Addressing Quality Management: Strategies to Reduce Production Costs and Biologics Shortages

4-22-13

Ensuring better-managed stocks of high-quality vaccines is the key to addressing large-scale outbreaks. Image Source: Flickr User CDC Global Health

Over the last couple of years, there have been massive outbreaks of nightmarish illnesses such as Zika virus, Ebola, Yellow Fever and the resurgence of both measles and mumps. Many of these illnesses may be vaccinated against or treated with biologics that are currently available.  But many biologics companies are hovering on a precipice. Having bacteria or other living systems manufacture your biologic therapies on your behalf is far more complicated when it comes to mass production as compared with production of regular drugs, such as small molecules or peptides; should there be an outbreak, will there be enough therapeutic to treat everyone?

In the last year, the FDA decided to allow doxorubicin, a chemotherapeutic agent chemically semi-synthesized from a bacterial species, to be imported from a banned facility in China.1 This is an extreme measure because this company was banned on the basis of poor compliance. All the drug companies that are using this compound will be testing it in the United States, of course, before producing a final product, but having to resort to this extreme is just a symptom of a much larger issue that needs to be dealt with. Fortunately, there are a number of steps that can be taken to avoid catastrophic shortages that require importation from banned overseas facilities.

Working Together to Predict Need

Larger pathogen outbreaks may be deemed a health emergency when there are inadequate stocks of therapeutics, which leaves many patients and physicians in the lurch. But with the aid of advanced software, many advisory companies and disease-alert services are working to better predict where and when the need for biologics will occur. Many mosquito-carried disease experts are currently occupied with the Zika outbreak in South America, but there was another recent mosquito-based threat, Yellow Fever (YF). This particular disease is related to Zika and dengue, which is a terrifyingly debilitating illness, and it has a working vaccine, but is not treatable once it sets in. An external service, ProMED, used innovative software to model the movement and transmission rates of the disease, then compare it against yearly production of YF vaccines. A warning was issued stating that, provided with a perfect storm of proper climate and the correct mosquitos, “hundreds of thousands could die before YF vaccine stocks could be boosted and delivered.”2

This is horrifying. Fortunately, a couple of companies diverted their efforts away from production of other routine vaccines and it appears that the spread of YF is under control. That said, better communication regarding stock levels and streamlining a company’s ability to ramp up production will help in future incidents where meager warning is given.

Of course, the ideal, though, is that companies do not need to stray from production and distribution of routine vaccines since that has the potential to lead to a whole slew of other complications down the road. There is a major breakdown in communication and poor efficiency within and between facilities. Workflows need to take into account that it is biologics that are being dealt with, not peptides or otherwise synthesized drugs. If there are complications with a species or strain, it needs to be better communicated so that other facilities can absorb the deficit. With a common computer platform, numerous facilities could coordinate stocks and ensure that production was focused on what is needed and that all those biologics nearing the end of their lifespan could be moved to facilities and used, rather than wasting away in storage. This would help mitigate many of the aforementioned situations. Through the use of modern lab technology, workflows will be easier to manage ensuring that all necessary biologics are being produced in the most efficient manner.

More Efficient Management at the Manufacturing Level

Prediction and preparation are some of the best ways to combat shortages, but this isn’t easily done at a manufacturing level. There are a number of simple steps that can be taken at the manufacturing level, in the absence of predictive measures, to prepare accordingly for larger scale requirements3:

  • Effective management of raw materials may permit a more rapid increase of production. Many precursors are produced overseas and in the event of an outbreak or an illness, it may take days or weeks to get the precursors for biologics that take weeks or months to produce. Additionally, low quality raw materials may lead to recalls and subsequent shortages.
  • Better management of drug inventory systems will assist manufacturers in preventing drug delivery disruptions. In most industries, the prefered modus operandi is to stockpile product leading to more efficient sales; however, in pharmaceuticals and biologics, there are different economic constraints that lead many manufacturers to attempt to operate at optimal efficiency (minimal output). This is problematic when demand increases rapidly, as many biologic therapies cannot be made quickly. Better management of final product quality can also help manufacturers overcome the quality testing bottleneck.
  • Efficient multi-facility communication may mitigate sudden shortages or poor allocation of resources. Many companies have multiple facilities, but due to lack of communication, resources needed in one facility may never be relocated from another one.

Fortunately, there’s really only one component that’s missing in this equation: a single platform that allows researchers and manufacturers to streamline and track their efforts. BIOVIA ONE Quality helps manufacturers ensure quality and increase productivity by streamlining and better tracking workflows and batch information. This comprehensive system enables better materials and finished product management in one standard platform that can house standard operating procedures, batch information, quality documentation and compliance data. As illnesses such as Yellow Fever continue to spread, better quality and stock management at the manufacturers level will save countless lives. Please contact us today to learn more about how our software options can support the efforts of your lab.

  1. “Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant,” July 21, 2016, http://www.bloomberg.com/news/articles/2016-07-22/facing-cancer-drug-shortage-u-s-relies-on-banned-chinese-plant
  2. “W.H.O. Calls Yellow Fever in Africa ‘Serious Concern’,” May 19, 2016,  http://www.nytimes.com/2016/05/20/health/who-yellow-fever-africa.html?_r=0
  3. “Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider,” 2013, http://gabi-journal.net/steps-to-ensure-adequate-supply-of-biological-medicines-considerations-for-the-healthcare-provider.html