Search results for " UV detection"

Article HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time. ABSTRACT Monoclonal antibodies represent a significant portion of sales in the biopharma…

Article Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals. By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…

Article Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important. By Mostafa Eissa The biopharmaceutical industry has witn…

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 Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge. By Thomas A. Little, PhD To control the consistency and quality o…

Article Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed. Jul 01, 2015 By Susan Haigney BioPharm International Volume 28, Iss…

Article Optimization of Protein Expression in Escherichia Coli
May 01, 2015 By Siavash Bashiri, David Vikström, Nurzian Ismail BioPharm International Volume 28, Issue 5 Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…

Article Tackling Analytical Method Development for ADCs
Free drug issues are typically monitored using reverse-phase chromatography with UV detection, or if the levels of detection must be very low, using LC-MS/MS against a drug linear curve, according to …

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