Search results for " ICH"
Article
Managing Risk in Raw Material Sourcing
… training, corrective actions and preventive actions, and other operations, says Ohri, who adds that ICH Q7 and IPEC guidelines helped shape the company’s change-management process. “It is important …
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Application of Quality by Design to Viral Safety
In the broadest sense, this comes down to a minimum number of logs of clearance for different viral classes, based on the risk assessment outlined in ICH Q5A. Because every biopharmaceutical has a uni…
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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 …
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Drug Quality Key to Innovation and Access
An important new quality guideline on lifecycle management of pharmaceuticals (Q12) is moving forward slowly, and should complement the series of ICH quality standards developed to encourage manufactu…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
Article
Innovative Therapies Require Modern Manufacturing Systems
The organization now seeks more involvement of regulatory authorities and manufacturers in Asia, Africa, and the Americas in the ICH standards-setting process. FDA, the European Medicines Agency, and …
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Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…
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…