At all stages of a pharmaceutical or biopharmaceutical’s lifecycle, from development right through production to ongoing quality control and monitoring, it is vital that analysts are able to make precise and sensitive measurements on a range of parameters, in numerous sample types, sometimes on tiny quantities of material and in a time and cost efficient way. This is no easy task. On top of this, they must also be able to do that in such a way that maintains data security but enables traceability and compliance in this heavily regulated sector.

We spoke to Geoff Winkett, vice president of molecular spectroscopy at Agilent, and Michel van den Berge, senior marketing director for molecular spectroscopy at Agilent, about the concerns they hear from their customers in the pharmaceutical and biopharmaceutical sector and how they are helping to address them.

Karen Steward (KS): To give readers a bit of context, can you tell us about the focus of the molecular spectroscopy team at Agilent?

Geoff Winkett (GW): In molecular spectroscopy, our focus is to provide innovative solutions for the pharmaceutical and biopharmaceutical segments, the general laboratory market encompassing energy and chemical, material, academia and environmental analysis and the field detection market in areas such as aviation security and portable field testing.

However, our number one strategic area of focus is the pharma and biopharma industry. The majority of our investment is going into that area in terms of mergers and acquisitions – for example, we acquired Cobalt Light in 2017, which gave us a presence in Raman spectroscopy and led to our site on the Harwell Science and Innovation Campus being established – as well as in research and development (R&D). Over the last two or three years, we’ve invested heavily in introducing innovative solutions, addressing pharma and biopharma customer challenges.

KS: Can you tell us about some of the challenges your pharmaceutical and biopharmaceutical customers are experiencing and how Agilent is working to address them?

GW: One of the biggest challenges that we see today from our pharma customers is the whole issue of data integrity, security and compliance. We’re all very concerned about who can gain access to the data we have in our organization. Therefore, we've made some key investments in that area.

We recently released an updated version of the software that runs our Cary 3500 UV-Vis spectrophotometer, one of our leading products in the pharma and biopharma market, which addresses compliance. Our original release used a workstation-based PC approach, but the new version uses a server-based approach, which is compatible with Agilent’s OpenLab platform.

Fundamentally, the software contains all the controls that a customer needs to keep the data secure. When they're pulling data off the network as part of testing, it has all the controls around signatures, access administration tools, electronic signature workflows and audit trails built-in as part of the software. There are two facets to what this provides: it gives the customers confidence that their data is going to be secure, and it also helps ensure they meet the regulatory requirements. In highly regulated environments, which pharma and biopharma operate in, regulations vary depending on which global region they are in, and our software ensures that they can comply with those regulations. It's a complex area, it's growing, and regulatory concerns are only going in one direction. Therefore, it’s an area that we’ll continue to invest in to give that peace of mind. We see the pain points from the customers and in response, we ensure that the products we bring to market address their needs in this area.

KS: Are there any additional benefits to using software solutions that are compatible with network-based suites such as OpenLab?

Michel van den Berge (MvdB): The networking capability of OpenLab enables our customers to connect multiple systems on the same server. Previously, they would have had a UV spectrometer here, a UV spectrometer there, each with their own computer that runs it and stores the data separately. Now, it's all stored centrally so that the challenge around security is much easier to manage. It's also the same software that our customers use for other analysis systems, such as high-performance liquid chromatography (HPLC). This is the first foray for molecular spectroscopy into the OpenLab system.

Lab managers often tell me that their role has changed from managing the lab, checking instruments are working and helping with method development, to becoming IT people.

KS: The pharma and biopharma sector can be very competitive, how are you helping your customers in this area meet demands?

GW: Increasingly what we're seeing is, and I guess it's not too much of a surprise, that it's about helping our customers improve their time to market and reduce the cost of ownership whilst ensuring compliance. For drug manufacturing companies, it's about getting the product through the R&D cycle, through the quality assurance (QA) cycle and into production quicker, so that they can start to realize the benefits from these huge investments that they're making into these drugs. We see this trend as so many of our products are focused on supporting the time to market and reducing cost. For example, two years ago, we brought out a raw materials handheld ID analyzer, the Agilent Vaya, which is a Raman-based instrument designed for the pharma and biopharma market. It’s designed to be used in the warehouse for testing incoming samples to ensure that the raw materials are what they should be and that there are no issues.

Essentially, this involves scanning the incoming raw material package and it will run a quick measurement through the packaging or container to inform the user if what’s inside is as it should be. It’s quick, easy to use and effective, allowing our customers to improve the incoming inspection process. That gets production flowing quicker and consequently, the product out to market quicker too. That’s the innovation that we brought to the market, and there’s no instrument today like it for raw materials or products.

KS: How does this solution compare to existing testing options?

GW: Traditionally, samples would have to be taken for lab-based testing, requiring other instruments that used chemicals or the addition of substances like water. These all take a lot more time and often require the containers to be opened. The beauty of our product is that it works through barriers, so we don't need to open the packaging or container, we can just take measurements directly. It sounds like a simple thing but for some of these big warehouses with 1000s of raw materials coming in, it's a really important part of improving their workflow. We saw that need, which is why we invested heavily to bring that product to market.

Similarly, the Cary 3500, which often sells into R&D, QA, and quality control (QC), really speeds up the development time. As they're going through the QA/QC process, things like the thermal melt feature, which is a critical part of the process they need to go through in order to release the drug, are much faster and cheaper than existing methods. We brought out the Cary 3500 a couple of years ago, but we continue to introduce enhancements and help labs and QA managers do their jobs a lot more easily and cost effectively.

KS: How do you see the future of molecular spectroscopy for Agilent in the UK?

GW: This is a market we're very committed to, see significant potential for our solutions and thus will continue to invest in. Our Harwell facility in the UK is critical and in fact is the global headquarters for our Raman business. When I think about the number one strategic focus for this business, which is pharma and biopharma, Raman spectroscopy solutions have a huge role to play. We've made a big investment in this site already; we are well on the way to filling it up and we're actively hiring people right now. Molecular spectroscopy is a huge opportunity for the business and we're very focused on investing in and driving that success.

Geoff Winkett and Michel van den Berge were speaking to Dr. Karen Steward, Senior Science Writer for Technology Networks.

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