Search results for " industry" in Articles / App Notes
Article
Biosimilar Quality Requirements
…he guidance Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry (2).
Congress created an approval pathway in the Biologics Price Competition and Inno…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
Article
Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
In addition to open enrollment courses, JIB also offers customized training to meet industry needs with specialized courses developed with companies and delivered either at JIB or the company site. JI…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
However, the industry is also exploring new approaches that would move testing and monitoring of CQAs out of the lab.
As part of the BioPhorum Operations Group’s (BPOG’s) Biomanufacturing Technol…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Hindrance or help?
Many disposable chromatography columns meet cGMP and industry standards, and also offer reproducibility, scalability, speed, ease-of-use, and operational safety.
However, chr…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Although the deployment of statistical models in industry is increasing at an accelerated pace (49), the use of mechanistic glycosylation models remains to be widespread. This disparity may arise from…
Article
Understanding Validation and Technical Transfer, Part I
…Canada, Switzerland, Brazil, China, and the Republic of Korea, and representatives of pharmaceutical industry organizations, has published a series of documents that, among other things, relate to pr…
Article
Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Korea, Japan, and Singapore, in particular, have a well-established biopharma industry with development and manufacturing capabilities that compete with businesses in North America or Europe at eye le…
Article
FDA Framework Spurs Advanced Therapies
One such approach involves the use of common manufacturing protocols within academia and industry to allow the sharing of clinical trial data.
The framework also implements the Regenerative Med…
Article
Process Chromatography: Continuous Optimization
Process development scientists must also balance multiple factors when developing new processes to address current challenges and industry demands. “Capacity, resolution, and the speed at which the pr…