Building Up to a Bright Future

Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. “Dissolution is a very controlled, very precise, and required sample preparation technique,” specified Dan Spisak, marketing manager for the Dissolution Division at Agilent Technologies, during an interview with Pharmaceutical Technology Europe at the opening of the company’s Dissolution Centre of Excellence (CoE) facility in Craven Arms, United Kingdom (see article Agilent Sets Up Dissolution Testing Hub in UK). “The dissolution test is not going away; it is a required test in the pharmaceutical industry. Everyone making pharmaceutical products needs to run dissolution tests on their products prior to release.”

Modifying capabilities

Thanks to a variety of market drivers, dissolution testing is, in some respects, undergoing change. Some of the expansion and refresh of instrumentation within the area of dissolution testing is being seen as a result of reshoring, a trend that has picked up over the past few years, Spisak stated. “This reshoring helps protect companies from unexpected issues—like pandemics—that could affect critical parts of the supply chain and drug release process,” he said.

But the generics sector is driving the bulk of growth in the field, Spisak stressed. “The lower-cost generics increase the level of healthcare to address the needs of the growing ageing population, especially in emerging markets,” he noted.

However, there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. “For that reason, it is becoming necessary to modify the capabilities of what can be done [in dissolution testing],” he said.

A prime example of how instrumentation is being updated could be seen within the modernized CoE facility (Figure 1), which incorporates multiple systems that have been designed to work with novel formulations, such as nanoparticles. Novel formulations can pose challenges when using standard apparatus; nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. Therefore, modification of the instrumentation, such as that found in Agilent’s NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.

Additionally, in instances where medical device companies need to perform dissolution testing, challenges can be encountered as a result of a lack of knowledge about the sample preparation technique—such companies can be unfamiliar with dissolution—Spisak continued. “We often encounter ‘homemade’ devices being used in the laboratory which can be very labour-intensive and difficult to transition into a quality control environment,” he stated. “Agilent has developed the 400-DS model specifically for these types of products. This instrument complies with United States Pharmacopeia and is ideal for products delivering small amounts of drug over weeks or even months, such as drug-coated stents or implants.”

Automating processes

Looking at the overarching dissolution environment, there is the obvious trend of automation, Spisak noted. In a dissolution lab, there are typically entry-level chemists at work, and so, automating processes can ensure that potential errors are avoided, he explained.

A primary aim for Agilent Technologies is to create a digital lab, free of paper and pens and, ultimately, easier to use while also limiting errors, Spisak asserted. “Then, on the back end, for the lab in general, there are data and traceability for all the actions performed,” he said. “So, when it comes to data integrity and compliance, when the lab gets audited for example, everything is readily available.”

Another facet to consider is the efficiency that automation can offer; although, this aspect is certainly not unique to dissolution, emphasized Tom Van de Goor, director R&D, Agilent Technologies during the interview. “It’s not that each business needs to invent the wheel again, but to build upon the infrastructure and automate the workflows already available,” he said. “This work is something that Agilent feels is very important because not only are customers asking for it, but if a company is not participating in automating processes, then at some point in time they will be left behind.”

A virtual reality

Engagement with customers on a virtual platform has certainly become more acceptable in recent times, perhaps a change that has been accelerated as a result of the COVID-19 pandemic and the resultant necessity to continue operations in a virtual capacity. What virtual opportunities allow is for instantaneous connection, not just for sales, but also in instances where issues may arise and an expert can help to troubleshoot, explained Spisak.

“Even before COVID, Agilent had a very strong initiative to offer remote training and knowledge sharing,” said Steve O’Donohue, director of Agilent Technology’s Craven Arms site, during the interview. Through using a video room and virtual communication platforms, it is possible to improve efficiencies and share knowledge with the customer base, he stated.

“COVID has been a world leveller,” asserted O’Donohue. There was so much innovation being driven within Europe to tackle COVID that the region was able to advance forward in the ‘driving seat’, which has possibly left the region in a better place than some others to continue that momentum, Steve added.

“The pandemic was a driver for developments that would have taken much longer normally,” added Van de Goor. “New tools have come into play; in some areas, virtual reality is being used for demos or there are maybe more configurators for instrumentation. So, these things were more or less born in this time; although, they were probably in the planning already for a longer period of time but were accelerated because those were the tools needed to continue interacting with customers. A very positive outcome of this pandemic has been the acceleration of this whole digital transformation of how we work.”

About the author

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 12
December 2022
Pages: 27–29

Citation

When referring to this article, please cite it as F. Thomas, “Building Up to a Bright Future,” Pharmaceutical Technology Europe 34 (12) 2022.