USA — The FDA has issued final guidance on the use of continuous manufacturing in drug production, aimed at easing the industry’s transition to these advanced processes.

The guidelines cover regulatory and scientific considerations for both new and pre-existing products, including the conversion of batch manufacturing to continuous manufacturing.

The document also includes examples of continuous manufacturing systems and delves into quality control and process monitoring.

The document discusses the FDA’s issuance of final guidance on the use of continuous manufacturing in drug production, aimed at easing the industry’s transition to these advanced processes.

Continuous manufacturing creates products in a consistent flow, as opposed to batch manufacturing, which involves multiple steps done over a longer period and across different sites.

The FDA’s guidance adds to an overarching advisory framework established through other International Council for Harmonization (ICH) guidelines and is regarded as an attempt to harmonize regulatory considerations surrounding continuous manufacturing.

The adoption of continuous manufacturing has been cited as a solution to address ongoing challenges facing pharmaceutical supply chains, as highlighted by the difficulties during the Covid-19 pandemic.

Continuous manufacturing has the potential to improve access to essential medicines. By using this method, pharmaceutical companies can produce drugs more efficiently and cost-effectively, allowing them to increase their production capacity and potentially lower prices.

This is particularly important for low- and middle-income countries, where access to essential medicines is often limited.

The guidelines also include examples of continuous manufacturing systems used to produce therapeutic proteins and tablet drugs.

Additionally, the FDA shared a discussion paper on the implementation of artificial intelligence in drug production, which seeks feedback from industry stakeholders before the May 1 deadline.

Continuous manufacturing’s potential to mitigate the industry’s environmental impact

The Biden administration called for increased public investment in continuous manufacturing in a June 2021 report, providing funding to boost US-based production of critical medicines and mitigate the industry’s environmental impact.

The impact of climate change on health cannot be ignored, with extreme weather events affecting food security, air pollution from wildfires, and the spread of infectious diseases.

The World Health Organization warns that climate change is the biggest health threat to humanity and could cause an additional 250,000 deaths annually by 2030-2050 from malnutrition, malaria, diarrhea, and heat stress.

Ironically, while the pharmaceutical industry plays a crucial role in promoting health, it is contributing to the climate crisis.

Accounting for 4.4% of global emissions, its CO2 footprint is expected to triple by 2050 if no action is taken.

In 2019, the industry generated 48.55 tonnes of CO2 equivalent for every US$1 million, which is 55% more than the automotive industry’s 31.4 tonnes per US$1 million generated in the same year.

Given the inextricable link between climate and health, the pharmaceutical industry has a unique responsibility to reduce its greenhouse gas emissions and combat the adverse health consequences of climate change.

To do so, companies must prioritize the development of medicines and provide access to those most affected by the climate crisis, who often live in resource-poor settings.

It is crucial for the industry to take proactive measures to address the issue before it escalates further.

One company that is leading the way in reducing carbon emissions in the pharmaceutical industry is GlaxoSmithKline (GSK).

As a leader in respiratory medicine, GSK has recognized the environmental impact of inhalers for asthma and other lung conditions.

While metered dose inhalers (MDIs) containing ozone-depleting chlorofluorocarbons were phased out in the 1990s, today’s devices still contain hydrofluorocarbons, which are potent greenhouse gases.

In response, GSK has been developing a lower-emission propellant with the potential to reduce greenhouse gas emissions from its inhalers by 90%.

Overall, pharmaceutical companies have a unique responsibility to address the interlink between health and climate change, and continuous manufacturing and sustainable practices are key to improving access to essential medicines while reducing the industry’s environmental impact.

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