Search results for " molecular modelling"
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar
Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Mechanistic modeling is considered a part of smart process development, which is a collection of approaches to get better process outcomes and speed up process development.
This week, Bioproce…
Article
Utilization of Mechanistic Modeling to Improve Process Development
To follow the QbD paradigm and keep up with shorter timelines, process developers are evaluating different approaches to improve process development workflows and gain a better process understanding…
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
nobeastsofierce/Shutterstock.com
…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
…
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…