Search results for " characterization" in Articles / App Notes
Article
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…
Article
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…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Stückler not only showed how the approach could be used for deeper process understanding in early process development, but also the benefits of mechanistic models at the process characterization, vali…
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From Darwin to Recombinant Fc Multimers
The session covered both new plasma products as well as products and technologies for plasma processing or characterization. Fabian Käsermann from CSL Behring Switzerland talked further about the Fc m…
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Lessons Learned Accelerate Vaccine Development
That deep understanding will be developed through the application of advanced analytical tools for characterization. “Quality by design, high-throughput screening, high-throughput sequencing, small-sc…
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Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
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Breakthrough Drugs Raise Development and Production Challenges
A key decision for manufacturers is whether to devote more resources to the project early to front-load process characterization and validation activities, even before gaining the breakthrough designa…