Search results for "Science"
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
By Feliza Mirasol
science photo\Shutterstock.com
Cell-culture processes for Phase III biologic drug development and commercial manufacturing present challenges, suc…
Resource
PREP Symposium
PREP 2019 is the longest running, most recognized international scientific conference and exposition driving the field of Preparative and Process Chromatography, organized by expert scientists and eng…
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Understanding Validation and Technical Transfer, Part 3
In terms of quality by design (QbD), specifications account for only one element of the overall product control strategy, which should employ a science and risk-based approach to define quality attrib…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
In India, Reliance Life Sciences manufactures a range of plasma products for the subcontinent and Sri Lanka. Meanwhile, Intas and Hemarus have smaller fractionation capacities. In Korea, three compani…
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Making the Move to Continuous Chromatography
…ity attributes of a particular purification step have not evolved at the same rate as their process science counterparts,” Sulzberger says. Since PAT is not yet a viable reliable option, he notes tha…
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Modern Manufacturing Key to More Effective Vaccines
Krause emphasized how FDA strives to review and approve submissions and manufacturing supplements in a “sensible” way that emphasizes good science. CBER also encourages manufacturers to meet with FDA …
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Industry Adoption of Single-Use Systems Remains Low
…,” adds Parrish Galliher, chief technology officer of Upstream BioProcess at Cytiva’s Life Sciences division.
Cost and time savings
To date, has single-use manufacturing technology th…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
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FDA Framework Spurs Advanced Therapies
FDA Commissioner Scott Gottlieb recognizes that cell-based therapies are “one of the most promising fields of science.” At the same time, the “area’s rapid growth, dynamism, and complexity” are creati…
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3rd BioProcessing Asia Preview: Q&A with John Curling
What is the basic concept for the BioProcessing Asia (BPA) conference series?
Until 2014, when we held the first BPA conference, Asia lacked a forum for a science and technology-focused discussi…