Search results for " 2018"
Article
Can Vaccine Development Be Safely Accelerated?
Young, “Rapid Response Pipeline for Stabilized Subunit Vaccines,” Presentation at the Vaccine Technology VIII Conference (June 2018).
9. University of Queensland, “Significant Step in COVID-19 V…
Article
Improving Upstream Predictability
Amgen, “Amgen Breaks Ground on Next-Generation Biomanufacturing Plant in Rhode Island," Press Release, July 31, 2018.
2. L. Bush, “Quality by Design mAb Case Study Challenges Conventional Thin…
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In 2018 alone, the U.S. FDA approved 17 biologics out of a total of 59 drugs—the highest number to date.
This article will delve into why the pharma industry is heading toward a biologics re…
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
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
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
…
Article
Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…