Search results for " industry"
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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A Look Ahead at BioPharma Manufacturing and Regulation
What does FDA and the industry hope to gain by focusing on these areas?
FDA: FDA is responsible for protecting the consumer through the availability of quality products. These approaches fo…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
IMPLEMENTING QUALITY BY DESIGN
The past decade has witnessed an increasing emphasis—by both industry and regulatory agencies—on implementing Quality by Design (QbD) principles. In 2008, the FDA's Of…
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Boosting biopharma resilience: The need to shift focus and increase collaboration
The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength and opportunities for collaborative growth. By …
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Chromatography for the Diversified Antibody Pipeline
The biopharmaceutical industry is engineering for separation by making the bispecifics a heterogenic one—which is different chains to the pair that you can make a whole construct. If there is electros…
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Current Techniques and Challenges Presented in Scaling Between Bioreactors
Jeanne Linke Northrop: How do you see these challenges changing over the next few years?
Andreas Castan: I foresee that the pressure on the industry will accelerate development timelines—it …
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Evolving demands of process development services
Over the years and in light of various industry trends, the demands for outsourced services have increased and evolved. In this interview, BioPharm International discusses how process development dema…
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Enhancing Resins Addresses Purification Concerns
Deorkar also explains that plasmid DNA (pDNA) and recombinant adeno-associated viruses (rAAvs) are two other classes of biologic molecules that are of high interest for the biopharmaceutical industry …
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Modernizing manufacturing
The need to quickly produce millions of doses of new vaccines and therapies spurred industry adoption of innovative testing and production methods. Biopharma companies …
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
…ic modeling?
Whitelock: I would say lack of established mechanistic modeling expertise in the industry. Of course, we're dealing with quite a modern endeavor. In a sense, mechanistic modeling …