Search results for " monoclonality"
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
Article
Optimizing KiH bispecific antibody chromatography steps
Bispecific antibodies (bsAbs) are a promising class of therapeutic agents due to their ability to bind to two different types of antigens or two different epitopes on the same antigen. This a…
Article
Evaluating the Use of Continuous Chromatography
Continuous processes continue to advance in bioprocessing. In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharma…
Webcast
Webinar: Intensifying Downstream Bioprocessing With Continuous Technologies
Significant operational improvements can be achieved by intensified continuous processes compared to standard batch processes.
In this webinar we will explore common bottlenecks in downstream pr…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
Article
Webinar: Intensifying downstream bioprocessing with continuous technologies
Webinar on June 20, 2024
Significant operational improvements can be achieved by intensified continuous processes compared to standard batch processes.
In this webinar we will explor…
Article
Purification strategies for antibody-derived entities: bispecifics and fragments
The diversity of antibody variants in today’s pipeline presents unique challenges for purification. Purification platforms used for many monoclonal antibodies (mAbs) need to be adopted for ant…
Article
Guide for selecting affinity resins for mAbs, bsAbs, and antibody fragments
Development of antibody-derived molecules are increasing. Today, molecules such as bispecific antibody (bsAb) and antibody fragments such as Fab, scFv, and VHH are seen in labs all over the w…
Article
A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…