Search results for " regulatory"
Article
A New Paradigm in Process Development
Accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies. Download this e-book for case studies and insights from Janssen, Roivant Sciences, and mAbxience.
Click here to downl…
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
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…
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 …
Article
Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…
Article
The Value of Digital in Biopharma
To be successful in making targeted therapies, biopharma manufacturing must evolve into smaller, faster, and more efficient environments. Digital technology and data science can be leveraged to add …