Search results for "continuous"
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
At network level, particularly larger companies that have absorbed other companies and comprise multiple legacy facilities, adaptability to reconfigure networks has become an ongoing and continuous ac…
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
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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
RISK MANAGEMENT AND ASSESSMENT
Quality risk management (QRM) involves elements of risk assessment, risk control, and periodic review to ensure continuous and effective control (6). It is important…
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