Search results for "Adaptation" in Articles / App Notes
Article
Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
Article
Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Antibodies and related proteins comprise one of the largest and fastest-growing classes of protein pharmaceuticals. A majority of such molecules are monoclonal antibodies; however, many new entities…
Article
Selecting a Comprehensive Bioburden Reduction Plan
My view is that if a good risk assessment has been performed on one variety of biologic, then the framework would be suitable for a second type with the relevant adaptations.
Mittelman and Anicett…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
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…