Search results for "Blood" in Articles / App Notes
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Challenges in Analytical Method Development and Validation
For example, for blood or blood plasma products, validation of potency and some safety test methods is expected much earlier (clinical Phase 1). For most other products, method validation is typically…
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Join the Plasma Product Biotechnology Meeting
We are pleased to announce the 12th International Plasma Product Biotechnology Meeting to be held in Limassol, Cyprus, 31 October - 3 November, 2022.
The Plasma Product Biotechnology Con…
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Science Focus Fuels Successful Process Development for Startups
In addition, development work at Celyad is usually performed with healthy donor materials such as blood and bone marrow taken via apheresis; clinical manufacturing deals with starting materials collec…
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Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.
By Cynthia A. Challener
MG/Stock.Adobe.com
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Ensuring Viral Safety of Viral Vaccines and Vectors
In the past, a few medicines produced from biological materials, such as blood products or vaccines, were found to be contaminated with viruses. Unscreened human or animal-derived products, such as bo…
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A Look into the Future of Biopharmaceutical Quality
Some of these are autologous products using a patient’s own blood components and personalized medicines can present additional manufacturing, compliance, and regulatory challenges.
Quality Control…
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Understanding Validation and Technical Transfer, Part 3
In this example, the patient’s blood is passed through a device where cells are separated and segregated, and the remainder is returned to the patient. The cells of interest are isolated from the aphe…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
In Japan, three companies are fractionating plasma: the Japan Blood Products Organization, the Chemo-Sero Therapeutic Research Institute (Kaketsuken), and Takeda, which recently acquired the Shire pla…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
But the experts sought assurance of security, accuracy, and reliability for Novartis’ complex system for removing blood T-cells from the patient, cryopreserving them for transport to a company proces…
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Patenting Prospects for Cell-Based Therapies
The history of biomedical advances over the past 50 years has focused predominantly of increasing complexity, from small-molecule therapeutics to antibodies, cytokines, blood-clotting factors, and pro…