Ensuring Integrity of Drug Formulation from Development to QC

pharmtech

After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy.
 This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.
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Spotlight

When it comes to safely and securely transporting high value pharmaceutical products, the stakes couldn’t be higher. Not only is a single consignment of high value drugs potentially worth upwards of $50 million, but, for those patients in need of these drugs, ensuring these products arrive on time and in optimal condition is quite literally a matter of life and death.


OTHER ON-DEMAND WEBINARS

Embase for biomedical searching: Indexing and retrieval

Elsevier

How we index a typical article What is our approach to indexing and how this has evolved over time How drugs, diseases and devices are indexed in Embase. How indexing in Embase helps you find the information you’re searching for.
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Decoding Drug Resistance with Machine Learning and Systems Biology

Cytobank

Learn how a systems biology approach that utilizes machine learning tools facilitates drug resistance discovery. Special guest, Cancer Biology PhD candidate Reema Baskar, co-mentored by Drs. Sean Bendall and Sylvia Plevritis of Stanford University, will show you how they leveraged Cytobank along with other computational tools to identify mechanisms of drug resistance in cancer cells.
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Automating Biopharma Quality Control to Reduce Costs and Improve Compliance

LabRoots

One report suggests that an average pharmaceutical manufacturing plant spends around €40M per year on quality control1. At the same time another report states that 79% of all 483 Warning Letters issued by the FDA in 2016 cited 21CFR part 11 data integrity issues. Whilst re-training is a common response to an FDA 483 Warning Letter, this may be only part of the solution: was the problem simply that the worker(s) didn’t understand the SOP correctly, or was it really that the SOP is not robust enough to prevent future recurrences of the problem?
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Pharmaceutical Impurities

thermofisher

Hear how you can optimize your impurity analysis workflows to obtain greater productivity, sensitivity, accuracy and reproducibility to meet increasing regulatory requirements and lower limits of detection. Learn how to achieve all of this, whilst also increasing laboratory efficiency and reducing the cost per sample.
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Spotlight

When it comes to safely and securely transporting high value pharmaceutical products, the stakes couldn’t be higher. Not only is a single consignment of high value drugs potentially worth upwards of $50 million, but, for those patients in need of these drugs, ensuring these products arrive on time and in optimal condition is quite literally a matter of life and death.

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