Industry Insights
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Hosts For Vaccine And Virus Expression: Insect Cell Expression Systems
Choosing the right host is key to creating scalable, robust, and reliable commercial processes. Explore common challenges associated with the insect cell culture/baculovirus expression vector systems platform.
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Insights Into The Competitive Clinical Manufacturing Market
There are perhaps too many options when it comes to choosing the right service provider for clinical manufacturing. Drug innovators weigh in on their selection metrics and preferences as well as reveal why vendors lose bids.
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Practical Considerations in Pharmaceutical Production Scale-Up
10/3/2016
Although some scale-ups are easier than others by virtue of their manufacturing process, scale-up is always a meticulous process of trial and error. For each stage of the scale-up process, the product must be physically and analytically tested against approved physical and analytical specifications and the critical process parameters must be challenged in order to ensure the process can be validated.
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How The Right CDMO Partner Can Accelerate Biologics Development
8/25/2022
The manufacturing lag in developing innovative biological drug therapeutics has created a bottleneck, so the industry needs better streamlining. That's where establishing a strategic partnership with the right CDMO partner can step in to accelerate your development and manufacturing timeline.
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FDA Considers These Risk Factors In Scheduling Drug GMP Inspections
9/27/2018
The globalization of the supply chain has expanded the scope of sites the FDA must routinely inspect from those in the U.S. to facilities worldwide.
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Quality Assessment – Quality Metrics That Truly Matter
11/20/2015
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5 Reasons Your Medtech Market Likely Is Smaller Than You Think
9/19/2018
It’s best to be sure you understand the defensible, fact-based market need for your great idea before investing significantly in an intuitive belief of its potential.
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What Pharma Can Learn From Other Industries
9/16/2015
Despite inspired changes in many industries over the last century, clinical trials today remain structurally unchanged since the 1950s. As we look to overcome rising costs and steep failure rates, we may profit from re-examining some of the ideas behind some industrial evolutions.
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5 Translational Research Challenges On The Path To Patients
10/19/2022
As a translational researcher, you’re paving an uncharted path toward exciting new possibilities in healthcare. Explore five difficulties translational researchers face when developing a new therapy.
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Apple Watch Approval Marks Shift In Device Development And Approvals
10/24/2018
Getting to this point has been a multi-year progression of technological development and regulatory evolution by both the market and government.