Search results for " comparability"
Poster
Scale-up and process economy calculations of a dAb purification process using ready-to-use products
Purification of a domain antibody (dAb) in a chromatography capture step was successfully scaled from laboratory to pilot scale using ready-to-use equipment and ready-made buffers. The scaled-up pro…
Poster
Scale-up of CHO fed-batch cultures in HyClone™ ActiPro™ medium supplemented with Cell Boost™ 7a and 7b
Comparing cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplement…
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Another FDA guidance, published in April 2016, encourages manufacturers to utilize comparability protocols, also known as PACMPs in the European Union, to outline planned future changes and how they w…
Article
Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
E. coli growth and Dab expression in single-use and stainless steel fermentors
This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process developed for a stainless steel …
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
Process Development Forum speaks with Professor Alois Jungbauer, Department of Biotechnology, BOKU, Vienna, about Hydrophobic Interaction Chromatography (HIC).
What is your view of HIC in the bi…