Single-use technology allows pharmaceutical plants to use dedicated manufacturing systems for each batch. How does this option affect patient treatments and access to medicines?
Enhancing Responsiveness to New or Changing Diseases
The COVID-19 pandemic and the continued emergence of new variants have shown the world how new health threats can seem to arise overnight. Fortunately, pharmaceutical companies are well-positioned to help, especially if those businesses rely on single-use technologies.
Image: Bioreactor. By GYassineMrabet CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=8301774
When a new 400,000-square-foot facility opened in Tennessee, it was one of the largest dedicated to single-use technology. Executives said the new site was part of a $650 million bioprocessing production investment over multiple years through numerous targeted efforts.
By Ellie Gabel.
They also mentioned how single-use technology supports biopharmaceutical processing in reacting quickly to new health issues. From patients’ perspectives, these benefits mean they could access urgently needed treatments sooner.
Additionally, single-use technologies make individual companies less dependent on supply chain difficulties, which often worsen once disease experts detect new threats. Executives associated with the Tennessee facility appreciated how single-use technologies have fewer physical space and product requirements, allowing production to occur faster and more cost-efficiently.
Improving Productivity Through Less Downtime and Better Processes
Many biopharmaceutical plant leaders frequently explore practical ways to increase facility productivity. They know succeeding will boost the bottom line by maximizing output. When workers are more productive, they can often get more done with the support of fewer coworkers. That’s a particularly useful benefit as many companies simultaneously cope with labor shortages and more customer demands.
The productivity improvements associated with single-use systems often occur because production happens with fewer, shorter stoppages. For example, line-based changeovers for stainless-steel bioreactors can take 10 hours, even when people intend to make more of the same product. The time frame extends to 21 days for changeovers related to different items.
However, the downtime is much shorter for single-use systems because people dispose of the components after each batch. It only takes a few hours to handle the changeover for a single-use bioreactor, allowing companies to be more flexible as manufacturing needs fluctuate.
Specific single-use components can also accelerate formerly time-consuming process steps. A mixing system using single-use bags allows people to combine ingredients in only 15 minutes, saving time without sacrificing quality.
Patients benefit because greater productivity shortens the time before they can avail of treatments. Products arrive on the market sooner, and the makers can better cope with demand surges, reducing the likelihood of delays and shortages.
Reducing Contamination Risks and Boosting Safety
Pharmaceutical plants must maintain stringent cleaning protocols, especially when using permanent equipment to make several products. Otherwise, the companies are more likely to deal with contaminated goods that could harm patients and damage a brand’s reputation.
Contamination found during regulatory inspections can also attract scrutiny and hefty fines. In one case, an FDA inspection of an Indian facility included eight observations detailed in a 27-page letter. The contents revealed some equipment had drug remnants as high as approximately 800 times the acceptable limits. Many cited issues centered on a lack of appropriate sterility and equipment cleanliness.
Single-use equipment does not eliminate contamination threats, but it minimizes them. That’s largely because there’s no need to clean the components after producing batches. People simply discard them.
Patients and their treatment teams benefit from increased product safety. All medical interventions come with risks such as side effects or adverse medication reactions. However, suppose the people taking or recommending those products can feel confident in safe production practices. In that case, they’ll feel more at ease about those pharmaceuticals and more willing to stick with prescribed regimens.
Supporting Personalized Medicine and Targeted Therapies
More health care practitioners and researchers are getting more interested in personalized treatments based on a patient’s genome. Prescribing such targeted treatments could give patients the best outcomes and increase their chances of getting prescribed the right drugs at the correct times.
Personalized medicine has also shown people new, better ways to utilize medications that are not performing well in clinical trials. In one case, a breast cancer drug that failed Phase II clinical trials may work better for specific patients. Research indicated about 40% of patients with triple-negative breast cancer had tumors with high levels of particular sugars.
Additionally, the same drug that didn’t do well in clinical trials bound well to those tumors, suggesting it could accumulate inside and target cancerous cells. Such results might mean the drugmaker must handle smaller production runs. However, single-use technologies make that much easier and more financially feasible. Their greater adaptability helps pharmaceutical companies provide drugs for smaller numbers — or even individual — patients.
Single-Use Strategies Keep Pharmaceutical Companies Patient-Focused
These are some of the many ways single-use technologies can ensure pharmaceutical companies can cater to the patients depending on them. When that happens, those businesses will stay competitive while increasing their profits and improving people’s trust.
Single-use products also align with the pharmaceutical industry’s fast-changing nature. They help companies release new products faster or change existing ones to meet emerging market needs. Although this overview centered on patient benefits, there are plenty of company-level advantages to enjoy, too.
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