The pros and cons of membrane-based WFI generation and distillation for biopharma

Modern ambient water for injection (AWFI) generation system [Image courtesy of CRB]

The pharma industry is in the process of moving toward ambient water for injection (WFI).

Despite changes to regulations almost five years ago that allowed for alternative methods of generating WFI, the industry has been slow to fully embrace the shift away from traditional distillation despite the significant advantages of membrane-based WFI generation.

For companies with legacy distillation systems, the investment in new equipment for ambient WFI can be significant. Given its history, many pharmaceutical companies are familiar with the traditional distillation method.

In this article, industry experts from CRB, Chris Carlson and Jarrod Wrampe, describe the considerations to keep in mind when choosing between membrane-based WFI and traditional distillation for pharma applications.

Pro for membrane-based WFI …
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Drug shortage Alert: Millions of patients affected as FDA reports shortfalls of essential drugs

[Image courtesy of Monkey Business/Adobe Stock]

Millions of U.S. patients are facing medication shortages, according to recent FDA data. The Adderall drug shortage in particular has received significant attention in recent months. Other notable drugs currently facing shortages include the bronchodilator Albuterol and the popular antibiotics amoxicillin and azithromycin.

The pandemic and supply chain challenges are partly to blame for the drug shortages. In recent years, manufacturing output for some drugs sank as a result of factors such as pandemic-induced restrictions and worker shortages. The pandemic also contributed to supply chain disruptions. For instance, China and India, both major suppliers of active pharmaceutical ingredients and other materials. As a result, the pharma industry has been forced to find new ways to ensure a steady supply of raw materials and ingredients.

To illustrate the imp…

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Pharma sector’s reputation dips in 2022 report

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The pharmaceutical industry’s reputation has slid over the past year, according to recent research from reputation data specialist RepTrak (Boston). This year, the sector had a reputation score of 71.3, placing it below the tobacco and transportation sectors but ahead of the retail and consumer services industries.

“With opinions conflicting on the COVID-19 vaccine, and the government’s role in mandating it, this YoY decrease shows that history-changing vaccines were not enough to distract from Pharma’s original sins,” the 2022 Global RepTrak 100 report explained.

Last year, however, the pharma industry had the most significant year-over-year reputational improvement of any sector, according to RepTrak’s 2021 reputational ranking.

The Harris Poll found a similar trend in February, when it found that 47% of people had a positive view o…

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Assessing pharma headwinds and tailwinds in mid-2021

Pfizer-BioNTech COVID-19 vaccine. Image courtesy of Wikimedia Commons.

Now that we have passed the year’s midway mark, pharma continues to be in a unique position.

While COVID-19 gave the industry an opportunity for a reputational reset in 2020, the pandemic is now a net positive for the industry, according to the recent Moody’s report, “Solid demand, lift from COVID-19 products continue to drive positive outlook.”

While demand for COVID-19 vaccines has ebbed recently in the U.S., Moody’s projects strong vaccine sales overall for the remainder of 2021. Pfizer (NYSE:PFE) upped their guidance for vaccine sales to $26 billion in their first-quarter earnings report. “Their approach to guidance for revenue is based on contracts that have been signed,” said Michael Levesque, lead author of the report. Thus, any future contracts that Pfizer signs after that guidance update will further expand their guidance …

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The top 5 pharma firms by reputation

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Recent research from reputation data specialist RepTrak (Boston) indicates that the pharma industry had the largest year-over-year reputational improvement of any sector, according to its roundup of top 100 corporations. The sector saw significant gains in consumers’ perception of its citizenship and governance. 

Now ranked eighth overall, the pharma industry came in just ahead of the consumer services industry and just behind the automobiles and components sector. 

Get the full story from our sister site, Pharmaceutical Processing World. 

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