Insights On Regulatory Compliance
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The Ongoing Pursuit Of Manufacturing Digitalization
11/1/2022
Explore Pharm 4.0, how this methodology can help with the growing demand for Oligo drug substance, and the benefits made possible by its digitalization plan.
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Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles
8/8/2023
As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.
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What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product
8/11/2023
Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.
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Apheresis Variability Control In Cell Therapy Manufacturing
7/25/2022
Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.
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Match Your Development And Manufacturing Path To Your IND Milestones
2/17/2023
The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.
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3 Ways To Improve QMS Documentation: Following International Standards
9/8/2022
We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.
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Don't Skip Preformulation: Your Blueprint For Drug Development Success
9/22/2023
Investing in the right preformulation studies and gathering evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight.
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Sterile Filtration And Quality Risk Management
8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Do You Have an FDA Audit Process in Place?
2/23/2023
Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.
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Is Your QMS 21 CFR Part 11 Compliant?
12/5/2022
With many options for digital transformation in the quality software sector, there’s never been more opportunity to digitize your QMS. Explore the benefits of a digital QMS and more.