Search results for " design" in Articles / App Notes
Article
Can Vaccine Development Be Safely Accelerated?
The Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), collaborated with Moderna to design the vaccine…
Article
2019’s Top Bioprocessing Trends and What to Expect in 2020
FDA approvals announced during the year for cell and gene therapies prompted the need to consider manufacturing facility designs specific to cell and gene therapy workflows, as well as the need to exp…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Advanced therapies may be eligible for one or more of these designated pathways if they treat a serious condition, address unmet medical needs, or obtain early clinical results that show significantly…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
This has two immediate consequences:
Patenting strategies for products will become more complex in order to address the number and type of patient groups for which a product is designed.
…
Article
Best Practices for Selecting a Top-Quality Cell Line
“Additionally, Cai notes that bioinformatics methods can help rationally design a host cell through determination of ideal genome sites for target integration and pathway engineering based on RNA seq…
Article
Automating the Biomanufacturing Process
Besides data storage, analytics, and generation of process data, especially in single use (SU) processing, sensor incorporation in the biobag design is important. This allows for direct measurements w…
Article
Using Multiple Techniques in Biosimilar Analysis
It also illustrates that exploring orthogonal techniques, and indeed, letting them ‘compete’ with one another, can enhance experimental design, especially for products challenging the resilience of a …
Article
A Plastic Pipeline for Commercial Bioprocessing?
Olivier Loeillot, general manager, global product bioprocess, Cytiva—which supplies both single-use and traditional stainless-steel equipment—says up to 70% of new plants are being designed to use sin…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
CBER had granted the RMAT designation to 24 products as of June 30, 2018, and more new products seek to qualify for that treatment.
CBER also is working with the National Institute of Standards…
Article
Understanding Validation and Technical Transfer, Part 2
It is convenient to break down equipment qualification into several steps such as design, installation, and operational as described below for the coffee brewing example.
Tasting studies may ha…