Search results for "Science"
Article
Biopharma Seeks Balance
During the past 30 years that BioPharm International covered the biopharma market, the industry continually evolved thanks to advances in biology, genomics, and other sciences. The strategic shift by …
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Despite the widespread availability of the STR standard and its low cost, there is little evidence that authentication is routinely used in the life sciences—particularly among academic researchers (2…
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Challenges and Trends in Biopharma Facility Design
BioPharm International spoke with Daniella Kranjac, head, evaluation and offering, Enterprise Solutions, at Cytiva; Mario Philips, president of Single-Use Technologies at Pall Life Sciences; Par Almhe…
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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…
Article
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…
Article
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…
Article
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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