Search results for "bioprocessing"
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…
Article
Flexibility in Biopharmaceutical Manufacturing
The history of bioprocessing drug substances has been such that mono-facilities were built to produce large volumes of single blockbuster products. The business environment has changed and biofaciliti…
Article
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…
Article
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…
Article
PDA's Technical Report for Biotech Cleaning Validation
DEGRADATION EFFECTS
A key consideration in bioprocessing is that the active ingredient is usually degraded by cleaning processes that involve hot, aqueous, alkaline cleaning solutions. Although th…
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