Search results for " start" in Articles / App Notes
Article
Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…
Article
Start With the End in Mind: GMP Tech Transfer
How can you be one step ahead in process development and prepare for future GMP work?
Hear what tech transfer experts have to say about this important issue in this blog. And, learn how to apply …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Instead, to comprehensively follow QbD principles, the process should start with a statement of method design intent incorporating method performance characteristics focused on the minimum quality sta…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Oftentimes with a lot of startup companies, I've seen a lot of stumbling blocks as they get to the R&D process and they're starting to inch forward into commercialization. When they get to that phase,…
Article
Mapping a Route for Cell and Gene Therapy Process Development
Scale up and mass production of the final product starting from a small seed bank (for instance, a master cell bank or working cell bank established from a healthy donor) is the main focus of the allo…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Particularly for Fc-fusion proteins, these improvements have resulted in a new set of starting conditions for downstream processing, including elevated levels of high molecular weight species (HMWs; u…
Article
Moving PAT from Concept to Reality
Although many large multinational manufacturers have adopted and implemented various forms of PAT, many companies are still struggling to get started, according to Joe Makowiecki, enterprise solution …
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
“For a 50-L bioreactor run, the intermediate downstream processing volumes can already be below 2 L after the capture steps, but single-use mixers currently on the market start at 50 L,” she explains.…
Article
Report from the 6th International HTPD Conference
The HTPD conference series started as a joint initiative by Cytiva and Genentech in 2010 at a time when high-throughput process development was in its early days. HTPD was mainly limited to 96-well pl…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
This situation has started to change with FDA granting Emergency Use Authorizations to the mRNA vaccines from Pfizer-BioNTech and Moderna for COVID-19 in late 2020 and approval for the viral-vector va…