Search results for " manufacturing"
Article
Biopharma Manufacturers Respond to Ebola Crisis
FDA also is working with WHO’s International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate testing of experimental treatments and to provide more flexibility for meeting manufact…
Article
Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
“With this partnership, Akron demonstrates its continued commitment to supporting the advancement of cell and gene therapies with cGMP [current good manufacturing practice]-compliant solutions at indu…
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Fusion Proteins Pose Manufacturability Challenges
Combining two different proteins in one molecule can lead to instability, which creates manufacturing challenges during both upstream and downstream processing. Solutions for overcoming these issues a…
Article
Vaccine Development and Production Challenges Manufacturers
A Merck scientist similarly explained at WCBP how a matrix approach to demonstrating process and product comparability was leveraged to evaluate manufacturing changes. That was key to demonstrating th…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Today we are going to discuss what is your media and how costly variability of the cell culture media is to the manufacturing process. I am Megan Manzano, senior editor for BioPharm Interantional. Joi…
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Cytiva Opens Biotechnology Manufacturing Center in UK
In the first half of 2019, the center will start producing a fiber-based chromatography purification platform, which has the potential to improve efficiency in the purification steps of manufacturing …
Article
Implementing QbD in Sterile Manufacturing
Critical quality attributes
BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing?
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Article
Pulling Out All the Stops in mAb Manufacturing
The need for good manufacturing practice compliance for mAbs going forward is increasingly crucial.
Learn more here
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Manufacturing of Vaccines and Viral Vectors
However, the challenge not only lies in developing a vaccine but also in the ability to scale up the manufacturing process.
In this article, general guidelines for scaling up a viral vector and vi…
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
A streamlined control strategy for AstraZeneca’s development of ICB to test this implementation for 14 days of continuous end-to-end process operation at the clinical manufacturing scale will be prese…