Search results for "flexible" in Articles / App Notes
Article
Applying GMPs in Stages of Development
The earlier the product phase is, the more flexible your requirements. As the product approaches Phase III, the board requirements should mimic commercialization requirements. The concept is the GMPs …
Article
Industry Adoption of Single-Use Systems Remains Low
One of the company’s most important investments was the 2012 acquisition of Xcellerex, a supplier of manufacturing technologies, including FlexFactory for biologics, a centrally automated, flexible bi…
Article
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
QbD Improves Cell-Culture Process Control
…les the biomanufacturer to move from a quality-by-testing approach to a QbD approach, which is more flexible (1). By applying advanced sensor systems combined with mathematical modeling techniques, o…
Article
Connected Polishing and Concentration Under One Automation Method
Chromatography and tangential flow filtration (TFF) steps are traditionally performed as separate unit operations in downstream bioprocessing. This work aims to demonstrate the capability of the UNICO…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…
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Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
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Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…