Search results for " 2016" in Articles / App Notes
Article
Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…
Article
Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Lessons Learned Accelerate Vaccine Development
Teamwork and multi-tasking at Janssen
Janssen Vaccines, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, received the 2016 Facility of the Year Award for Project Execution for it…
Article
Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Antibody Production in Microbial Hosts
With more than 200 recombinant proteins on the market today, the biopharmaceutical industry is expected to reach approximately $180 billion by 2016 (1). Therapeutic mAbs and their derivatives—such as …
Article
GMP Challenges for Advanced Therapy Medicinal Products
But even when the first dedicated GMP guidelines for ATMPs are finalized, probably in 2016, they are likely to have to be constantly revised.
Compliance with GMP standards has been a major challeng…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Notably, the latter changes, which will take effect in early 2016, include expectations for authentication of key biological and/or chemical resources, such as cell lines, antibodies, and other biolog…
Article
Quality Systems Key to Lifecycle Drug Management
The aim is to publish a document by June 2016 that builds on other ICH quality guidelines to strengthen quality assurance through harmonized management of post-approval CMC changes.
Agreement and …