Search results for " documentation" in Articles / App Notes
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Going Small to Achieve Success on the Commercial Scale
“There is a lot of documentation and analyses to complete, so in essence, qualification of scale-down models is often an exercise in coordination, rather than presenting a substantial technical challe…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
“Investing in automated information management can also pay off,” he says, “where an electronic batch record system that is fully validated can enable release-by-exception, reducing error, documentati…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
“For this model to be successful, the facilities need to be identical in order to facilitate tech transfer, documentation, training, and essentially everything that needs to be commissioned to run the…
Article
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …
Article
Continued Process Verification for Biopharma Manufacturing
In its entirety, CPV includes: preparation of a written plan for monitoring a biopharmaceutical manufacturing process, regular analysis of results, documentation of the data collected, analysis of dat…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
EMA Invites Comments on New Guidance for Vaccine Development
The European Medicines Agency (EMA) has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical req…
Article
Challenges in Analytical Method Development and Validation
Proper documentation including import licenses, if necessary, should be obtained in advance. To ensure the success of method transfer, the analytical methods should be evaluated by the receiving labor…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…