APR January/February 2022 - 8

CNPerspectives
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Pharmaceutical Outsourcing, Biocompare, Labcompare, and Tablets & Capsules.
Managing Risk in API Manufacturing is the Key to Successful
Projects, Safer Drugs
Because of the nature of the business, every drug manufacturer faces the risk of unexpected events that can cause harm to consumers and
cost the company money, resources and its reputation. Yet, in chemistry, there's a lot of uncertainty - in how a molecule will react, how an
API will perform when scaled up, including its overall impurity profile, how smoothly it passes clinical trials and when a drug product will be
cleared for FDA approval. And these types of risks, attributed to the unknown nature of molecular structure, are compounded by increasing
R&D costs, looming patent expiration dates, growing competition and increasing regulatory requirements. In fact, it takes an average of 12
years for an experimental drug to become commercialized in the U.S.; and only one in 5,000 drugs make it that far.
https://bit.ly/3ANQ3g9
Recreating Cell Niches in 3D Cultures
Three-dimensional (3D) cell culture adds biological relevance to a wide range of assays for testing pharmaceuticals, food, and personal care
products, but creation of lifelike assay systems is only achievable if cells are grown in environments similar to their natural niches. Achieving
this level of similarity begins, of course, with the cells themselves, which is why heart models employ cardiomyocytes and nerve models
start with neurons (or, in both cases, progenitor cells capable of differentiating into those target cells). Once developers settle on suitable
cell types the problem reduces, as some might say, to " mere engineering, " but those details are what make 3D cell culture interesting, and
challenging. The remaining factors to control, in the quest to industrialize production and use of organoids, spheroids, and other advanced
cell-based models, include the culture medium, cultureware, and matrix.
https://bit.ly/3ri6n5z
Tackling Cold Storage Challenges to Ensure Vaccine Equality
With the COVID-19 Omicron variant spreading rapidly across the world, logistics challenges continue to be a barrier to global vaccination,
from first-mile to last-mile distribution. While developed nations like the United Arab Emirates and Portugal are well under way of vaccinating
their entire populations, transportation and infrastructure challenges in less developed regions continue standing in the way of vaccination
rate improvements. In fact, nearly 60% of people in advanced economies are fully vaccinated, while a staggering 96% of people in low-income
countries remain completely unvaccinated. As vaccination barriers in these regions persist, COVID-19 will only continue to spread, giving way
to additional mutations. Fortunately, vaccine inequity can be solved through the implementation of flexible cold storage infrastructure in
remote regions.
https://bit.ly/3gf3j48
The Expanding Role of Effervescent Technology
From beverages to laundry detergent, consumer packaged goods (CPGs) traditionally sold as liquids, are increasingly being offered in
effervescent tablet and powder forms. Consumers have embraced these products as convenient, portable, and more environmentally friendly
than their liquid counterparts. The trend has captured the attention of large and small CPG manufacturers. Start-ups dedicated to the concept
have emerged, and established brands have expanded product lines to include tablet forms of familiar household essentials. While these
products span a wide range of shapes, sizes, and categories, they all leverage the benefits of effervescent technology.
https://bit.ly/3GkRLXk
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| January/February 2022

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APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022