Future-Proofing Pharmaceutical R&D to Accelerate Aerosol Science Innovation

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 Future-Proofing Pharmaceutical R&D to Accelerate Aerosol Science Innovation

The Chiesi Group of laboratories focuses on the research, development, production, and commercialization of innovative medicines in the respiratory, neonatology, rare disease, and special-care therapeutic areas. In 2009, Dr. David Lewis founded the company’s Chippenham, U.K., office and tasked the researchers there to continue to develop products at the cutting edge of aerosol science, with a focus on pressurized systems. Chiesi Chippenham has invested heavily in multiple disciplines related to drug discovery.

According to Dr. Lewis, director of Aerosol Research, Chiesi Chippenham, “Our objective is to ensure we know as much as we can about inhalation drug delivery. We need to be 5–10 years ahead, so a product could be launched on the market in 5–10 years. That means we need to be 20–30 years ahead in the research to make that happen.”

Dr. Lewis is co-inventor of 29 patents relating to pressurized metered dose inhaler formulations and devices. These inventions resulted in the Chiesi Modulite technology, which led to commercialization of formulations of beclomethasone dipropionate, budesonide, formoterol, and a beclomethasone dipropionate-formoterol combination in several European countries.

Chiesi’s focus on entrepreneurial collaboration serves as the basis of the 10-year relationship between its researchers and Waters. Dr. Lewis noted the importance of working with the right partners: “We need to find the right people who have the right mindset and understand what we want to do. Waters is easy to work with. It’s about the people and what they can offer.”

That mindset includes a focus on the specific needs of drug discovery researchers. “Waters works hard to ensure its instrumentation is suitable for the pharmaceutical industry. It’s a lot of work to achieve software that does what we need it to do. Waters provides the tools that we need to do our jobs—and they enable us to do our jobs well,” said Dr. Lewis.

Breaking boundaries in drug discovery research

In 2014, Chiesi Chippenham invested in Waters ACQUITY UPLC, with SQD and QDa, and informatics software, with the aim of reducing analytical bottlenecks in its workflow (see Figure 1). The Chippenham team noted that it spent more than nine hours on its process analytical technology (PAT), the majority on sample analysis, where sample run time was more than six hours. This bottleneck impacted the working process. By investing in improved hardware, Chiesi managed to reduce analysis run time by more than five hours. Automating processes resulted in a reduction in the majority of paperwork and facilitated automated approvals. In addition, automation resulted in faster assay run time, higher sensitivity, and high-speed assay development—resulting in fewer delays, efficient workflow, and reduced paperwork—contributing a time savings of seven hours per day.

ImageFigure 1 – Waters instrumentation used at Chiesi Chippenham laboratory.

Chiesi Chippenham was looking for an instrument that both complemented and enhanced the team’s research. “If I’m getting a value out of an instrument, what does it tell me? If we interact with many different instruments, we get a bigger picture to make better-informed decisions,” explained Dr. Lewis.

Chiesi’s entrepreneurial culture means the company is continually evaluating new technology to see how it can improve current and future pharmaceutical product pipelines. Dr. Lewis saw the potential of using cutting-edge Waters UPLC hardware and chemistry with the Waters ACQUITY QDa detector to give the Chiesi Group a competitive advantage in the time-sensitive pharmaceutical industry.

Those improvements help Chiesi scientists stay focused on pushing the boundaries of drug discovery. Dr. Lewis said, “The QDa coupled with [the] UPLC system is keeping us in touch with the future. It helps reduce analysis time and increase productivity. The QDa is easy to use, requiring less user expertise. We’ve found it very useful.”

Another one of its appealing features is the QDa’s compatibility with Waters chromatography systems and optical detectors, as well as Waters scientific software products. That compatibility helps Chiesi streamline and simplify by combining mass spectral information seamlessly into the same workflow. The QDa gives more selectivity than optical detection alone, and therefore gives more confidence in the results.

Software solutions

In addition to Waters instrumentation, Waters Laboratory Informatics Software, Empower, and NuGenesis Lab Management System provides Chiesi Chippenham with a powerful suite of software solutions for instrument control, scientific data management, scientific search, network integration, and compliance management to streamline laboratory operations. That investment has resulted in significant benefits, particularly in terms of speed, automation, and advanced data tools. Faster laboratory workflows enable a higher level of data output—freeing up time for more important tasks. Automation prevents errors from manual data input and transcription. Additionally, all information is saved as meta data with identical formats for document descriptors, improving data searchability.

The Chippenham team relies on the Waters Empower and NuGenesis Lab Management System, which combines synergistic data, workflow, and sample management capabilities to support the entire product lifecycle from discovery through manufacturing. An integrated electronic workflow helps maintain the integrity of the data.

The capabilities provided by NuGenesis help Chiesi Chippenham’s researchers enable software integration and standardization without the complex, costly, and time-consuming deployments often encountered with traditional information management solutions—valuable because companies want to avoid large disruptions to their data-integration systems and the related costs, additional infrastructure, inevitable disruptions to workflows, and logistical issues.

NuGenesis also helps the Chiesi Group reduce costs, accelerate decision-making, improve laboratory effectiveness, and get products to market faster. Building a paperless laboratory from the ground up enabled Chiesi to avoid paper costs, build in all lab approvals with 21 CFR-compliant e-signatures, and streamline bottlenecks. Automation provided by the software reduces the likelihood of transcription errors and decreases time checking data. Dr. Lewis explained, “We need to process, interpret, visualize, and compare the most complex data, and then turn it into meaningful information quickly and simply.”

Maintaining consistency across R&D locations

Because the Chiesi Chippenham office works closely with its other R&D locations, maintaining consistency is an important part of its investment in Waters technology, both in its laboratory and across other R&D locations. By breaking up silos of information to encourage collaboration with other scientists, locations, and external partners, the Chiesi Group can extend the value of its research data and speed up the innovation process.

The Chiesi Group has found that using the same instrumentation and column chemistries across laboratory sites has many benefits, including easy method transfers, significant time savings, and simplified decision-making. The Parma Quality Control lab recently used the QDa in combination with the ACQUITY UPLC H Class to streamline five methods down to just one assay, saving substantial time, as well as reducing sample prep time and enabling faster batch release, reducing release from two days to 10 minutes. Chiesi scientists have also actively worked to get the time required for sample analysis down to just one minute.

The combination of the ACQUITY UPLC, QDa, chemistries, and informatics (Empower and NuGenesis) streamlines basic method development for companies like Chiesi, which in turn enables the completion of entire feasibility studies in significantly reduced time.

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