Search results for " biomanufacturing"
Article
Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
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The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
Article
New Therapies Present Scaling Challenges
The cells must, therefore, keep their integrity and remain functional, two aspects that are challenged when the cell density in the biomanufacturing environment increases. As the number of cells rise,…
Article
Next Generation Bioprocesses: Mapping Roads to the Future
Increased productivity demand and a diversifying clinical drug pipeline have pushed the industry to explore new strategies and technologies in biomanufacturing. So what are next-generation proc…
Article
Cytiva and NIBRT Join Forces to Boost Talent Growth in Single-Use Bioprocessing
…raining and education curriculum, as well as co-develop a new curriculum designed to help the global biomanufacturing industry meet the needs of changing technologies and modalities.
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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…
Article
A Successful First Year for Testa Center
The bioprocess pilot-scale facility in Uppsala, Sweden, has hosted 15 national and international projects and more than 2000 study visits since its opening in 2018.
Testa Center, a not-for-prof…
Article
Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
Article
Tools and Processes for Mature and Emerging Therapies
New technologies and thought trends provide innovative biomanufacturing approaches for a range of therapies.
By Rita Peters
Conference sessions and new technology introductions at recent t…
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
Moving PAT from Concept to Reality
Springs, executive director of the Biomanufacturing Program at MIT.
Braatz adds that PAT provides increased production flexibility. “There is a lot of uncertainty about the market size when drugs …