Search results for " clinical development"
Article
Witnessing Major Growth in Next-Generation Antibodies
A few have already been approved, and many more are in preclinical and clinical development. There are numerous challenges that need to be overcome first, however, and the full impact of next-generati…
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Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
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What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
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Mapping a Route for Cell and Gene Therapy Process Development
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
By Cynthia A. Challener
…
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Biopharma Advances Demand Specialized Expertise
Perhaps the greatest challenge is in clinical development of novel and originator molecules, where in-vitro model systems are still not a great predictor of clinical performance.
Rogers (SGS Life S…
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mAbs to Watch in 2016
Inotuzumab ozogamicin originated from a collaboration between Pfizer and Celltech, which is now UCB—but Pfizer currently has sole responsibility for all manufacturing and clinical development activiti…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…