Search results for "manufacturing" in Articles / App Notes
Article
Continuous Chromatography: Trends, Definitions and Approaches
The process parameter, both key and critical, will have their ranges validated so even during manufacturing of a single batch, changes in these parameters will be allowed as long as the product’s CQAs…
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USP Publishes Monoclonal Antibody Guidelines
Besides serving a much reduced patient population because of their specific applications, biologics manufacturing requires living material and a much more complicated process than small-molecule synth…
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Labeling of Biosimilars
… on the quality characteristics—pharmacochemical and biological properties—as determined by the manufacturing process. Under the EU’s step-wise approach to biosimilars, these characteristics and any …
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Quality by Design and Extractable and Leachable Testing
The relationship between the materials selected, the manufacturing process, and critical quality attributes are described in the design space. This defined relationship will provide assurance of quali…
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Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
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Gowning Practices Provide Clues to cGMP Compliance
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMPs). Quality must be built into the design of a facility to ensure that drugs are manuf…
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Q&As with Industry Leaders
…nbsp;Cytiva
What's in Your Media? How Costly is Variability of Cell Culture Media to Your Manufacturing Process?
Megan Manzano, BioPharm International
Christopher Woolstenhulm…
Article
EMA Collaborates with HTA Assessment Networks
“This is not necessarily linked to the development of new manufacturing processes per se, but more to the need of identifying a common set of data requirements,” he added.
EUnetHTA has been step…
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Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
…
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Under pressure: exploring root causes of leaks in single-use mixers
It reduces downtime by eliminating cleaning steps, helps avoid risk of cross-contamination, and enables modularity in manufacturing and unit operations.
But efficiency isn’t just about what your e…