Meeting Complex Biopharma Analytical Needs

Analytical techniques such as mass spectrometry (MS) and liquid chromatography (LC) can help to provide vital insights into the composition, quality, stability and safety of biotherapeutics throughout the product development timeline.

However, despite continued advancements, challenges remain, and there is a need for the development of high-precision analytical tools sensitive enough to detect changes in protein structure or toxicity resulting from denaturation and aggregation of biomolecules.

Technology Networks recently had the pleasure of speaking to Dr. Martin Vollmer, biopharma program manager within the Life Science Analysis Group at Agilent, about some current analytical challenges the biopharma industry faces and how they are being addressed. We learned about some exciting advancements in analytical technology, Agilent’s customer-centric approach to developing new analytical instruments and partnerships between Agilent and other companies to drive improvements in sustainability across the biopharma industry.

Isabel Ely (IE): Can you outline some of the primary analytical challenges currently faced by the biopharmaceutical industry?

Martin Vollmer (MV): Major challenges for the biopharma industry are long development times, high costs and highly complex testing requirements. The consequences for companies such as Agilent to address these customer needs are to simplify the usage of analytical equipment, to increase robustness, to eliminate failures and to provide customer-centric end-to-end solutions. Our goal is to achieve this through constant interaction with the customer and to get early feedback during design and development.

IE: In your view, how do recent advancements in analytical technology address these challenges?

MV: Increased automation and simplification can be experienced with many of our solutions. Let´s take the new Infinity II 1290 Bio Online LC solution. This system can analyze samples directly from a bioreactor or a purification setup and trigger action in an automated fashion. Sample scheduling, method setup, results flagging and trending analysis can be managed by operators who do not need to be chromatography experts. This saves time and minimizes human intervention and errors.

A second example is the AssayMAP Bravo, where tedious sample prep necessary prior to LC or LC-MS analyses can be configured to increase reproducibility and significantly speed up the complete workflow. Offering complete solutions such as automated sample prep, intuitive software and guided analysis, including consumables fitting seamlessly into the workflow, is already significantly reducing these challenges.

IE: How does customer feedback influence Agilent’s development of new analytical instruments for the biopharma sector?

MV: Agilent uses many vectors to ensure continuous customer feedback for product improvements and new developments. We live a customer-first philosophy. Just to mention a few of them here are early access programs for new products, co-creation projects from early development on, and strategic collaborations with customers and industry partners. For the online LC solution, we are, for example, working with Merck-Millipore to combine expert knowledge from the analytical and process worlds.

In addition, we use our influencer community – a board consisting of many analytical experts from industry – to conduct quick surveys on customer challenges and needs. We also conduct anonymous market surveys with the press to receive unbiased input, and we use our Field Service organization, which is, per definition, in constant customer exchange, to provide constant input on current products and future products.

IE: What strategies does Agilent employ to ensure that innovation in instrument design is aligned with the evolving needs of the biopharma industry?

MV: Our paradigm here is to interact with the end-user as much as we can and as early in the development process as we can. This helps us to uncover bottlenecks and unmet needs. We also carefully follow the trends and emerging needs of the industry, and as mentioned earlier, we provide early access and collaborate. For example, when COVID-19 started it soon became clear that sample prep is a severe limitation. We were able to provide an automated sample prep solution with the Bravo platform very quickly.

IE: In an industry that benefits from interdisciplinary approaches, how does Agilent facilitate collaboration across different instrument divisions to meet complex biopharma analytical needs?

MV: Agilent has implemented a product development life cycle with the intent to ensure cross-business alignment to develop customer-centric products. A prerequisite is to own in-house, of course, a broad portfolio of different technologies and solutions covering as much of the analytical space as possible and renew and enrich this portfolio constantly.

Within the product development life cycle projects are conducted with a matrixed team. With this approach, we define from the beginning of the development all business units that need to be involved to develop a complete customer-centric solution. Program and product management tools and defined checkpoints are in place to ensure appropriate representation during the different phases of development. Last but not least we have cross-business strategic program offices, a cross-divisional marketing board and a field advisory board in place to ensure governance of these processes and programs is ensured at all times.

IE: How do you see AI and ML tools impacting biopharma projects?

MV: AI and ML tools will increase significantly in importance for the biopharma industry but also for analytical solution providers. Very recently the World Economic Forum’s Global Lighthouse Network named Agilent’s facility in Waldbronn a Fourth Industrial Revolution (4IR) leader for effectively deploying innovative technologies at scale in the manufacture of scientific instruments. The Lighthouse is an initiative of the World Economic Forum in partnership with McKinsey & Company to showcase models of smart manufacturing enabled by 4IR technologies such as AI and ML, robotics, data analytics and the industrial Internet of things.

But let´s look at the operational aspects of analytical testing equipment for biopharma customers specifically. Take, for example, sample analysis. On one hand, you have the instruments that will intrinsically come with more designed-in intelligence, helping to track samples from the point of preparation until the analysis data is generated and stored. It will help to eliminate human-introduced errors.

Then there are instrument status and health checks to trigger preventive maintenance and, of course, also aid with and speed up method optimization. The other equally important aspect is making use of data in the most efficient manner by using AI to store, aggregate, find and combine sets of data to achieve superior outcomes. Altogether, AI combined with intelligent analytical solutions will accelerate drug development and QA/QC and finally result in faster time to market and lower costs.

IE: How are you partnering with biopharma labs to improve their sustainability?

MV: Sustainability is a top priority in our company philosophy. We do not only strive for our own internal sustainability goals but also to help our biopharma customers around the world to become more sustainable. This is, for example, reflected in the fact that scientists around the world elected us in 2023 to be the most sustainable supplier of laboratory equipment, reagents and testing solutions.

But let´s be more specific. During instrument development and manufacturing, we do everything we can to reduce our carbon footprint. For example, the new generation of sample coolers for Agilent´s LC autosampler consume a factor of 2.4 less electricity. We are intentionally considering energy consumption, material choice and operational excellence in the design of every new product. We are also well known for the robustness and quality of our products. In addition, we have our certified pre-owned business where we take back used instrumentation and refurbish them such that there are no sacrifices on performance and that they continue to be operational for many more years. This is an important contribution to circular economy.

We are also supporting our customers on the operational side. Migrating standard LC methods to UHPLC according to USP621 helps to save up to 84% of solvents: start-up and shut-down procedures, smart method development, e.g., with blend assist, overlapping injections and early maintenance feedback help to reduce consumption of organic solvents or to reduce idle times between analysis.

We are also putting emphasis on transparency. We have undergone certification by My Green Lab, a nonprofit organization that aims to improve the sustainability of scientific research. Many of our instruments now carry the ACT label as an identification mark. These ACT labels (Accountability, Consistency, Transparency) help customers to choose safe and sustainable products by providing information about the environmental impact of a lab product and its packaging at manufacturing, usage and disposal.

IE: Looking forward, what do you see as the next big challenge or opportunity in biopharma analytics, and how is Agilent preparing to address it?

MV:

a.      As mentioned above, implementation of ease of use, automation, AI and increased robustness is paramount, especially in times when reducing costs and lack of qualified personnel are severe challenges. Agilent is active in all of these fields, and we ensure that for all new products, this has high priority.

b.      The increase in the variety of drug modalities also poses analytical challenges. If you imagine how different new generations of mAbs, mRNAs, oligos, therapeutic peptides and cell therapies are, it will be highly important to closely follow the analytical requirements for the key workflows, identify the bottlenecks and use customer input constantly to improve current platforms and develop true end-to-end solutions. While mAbs were the hottest topic for many years, with Covid, suddenly mRNA therapies appeared. Now, after Covid, therapeutic peptides and cell therapies are gaining traction, highlighting the breakthrough science has made over the last years. This requires close cooperation with the biopharma industry but also with the regulatory agencies to provide and develop the best solutions to fulfill their needs and requirements.

Dr. Martin Vollmer was speaking to Isabel Ely, Science Writer for Technology Networks.  

About the interviewee:

With an educational background in biochemistry and molecular biology, Dr. Martin Vollmer has worked for Agilent for 22 years. Previously holding positions within the company in research and development (R&D), project management, marketing and product management, since 2019, Martin has taken on the role of biopharma program manager within the Life Science Analysis Group at Agilent. In this capacity, he is responsible for shaping the strategic direction of Agilent’s offerings in the biopharma end-market and coordinating customer-centric solution development across multiple instrument divisions.