APR Sept/Oct 2023 - 8

CNPerspectives
American Pharmaceutical Review is one of several outstanding publications available from CompareNetworks, Inc.
Here is a look at the insightful content our readers may enjoy from four of our sister resources:
Pharmaceutical Outsourcing, Biocompare, Labcompare, and Tablets & Capsules.
A Review of How Real-World Evidence Enhances Regulatory
Submissions
The importance of using real world evidence (RWE) for efficacy has gained significant momentum over the past few years as regulators are
increasingly calling for the use of real-world data (RWD) and RWE. Regulatory bodies across the world, including the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA), have released guidance to clarify their expectations for the use of RWD and
RWE for regulatory decision-making.
http://bit.ly/3ryHOo2
Upstream Manufacturing for Cell and Cell-Based Gene Therapies
Cell and cell-based therapies have seen explosive growth since 2017 when Kymriah, the first receptor-T cell (CAR-T) therapy, was approved
for use in the United States as a treatment for lymphoma. Today, CAR-T is regarded as mainstream within the emerging advanced therapy
industry, with up to 12 new cell (and gene) therapies expected to be approved in the U.S. in 2023 alone.
However, despite its early successes, cell therapies like CAR-T still face limitations and challenges, sometimes due to the quality of the starting
cells or difficulties during processing. In this article, we discuss what to consider during upstream manufacturing of cell and cell-based
therapies, including during cell harvesting, preservation, and growth.
https://bit.ly/3rADu7J
Micromachined HPLC Columns Can Revolutionize
Proteomics Workflows
Technology has advanced tremendously in recent years and is still evolving to help scientists discover new information quicker and more
efficiently. For researchers who study proteomics, which can be notoriously time consuming and complex, workflows that provide faster
throughput, higher sensitivity and deeper coverage, even at single cell level, allow scientists to gather more valuable information each
time a sample is processed. But more importantly, reproducibility ensures that the discoveries are meaningful. Micromachined high
performance liquid chromatography (HPLC) columns, also referred to as micro pillar array columns (µPAC) enable scientists to consistently
replicate sample runs in their labs.
https://bit.ly/3ZI88sA
Lessons Learned: How Can the 'Nitrosamine Crisis' Inform
Future Formulations?
Nitrosamines are not an intentional part of a medicine's chemical composition, but can form from reactions between some active pharmaceutical
ingredients (APIs) and components of excipients. An increasing awareness of this phenomenon reached a fever pitch over the past few years.
This 'nitrosamine crisis', which led to recalls and the complete withdrawal of one 'over the counter' active ingredient, should be a wake-up call
for our industry. It can provide useful lessons, and perhaps prevent another such crisis in the future.
https://bit.ly/3ZyTvHZ
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| September/October 2023

http://bit.ly/3ryHOo2 https://bit.ly/3rADu7J https://bit.ly/3ZI88sA https://bit.ly/3ZyTvHZ

APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023