Search results for " biotherapeutics"

Article N-Glycan Analysis of Biotherapeutic Proteins
More than half of all biotherapeutics are glycosylated (2), including monoclonal antibodies (mAbs), Fc-fusion proteins, clotting factors, and cytokines such as erythropoietin. Of these, mAbs represent…

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Compared to the traditional small-molecule (pharmaceutical) drugs, biotherapeutics are complex and have the ability to bind to more than one target molecule. Biosimilars provide a more affordable trea…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Other raw materials used in the manufacture of biotherapeutics, especially those of animal and human origin, could also present a viral safety risk. Traditionally, the management of inadvertent vi…

Article Basics in Process Development for Biotherapeutics
Click here to learn more >> Definitions, activities, and things to consider when developing an upstream or downstream bioprocess.

Article Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
Click here to download the white paper now >> The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…

Article Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification. By Eric S. Langer Downstream processing continues to be a significant pain poi…

Article Reimagining Affordable Biosimilars
While effective and successful, biotherapeutics are presently marred by their high costs, which make their affordability poor for most of the world and thereby limit their accessibility. The adv…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Bispecific and multispecific antibodies constitute a growing area of biotherapeutics. Improving the assessment and understanding of multiple binding sites will be important to understanding their mech…

Article Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com Leveraging automation and a step-by-step approach are keys to success. By Cynthia A. Challener Cell lines determine the performanc…

Article Preclinical Evaluation of Product Related Impurities and Variants
Despite their success, the adoption of biotherapeutics is marred by issues around affordability as well as risks associated to the challenges in assessment of their safety and efficacy arising from th…

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