Search results for " biopharms"
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
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Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
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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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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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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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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
Article
The Future of Biopharma
What the industry's future holds and what needs to be done to get there.
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation …