Search results for "continuous processing"
Poster
Continuous chromatography in downstream processing of a monoclonal antibody
In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monclonal antibody (MAb) purification proces…
Article
Developing a Continuous Large-Scale Prefusion Cell Culture Process
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Perfusion processes enable continuous operation over extended periods of time by constantly providing fresh nutrients for the cells and simultaneously removing …
Poster
Scalable Continuous Chromatography Process for Enhanced Efficiency in Biomanufacturing
The cost pressure on biopharmaceuticals drives the industry toward exploring process intensification options that will maintain or improve quality, stability, and manufacturability of the product wh…
Article
A Continuous Confidence Boost
Continuous processing of monoclonal antibodies (mAb) could offer a number of advantages, but regulatory uncertainty and upfront investment remain sticking points.
In this case study, Shanghai Henli…
Article
Life Science Online Training: Build Your Skills and Continue Your Education
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Cytiva continuously adds courses to cover a spectrum of life science topics such as chromatography and bioprocessing. You can find valuable course content for researc…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…