Search results for " impurities"
Article
Biosimilars: Making the Switch Comes with Challenges
…al stages, for example by implementing the latest analytics and other imaging technologies to detect impurities and unacceptable differences in structures and functionalities.
The EU was the firs…
Poster
Unlocking the potential for efficiency in downstream bioprocesses
Downstream processes have to handle higher amounts of both targetprotein and impurities. So, in order to make full use of upstream advances in an efficient manner, it is essential that downstream proc…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Smart Bioprocessing has been chosen as the theme to emphasize the importance of understanding and controlling the origin of impurities, the impact of the production sources considered for the process,…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
ICH, Q3C (R5) Impurities: Guideline for Residual Solvents (ICH, Feb. 4, 2011).
10. M. C. Killilea, “Cleaning Validation: Viracept, 2007” IVT Network (Dec 3, 2012).
Editors’ Note: This articl…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need to be thought out clearly from the start, Hampson says, as well as indic…
Article
USP Stresses Pharmacopeial Standards at CPhI China
The USP requirements for elemental impurities, FDA’s metrics program, and the generic-drug market were also discussed.
USP stressed the need for compliance with global regulations and standards du…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Improving PAT for Biologics
The increased use of PAT for upstream processes is driven by the fact that most of the critical quality attributes of a product, the product yield, and the quantities of process-related impurities are…
Article
Trends in Single-use Bioreactors
• The issues of extractables and/or leachables and the potentially negative impact these impurities can have on specific processes
• The need for additional warehousing and associated logistics to…