Search results for "Adaptation"
Article
Technologies and Practices Must Evolve to Meet Demand
Jan 01, 2015 By Rita Peters
Through Dec. 3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule …
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.
By: Randi Hernandez
Whil…
Article
Continued Process Verification for Biopharma Manufacturing
FDA’s January 2011 process validation guidance emphasizes the need for companies to organize and use acquired knowledge and continually improve throughout the process lifecycle by making adaptations t…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
Following the 2009 outbreak of the H1N1 pandem…
Article
Evolution of the Monoclonal Antibody Purification Platform
Major Adaptations to the mAb Platform
Use of multiple washes in Protein A
To understand the resolution of fragments and aggregates on Protein A, a pH gradient elution between pH 5.0 and 3.0 over 1…
Article
Flexibility in Biopharmaceutical Manufacturing
Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanuf…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Production lines can more easily be modified for the manufacture of different products and the adaptation of production volumes to meet market needs is significantly facilitated. Furthermore, disposab…
Article
The Future of Biopharma
What the industry's future holds and what needs to be done to get there.
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation …