Search results for " biotherapeutic"
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…
Webcast
Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
Establishing a robust cell line is a critical step in the development of a biotherapeutic. But how can you meet rapid timelines when the cell line development workflow is challenged by documentation…
Article
Webinar: Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
Establishing a robust cell line is a critical step in the development of a biotherapeutic. But how can you meet rapid timelines when the cell line development workflow is challenged by doc…
Article
Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …
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
It seems, however, that contract manufacturers are being hit harder than biotherapeutic developers, perhaps because of their working with multiple products, and their clients’ demands for competitive …
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…