Search results for "antibody"
Article
High-Throughput Process Development in an Historical Environment
A new session this year was the HTPD Olympiad, for which five teams had signed up to develop a purification process for a domain antibody (Dab). The challenge was to use HTPD workflows for maximized D…
Article
Challenges and Trends in Biopharma Facility Design
We have designed a turnkey modular factory, KUBio, which offers a monoclonal antibody manufacturing factory within 14-18 months and is pre-designed to support achieving cGMP requirements.
For biop…
Article
Challenges in Analytical Method Development and Validation
While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technologies for monoclonal antibody products, new molecules and drug conjugates pose additio…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
…te antigen-specific, balanced, cellular (for clearing virus-infected and cancer cells) and humoral (antibody-mediated) immune responses, according to president and CSO Rajan George. As a result, the …
Article
QbD and PAT in Upstream and Downstream Processing
Some of these CQAs, such as glycoxylation pattern for monoclonal antibody (mAb) products, are primarily impacted by the upstream process and are particularly important to monitor during process develo…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
Article
Address the complexity of protein characterization
Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant clinical success and have been used to provide effective treatment for a range of diseases. Durin…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Innovations in Perfusion Bioprocessing
In this study, we present a method for deriving perfusion culture media by leveraging existing fed-batch media and feeds.
Furthermore, we illustrate the successful transfer of the develop…
Webcast
Webinar: Intensifying Downstream Bioprocessing With Continuous Technologies
In this webinar we will explore common bottlenecks in downstream processing and look at continuous processing solutions that can further intensify the monoclonal antibody (mAb) platform.
We will di…