Industry Insights
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Raise Your Upstream IQ: Process Development Optimization Considerations
7/20/2020
How can you intensify your cell culture processes, in order to keep pace with today’s industry and regulatory expectations?
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Choosing The Right Primary Container And Troubleshooting Issues
8/25/2023
Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.
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The Future Of Automation For Container Closure Integrity Testing
10/19/2023
New regulatory guidance documents continue to tighten the narrative on what is expected of container closure integrity.
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An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market
2/21/2018
Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.
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Potential Pitfalls of Outsourcing
2/9/2000
Although outsourcing to a contract manufacturer is a rapidly growing trend in the pharmaceutical industry, it is still a relatively new concept for many companies...
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The 5 Basic Tenets Of Data Integrity — And How Failures Occur
7/14/2016
With all the data integrity issues highlighted in regulatory agency inspections over the last several years, it seems very few people are familiar with the court case that set the legal precedent for data integrity standards. This is largely the reason why we see so many data integrity issues today.
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Leveraging Filtration Plates To Accelerate The Detection Of Vitamin B6 In Clinical Samples For Research Purposes
6/9/2022
By employing a simple strategy many different lab protocols where filtration is required can be accelerated. Learn more about automation-friendly 96-well filter plates that enable more samples to be filtered in one go.
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Single-Arm Trials Use Real-World Evidence For Rare Disease Drug Development
3/1/2022
In rare disease product development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Gain insight into the regulatory considerations for single-arm trials.
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Avoiding Project Risks When Building ATMP Facilities
8/16/2022
What are five factors that can mark the difference between success and failure of your ATMP project?
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Data Integrity In Supply Chain Risk Management During Zero Trust
6/21/2021
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.