Search results for " preclinical development; clinical …"
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
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Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
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From Darwin to Recombinant Fc Multimers
Topics from a Darwinistic viewpoint on how business models are evolving in the Life Science industry to breakthrough research data from Momenta Pharmaceuticals on a recombinant trivalent Fc protein …
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CDMOs Driving Emerging Bio/Pharma Success
CDMOs Driving Emerging Bio/Pharma Success
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
By Jim Miller
Emerging bio/pharmaceutical companie…
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The Smart Benefit of Digital Systems in Preclinical Studies
The advancement of smart drug development reaches far back in the drug development cycle, starting at the R&D phase and moving through the pipeline through to clinical studies. Data gathering…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
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Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
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Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
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Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…