Insights On Regulatory Compliance
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Trends In Next-Generation Delivery Technologies
11/22/2023
Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.
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Validated LC–MS/MS Method For The Determination Of Copanlisib
11/14/2022
Review study findings on a validated LC–MS/MS method for quantifying copanlisib from a mouse dried blood spot and its potential for enabling desirable sensitivity, accuracy, and precision.
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Annex 21 – Are We On Track And Is There An Impact?
5/6/2024
What does Annex 21 entail, what makes the process of meeting the requirements so complex and time-consuming, and has Annex 21 inadvertently created additional barriers to supply.
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Cutting-Edge Automation Revolutionizing Cell Line Development
8/1/2023
Advancements in cell line development workflows have created the potential for greater standardization and automation, eliminating the most common workflow bottlenecks and improving reproducibility.
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Transitioning To Pharmaceutical Validation 4.0
5/16/2023
To help companies achieve Pharma 4.0, the International Society for Pharmaceutical Engineering is driving Validation 4.0 as a way to help organizations expedite the computer software validation process.
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The Importance Of 503B Facilities In Drug Manufacturing Today
10/5/2023
Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.
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Embracing And Implementing Computer Software Assurance Guidance
5/18/2023
Pharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.
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Regulatory Submission Crisis Rescue: When To Take Action
6/12/2023
While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these can be avoided in this article.
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Implementing A Risk-Based Approach To Calibration
2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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Developing Injectable Drug Placebo Formulations For Clinical Trials
1/9/2024
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.