Search results for "Science" in Articles / App Notes
Article
A Look into the Future of Biopharmaceutical Quality
BioPharm: Do you foresee science outpacing quality regulations?
Schniepp (RCA): I think science has already outpaced quality regulations. An example is the applicability of pharmacopeial method…
Article
Securing the Single-Use Supply Chain
…m a supplier, according to John Briggs, director of quality, regulatory, and compliance at ASI-Life Sciences. As a result, adds Mario Philips, vice-president of single-use technologies at Pall Life S…
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Maximum Output Starts with Optimized Upstream Processing
As a result, a strong and sustainable supply network is more vital to ensure supply chain stability, according to Youngsun Kim, director of the manufacturing science and technology team at Samsung Bio…
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Improving Upstream Predictability
… process control, says Avril Vermunt, strategic technologies partnerships leader at Cytiva’s life-sciences division. “PAT has matured and is used more routinely now, through in-line pH, dissolved oxy…
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The New World of Biopharmaceutical Manufacturing
…Technical Operations at Merck; Helene Pora, PhD, vice-president, Single-Use Technologies, Pall Life Sciences; Peter Levison, senior marketing director, Downstream Processing, Pall Life Sciences; Frit…
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Regulatory Challenges in the QbD Paradigm
Regulators also must offer more flexibility regarding manufacturing changes and application supplements based on science and risk assessment, so that limited resources on both the industry and regulat…
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Cell-free Expression Systems Pose Cell Culture Alternative
About the author
Feliza Mirasol is the science editor for BioPharm International.
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Remote Monitoring and Big Data Advance Upstream Automation
Throughout the pharma industry, not just in upstream bioprocessing, there is, adds Dorizon Navarro, life sciences industry consultant at Rockwell Automation, an explosion of the integration of multipl…
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Emerging Therapies Test Existing Bioanalytical Methods
About the authors
Christina Satterwhite, PhD, is senior director, global laboratory sciences; Jessica St. Charles is director, laboratory sciences; Valerie Theobald is director, immunoanalytical s…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Michalle Adkins, director of life sciences consulting at Emerson Process Management, discussed the group’s progress at INTERPHEX on April 2, 2019 (3).
As she noted, biopharmaceutical manufacturers…