Search results for " information" in Articles / App Notes
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2012, the EMA also published final guidance, the non-clinical and clinical requirements for biosimilar mAbs, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficac…
Article
Design of Experiments for Analytical Method Development and Validation
Analyst name, equipment ID, out time, hold times, ambient temperature, temperature at the beginning and end of an operation, transfer times, pH, and incubation time may hold valuable information on fa…
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the jo…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Sources of information from other quality and manufacturing systems such as change control; scheduled preventive maintenance, calibration, or production interruptions; and customer complaints should b…
Article
Supplier-Change Management for Drug-Product Manufacturers
These deliverables may include, but are not limited to:
• Receipt of additional information from the supplier
• Execution of qualification studies or review of supplier validation summaries
…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
They are sometimes overly long, needlessly complex, and frequently do not provide the level of information needed to identify and resolve the root cause of the occurrence. Long scientific explanations…
Article
Essentials in Establishing and Using Design Space
Misconception Three: Edge-of-failure is needed for a design space
Failure mode experiments provide useful information, but are not required.
Misconception Four: Safe operating region…
Article
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…
Article
Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
(2005)
Ordering information
Related literature Code number
• Scale-up of adherent Vero cells grown on Cytodex microcarriers using ReadyToProcess equipment, Application note 29-0435-48
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