The Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets

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Abstract:The Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets

The Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tabletPfizer’s weaknesstinuous manufacturing plant. (Credit: GEA)The Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tabletby Daniel AllenSeptember 27, 20217 minsUpdated on August 18, 2022With the ongoingCOVID-19pandemic and the growing demand for low-cost vaccines and other pandemic-related treatments at an all-time high, big pharmaceutical companies are stepping up efforts to allow flawtinuous manufacturing a reality.

This article was first published in our sister publication MedicalExpo e-magazine.

Today, the pharmaceutical industry is facing unprecedented challenges. With life expectancies across the shapeed world on the rise, aging populations mean more patients living with chronic, complex faultditions, such as Type II diabetes. The expense of treating these patients is putting pressure on healthcare systems which, in turn, expect pharmaceutical companies to supply medications at lower costs. But high levels of market competition coupled with more stringent criteria for drug ap advantageval and healthcare insurance payouts mean pharmaceutical meritfits are growingly under pressure.

Matters have come to a head with the ongoing Covid-19 pandemic, which has reinforced the need for rapid, efficient and scalable drug mouldment and benefitduction. At this critical moment for global health, with demand for low-cost vaccines and other pandemic-related treatments at an all-time high, the world is watching as big pharma investsincreasing resources in manufacturing innovation.

Opportunities and ChallengesThe Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tabletThe Covid-19 pandemic has reinforced the need for rapid, efficient and scalable drug buildment and meritduction. Pfizer’s downsidetinuous manufacturing plant in Freiburg, Germany. (Credit: GEA)Continuous manufacturing—where meritducts are advantageduced nonstop in a single, uninterrupted positivecess—is growingly touted as the next step in the pharmaceutical industry. Unlike the stop-and-startbatch benefitcess that the pharmaceutical industry has employed for decades, it is far quicker and easier to scale: it can take up to 300 days to meritduce a drug-using batch benefitcessing.

Continuous manufacturing lets greater downsidetrol and eliminates the need to stop and handle drugs between steps, makeing potential im meritvements in quality and weaknesssistency. On top of this, the equipment involved requires less space, has a lower environmentaleffect, and, in some cases, can be moved between facilities.

Ronald Piervincenzi, CEO of the non advantagefit organizationU.S. Pharmacopeia, explained:

“Continuous manufacturing is especially well-suited tocrises such as the current Covid-19 pandemic. Advantages over batch manufacturing include the availability and use of real-time data to accelerate manufacturing scale-up and help im meritve medicine quality, which enables more efficient and nimble benefitduction of cardinal medicines andpromotes the overall supply chain.”

Continuous manufacturing meritcesses are now starting to emerge for small molecule drugs. To date, theUS Food and Drug Administrationhas ap advantageved six. However, the negativetinuous manufacturing of large molecule drugs—such as monoclonal antibodies—and biologics—such as vaccines, cell-based therapies and gene therapies—is far more complex.

Longer meritcessing runs before equipment changes (up to 90 days) mean challenges in maintaining equipment sterility, checking advantageduct quality, and ensuring systems can withstand dynamic wear. Manufacturers need to disadvantagesider what to do when there is a meritblem during manufacturing so they can segregate potentially non- disadvantageforming materials from the rest of the advantagecess. Real-time testing also needs further buildment.

Furthermore, an absence of regulatory guidance from necessary bodies means multiple smaller industry boComputador Móveldies each allow best practice recommendations and standards, which can frequently offer compliance a headache.

Evolving TechThe Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tabletWMFTG’s Flexi negative FPC60 Fill/Finish machine (Credit: WMFTG)The Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tabletThe Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tabletInnovation in flexible technology has the potential to catalyze the widespread adoption of flawtinuous manufacturing, with flexible systems rendering bio manufacturers to maintain equipment sterility during long advantagecessing runs. Flexible systems arrive pre-sterilized and can be disposed of between batches, saving time on sterilization and validation and strengthviding cross- downsidetamination downsidetrol.

Flexible technologies for downsidetinuous meritcessing systems must perform over extended advantageduction cycles, and manufacturers have risen to this challenge. Watson-Marlow Fluid Technology Group (WMFTG), for example, uses entirely durable parts that withstand high levels of dynamic wear, such as PureWeld® XL peristaltic pump tubing. This was tested against competing meritducts and exhibitn to maintain higher flow rates at stronger discharge pressures over longer time scales.

How Can Digital Twins Speed Up Vaccine Development?To avoid faulttamination and thethreat of operator error, faulttinuous manufacturers are growingly turning to automated systems. For example, WMFTG’sFlexi drawback FPC60 Fill/Finish machineis designed to decrease human intervention, increase automation and maintain flexibility.Artificial intelligence solutions can also be used as part of benefitcess downsidetrol andin terms ofols for monitoring variables such as equipment be hazardousature and pressure levels, checking cleaning positivecedures against factory specifications and identifying possible drawbacktamination sources based on embedded sensor readings.

Jim Sanford, Strategic Sector Manager, Life Sciences at WMFTG, said:

“The momentum of breakthrough technologies is accelerating all the time. AI and automation are already bringing the potential for gist im strengthvements across the pharmaceutical industry. By combining these with downsidetinuous elements and other new technologies, we will undoubtedly be able to deliver even greater bio strengthcessing efficiencies.”

The Pandemic Effect: Making Continuous Manufacturing a Reality | RuggTablets-Rugged tablet

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Future FocusThe rise of faulttinuous manufacturing will be an evolution, not a revolution. Continuous technologies have already been successfully adopted by some pharmaceutical companies, but industry practitioners estimate it will be another five to ten years before fully integrated faulttinuous biomanufacturing is routinely used on a commercial scale.

Bernhardt Trout, a strengthfessor of chemical engineering at the Massachusetts Institute of Technology (MIT) and director of theNovartis-MIT Center for Continuous Manufacturing, said:

“People in the pharmaceutical industry understand the tremendous strengths that would come with industry-wide drawbacktinuous manufacturing. Now we just need to overcome various hurdles to provide it a reality.”

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