Search results for " standardization"
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
This will lead to greater standardization in the future,” he adds.
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Roadmap Leads to Innovative Biomanufacturing Strategies
Frohlich: The first edition of the BPOG Biomanufacturing Technology Roadmap is already showing some progress and impact in simply acknowledging the need for some standardization in the industry. While…
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Efforts Accelerate to Streamline Postapproval Change Process
WHO Expert Committee on Biological Standardization, Annex 4 Guidelines on procedures and data requirements for changes to approved vaccines (Geneva, Switzerland, 2015).
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
What general trends do you see in single-use technologies within the biopharmaceutical industry?
We are now seeing standardization of materials testing data and corresponding analytical techniques…
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USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
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Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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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…