Search results for "regulatory" in Articles / App Notes
Article
Principles of Cell Line Development
It also takes a closer look at where it fits into this wider process including:
Overall path to market
Key processes and methods
Tools and equipment
Key regulatory re…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Meanwhile, new analytical, quality assurance, and regulatory approaches are needed to implement lot testing and control of DNA and cell-free extract quality, such that product quality is ensured but l…
Article
Novavax Reports on Two Vaccine Efficacy Studies
Novavax said that it intends to file for regulatory authorizations in the third quarter of 2021 and, if approved, is scheduled to manufacture 100 million doses per month by the end of the third quarte…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
…s experience with using Protein A-like resins, their performance and track-record, as well as their regulatory acceptance and the industry’s familiarity with the equipment needed to use them, says Sc…
Article
Basics in Process Development for Biotherapeutics
Click here to learn more >>
Definitions, activities, and things to consider when developing an upstream or downstream bioprocess.
Article
EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The paper will address options for introducing a new strain into an existing approved vaccine; the minimal regulatory requirements for quality, safety, and efficacy; and bridging studies required to p…
Article
Virus-like Particles as Therapeutic Moieties of the Future
A VLP-based vaccine for malaria, Mosquirix (RTS/S), has received approval from regulatory authorities. This is the first vaccine for malaria in the world (9).
Attempts have been taken to widen …
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“The expertise to run a plant is not in the systems or equipment, but in the team and its experience, including quality, regulatory, and technical experience,” he asserts.
COVID-19 and changeover …
Article
Considerations for Optimizing Process Development
Click here to read the article >>
Intensify your cell culture processes to keep pace with today’s industry and regulatory expectations.
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Perfusion adds considerable mechanical complexity and regulatory uncertainties (i.e., it is avoided for GMP manufacturing, expert staff are needed, etc.), as well has having limited equipment options …