Search results for " industry"
Article
An Analytical Approach to Biosimilar Drug Development
…arge-molecule characterization and analysis with the growth of biotherapeutics in the pharmaceutical industry pipleline (2).
As a result, demand has increased for chromatography and mas…
Article
Modeling the Degradation of mAb Therapeutics
Buffer exchange was used to monitor the aggregation kinetics of this mAb under the conditions that are prevalent in the biopharmaceutical industry during downstream purification.
Detailed expe…
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Preparing for the Future: Visions and Insights for Biomanufacturing
In the e-book, six industry experts share their bioprocess visions and advise on digital automation, innovative process approaches, and more.
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Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Something that the industry should strive for implementing,” Laird includes.
Future process trends
Anticipated future trends in cell-culture process evolution include the trend toward miniatur…
Article
Making the Move to Continuous Chromatography
In the case of antibodies, the industry is now working well above 3 g/L, even up to 5 g/L, with titers of 10 g/L being described. “To really maximize productivity, the kinetic effects of adsorption:de…
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Modern Manufacturing Key to More Effective Vaccines
He noted that continuous manufacturing platforms can help ramp up vaccine supply on short notice and that FDA clarification of its requirements and standards should encourage industry investment in ne…
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Impurity Testing of Biologic Drug Products
In this roundtable discussion, industry experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
Method development and validation
B…
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3rd BioProcessing Asia Preview: Q&A with John Curling
We founded BioProcessing Asia to enable scientists from academia and industry, and from the East and West, to meet in an environment where the most recent achievements, breakthroughs, and technologica…
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Process Development: What May Lie Ahead in 2018?
Safety and Regulatory Concerns
As scientific breakthroughs continue to advance the biopharmaceutical industry, safety issues (new and old) must also remain a top-of-mind concern for the biopharmac…
Article
Transformative Medicines Challenge FDA and Manufacturers
FDA, Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products, Final Guidance (CDER, January 2017).
2. FDA, Human Factors Studies and Relat…