Search results for " characterization"
Article
Monitoring and Control of Inline Dilution Processes
Another important factor for consideration, according to Vermunt, is the fact that for many buffers, creating a concentrate suitable for ILD is equal to the study and characterization needed for use-s…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
What’s more, analytical platforms for in-process control and cell characterization are lacking in the cell therapy industry but are being actively pursued.”
It is important to note, however, whe…
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Moving PAT from Concept to Reality
Raw-material characterization is performed using handheld Raman/near infrared (NIR) scanners. In bioreactors, in-line sensors measure pH, temperature, dissolved oxygen (DO), and carbon dioxide; in-lin…
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Emerging Therapies Test Existing Bioanalytical Methods
The time upfront in production and characterization of high-quality reagents will result in reduced cost and timelines for the program. Experiments to develop the methods should be carefully thought t…
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Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…
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Scaling Up Novel Therapies
They also allow manufacturers to leverage performance data across multiple products, reducing the cost of late-stage process characterization and qualification. In addition, they permit some degree of…
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Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
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Modern Manufacturing Key to More Effective Vaccines
…ther regulatory authorities and WHO to gain convergence on key issues, such as exceptions to product characterization and testing procedures, and where certain aspects of process validation could be …
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Transformative Medicines Challenge FDA and Manufacturers
Safety issues derailed advances in this area some 20 years ago, but now better understanding of oligo chemistry and product characterization are driving research programs. FDA set the pace in approvin…
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Development of Purification for Challenging Fc-Fusion Proteins
In the absence of detailed characterization of the LMW impurities, different cation and mixed-mode chromatographic resins were screened during the initial phase of development.
It was qui…