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Increasing pressure on R&D labs to lower prices and increase performance continue to raise the stakes across the globe. While the U.S. and European manufacturers have been leading the automation-driven performance improvement and innovation effort for years, China is making a concerted effort to capture that position.
Health and pharmaceutical news in China continues to highlight the impact on public health and reputational damage of complex and critical manufacturing processes. The potential effect of these recalls is widespread. For instance, major drug producer, Changchun Changsheng Biotechnology violated standards in making more than 250,000 doses of mandatory vaccines for Chinese children. Now as a result, the company is under investigation for fabricated data related to the production of vaccines for diphtheria, tetanus, whooping cough and rabies. In addition, last year, the same vaccine (produced by a different company, the Wuhan Institute of Biological Products), was found to have fallen short of prescribed standards.
Moving beyond vaccines, FDA announced the voluntary recall of several products containing the common blood and heart drug Valsartan, including those manufactured by Chinese bulk manufacturer Zhejiang Huahai Pharmaceutical, due to the detection of an impurity linked to cancer.
Despite these high-profile and critical missteps, China is still in position to capture a significant lead in global pharmaceutical production, especially if it commits to large-scale automation and concomitant process improvement. Automation, which includes robotics in both test and production, is designed to mitigate the risk of human error and use cases consistently demonstrate that it also improves efficiency, along with overall lab performance.
Global pharmaceutical companies have been leading the way with advanced automation, and, to a certain extent, robotics. The next opportunity is to deploy smaller and more agile robotics systems in smaller footprints – not just in large-scale production settings, where the initial investment is millions of dollars.
The newest benchtop robots solve immediate problems, focusing on repeatability – critical for the success of any scientific experiment. In most labs, scientists are still spending an average of two hours per day on routine pipetting which brings human error into play. Robotics eliminates that risk, improving yield and overall output, as well as greatly reducing the risk of worker injury.
The price/performance ratio is compelling: The cost of these systems starts at about $25,000 USD, can be put in production within a few hours, and more often than not, require little to no previous robotics or programming experience. The upfront investment is a fraction of that for the traditional automation systems and is typically recovered within 12 months.
Even as tariff penalties are still in flux, some things are clear: China is investing more in R&D; and its $571B pharma market is expected to hit $1T by 2020. That will create a significant opportunity for China-based companies to invest even more in automated drug research and production.
In the US and EMEA, where processes are more controlled, regulations and pricing pressures continue to tighten. The best way to maintain this lead is to expand the opportunities for automation. Robotics give mid-size and even small labs important new ways to achieve competitive parity; smaller companies’ natural ability to bring innovation to market more quickly creates a sustainable advantage. From Bradford assays to toxicity dose testing, robotics can help pharmaceutical companies increase reproducibility and accuracy up to 10 times current levels.
Not moving forward also has risks, even for established companies, especially those reliant on blockbuster drugs. AbbVie Inc. and Celgene Corp., for example, both saw punishing stock market responses earlier this year, after R&D setbacks resulting from ineffective trials.
Unfortunately, it’s not uncommon for flawed data to make its way into scientific literature and subsequently be used as the basis for clinical trials. Eventually it becomes clear that preliminary test data was wrong, and the entire process needs to be scrapped – a situation that can cost between $690 million and $1.2 billion, depending on at what phase the flaws are identified. Lab automation can all but eliminate the errors in preclinical data by taking the human element out of the equation and ensuring accuracy through reproducibility. Improving reproducibility extends to drug development cycle, optimally creating a broader and faster runway for new drug development.
As China looks to continue investing in pharmaceutical R&D, one thing is certain – automation tools are critical for the future of drug development. Lab automation can make drug development less expensive and more effective. Technologies like liquid handling robots and intelligent pipettes, among others, will help companies validate their emerging data, leading to more efficient and affordable drug development, not to mention making reproducibility of data more achievable than ever.
Piero Zucchelli is CEO and Chairman of the Board of Directors of Andrew Alliance.