Search results for " comparability"
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22:1383–91.
10. United States Pharmacopeia: USP/NF General Chapter 125. United …
Article
Being Thorough When Transferring Technology
…ogy transfer processes are critically important for biologics manufacturing, as the demonstration of comparability of biologics made at different phases of the drug-development cycle, at different sc…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change products are identical, but based on results and existing product knowledge, …
Article
Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Methods Accelerate Biosimilar Analysis
Identifying analytical methodologies that provide the necessary characterization and product comparability data in a shorter time can reduce the overall product development cycle time and, consequentl…
Article
Labeling of Biosimilars
Instead, a biosimilar has to demonstrate similarity to the reference product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exerc…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharm…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…