Search results for " start"
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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…
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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 …
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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…
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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,…
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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…
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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…
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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 …
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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…
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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…
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Being Thorough When Transferring Technology
Other examples are unexpected low titer compared to process development runs or unexpected filter clogging in depth-filtration steps due to different quality of filtration starting material. An exampl…