Search results for " QbD"
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Resource
Protein Science Week, San Diego, CA, USA
PepTalk: The Protein Science Week is your chance to hear from some of the most influential and thought-provoking speakers in the biotherapeutics industry.
Resource
Protein & Antibody Engineering Summit, Lisbon, Portugal
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering.
Resource
Integrated Continuous Biomanufacturing IV, Brewster (Cape Cod), Massachusetts
ECI’s Integrated and Continuous Biomanufacturing Conference (ICB) is the world’s premiere conference in the area of continuous biomanufacturing.
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
Article
Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
By Feliza Mirasol
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Poster
Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. Vi…
Poster
Perfusion Media Development for Scalable Processes
Cell culture perfusion processes are considered optimal for a truly integrated continuous biomanufacturing pipeline. The nutrient-rich but balanced media should be designed to support very low cell-sp…
Article
Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
With the mission of providing state-of-the-art education and training in the fast-emerging field of biopharmaceutical processing, the Jefferson Institute for Bioprocessing (JIB) formally opened its …