Search results for " control" in Articles / App Notes
Article
Ensuring the Quality of Biologicals
The use of materials of biological origin in medicine has a long history, and the quality control of biologicals has been in place for many years.
The Ph. Eur. began elaborating monographs on biol…
Article
Drug Discovery and Development in India
In December 2014, however, the NPPA announced that it will bring an additional 52 new drugs under price control. Consequently, drug makers have cut back on the number of medicines launched; data from …
Article
Labeling of Biosimilars
The laying of the legal foundations for the control of biosimilars over the past 14 years has given the EU global leadership in the regulation on the products, of which it had approved 19, including t…
Article
Trends in Single-use Bioreactors
In addition, there are improved control systems that allow multiple unit operation and sophisticated feed strategies improving cell yield and increasing titer with single-use bioreactors. Ergonomic fe…
Article
Gowning Practices Provide Clues to cGMP Compliance
Appropriate gowning
Is the protective clothing appropriate for the cleanliness level of the area? In production areas designed to be classified as controlled environments (i.e., designed using ISO…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Egg-vaccine technology limitations
Traditional vaccine manufacture begins with a “seed” virus identified and provided by the Centers for Disease Control and Prevention. This virus is introduced …
Article
Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
Article
Biotechnology Innovation and Growth in Israel
Historically, the high price of drugs has not been part of the public debate in Israel, and the government has rarely used price controls as is the case in other countries. However, recent economic st…
Article
Implementing QbD in Sterile Manufacturing
This is important to control the results of the former activities, as well as to identify and solve any existing problems prior to the start of the drug-manufacturing process. We primarily execute a d…
Article
ReadyToProcess WAVE 25 Bioreactor System
With ReadyToProcess WAVE 25, the rocking technology is enhanced with features such as advanced sensors and intelligent control strategies. System operation is easily managed via the intuitive and user…