA, Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (Rockville, MD, August 2014).
Article Details
BioPharm International
Vol. 28, No. 3
Pages: 22-26 …
Article
Tackling Analytical Method Development for ADCs
“Cross-fertilization within the biopharmaceutical industry, particularly driven by the proliferation of ADC-focused conferences, workshops, instrument company webinars, etc., has lead to an increased …
Article
Labeling of Biosimilars
Regulatory issues
Nonetheless, there are a number of regulatory issues with biosimilars that parts of the pharmaceutical industry believe still need to be sorted out by EMA. The biggest of these is…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The use of disposable equipment in the biopharmaceutical industry is rapidly increasing, as it offers advantages in terms of flexibility, elimination of cleaning procedures, and reduced capital expend…
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What Drove Biopharma Development in 2014?
In fact, the monoclonal antibody market represents the fastest growing segment within the biopharmaceutical industry. The global monoclonal antibody market size exceeded $80 billion in 2013, and could…