Building on the success of this initial partnership, on June 4, 2023, Waters and Sartorius announced a new phase of their joint efforts. This time, the collaboration focuses on supporting downstream bioprocessing—a critical aspect of the biopharmaceutical manufacturing process.

In this exclusive interview with BioPharma APAC , Guillaume Bechade, Senior Manager – Biologics Marketing at Waters Corporation, and Geert Lissens, Head of Product Management Separation Systems at Sartorius, shed light on their collaboration in the field of upstream and downstream bioprocessing analytics. With a shared goal of addressing the challenges of cost reduction and improved productivity in the BioPharma industry, Waters Corporation and Sartorius are working together to provide advanced solutions and streamlined monitoring experiences for customers. By leveraging innovative technologies and optimizing data exchange between their respective platforms, they aim to empower process development scientists and enhance decision-making capabilities. This interview explores the specific bottlenecks and inefficiencies in current bioprocessing practices and discusses strategic interventions for overcoming them. Additionally, the interview highlights the potential of real-time monitoring, process analytics, and continuous bioprocessing in transforming the efficiency and profitability of the BioPharma industry.

1. Could you please provide an overview of Waters Corporation's collaboration with Sartorius in the field of upstream and downstream bioprocessing analytics? How does this collaboration aim to address the challenges of cost reduction and improved productivity in the BioPharma industry?

For downstream bioprocessing, Waters Corporation and Sartorius are collaborating to provide customers with advanced solutions, streamlined monitoring experiences, and valuable insights for informed decision-making in upstream and downstream bioprocessing analytics.

The collaboration involves co-marketing efforts, generating comprehensive application data, and modifying the software of the Sartorius BioSMB PD multi-column chromatography platform to establish a feedback loop with Waters Patrol UPLC Process Analysis System for dynamic loading.

This builds on our previous collaborative work that facilitated the transfer of bioreactor sample data and analytical results between Sartorius Ambr multi-parallel bioreactor platforms and the Waters BioAccord LC-MS system. By co-locating these instruments in upstream bioprocessing labs, analytical turnaround times were significantly reduced as compared to the more traditional process of sending out samples to core analytical labs for the data needed for point-of-need decision making. By empowering process development scientists to generate process quality attribute (PQA) data themselves, we enable them to make decisions about which molecules to advance into pre-clinical development more rapidly.

2. How does this collaboration aim to address the challenges of cost reduction and improved productivity in the BioPharma industry?

Interest in continuous processing remains high for its potential to improve biologics production and plant efficiency. The general approach involves running unit operations in a steady or cyclical state for extended periods, avoiding costly stop-start disruptions and downtime. There is a greater need to monitor the process in real-time to ensure that product quality does not deviate from the design space. Rapidly-obtained, actionable analytical data is valuable for more advanced process control, deviation management, and, ultimately, the real-time release of batches.

3. What specific bottlenecks or inefficiencies are prevalent in current bioprocessing practices, and how can they be overcome? Are there any particular areas where cost reduction and productivity improvement can be achieved through strategic interventions?

Manual and labor-intensive processes: Many bioprocessing steps require manual handling, sampling, and analysis, which can be time-consuming and prone to human errors. Robotics and process analytical tools (PAT) helps bioprocess engineers reduce manual intervention, improve accuracy, and exercise tighter control of the manufacturing process.

Lack of real-time monitoring and process understanding: Traditional bioprocessing often relies on offline sampling and product quality analysis. Online monitoring tools, advanced sensors, and data analytics, give immediate feedback to scientists continually monitoring bioprocesses for deviations, and addressing them sooner.

Suboptimal process design and scalability: Inefficient process design and limited scalability limits productivity and increase costs. Quality by design (QbD) principles, advanced modeling techniques, and data-driven optimization helps overcome these challenges. By understanding critical quality attributes (CQAs) and employing process analytical technologies, scaleable and efficient bioprocesses can be designed from the start.

Complex regulatory requirements: Compliance with regulatory guidelines and documentation, while necessary, can introduce inefficiencies in the bioprocessing market. Implementing electronic batch records, automated data management systems, and process analytical technologies streamlines data capture, analysis, and reporting, ensuring regulatory compliance while reducing administrative burden and potential errors.

Limited process integration and data exchange: Non-integrated process steps and data silos hinders efficiency and decision-making. Integrating chromatography systems with analytics software or process control systems enables seamless data exchange and facilitates real-time process optimization.

4. In your white papers on this topic, what key findings or recommendations have emerged that can benefit biopharma companies seeking to enhance profitability and product quality? Are there any notable success stories or case studies you can share?

The white papers demonstrate that by combining the Waters PATROL UPLC Process Analysis System as an at-line PAT tool with the intensified bioprocessing operations of the Sartorius Resolute® BioSMB, we optimize continuous downstream operations to reduce production costs (e.g. resin consumption) and effectively monitor and manage product quality.

Merck Research Labs Biologics & Vaccines Departments have championed and pioneered the idea of integrating analytical technologies into the process and monitoring feedback continuously.[i]

Several CQA measurements, notably Protein A, aggregation, and charge variant, are particularly valuable for linking to and generating clear critical process parameter set points. By combining the PATROL UPLC Process Analysis System as a PAT tool with continuous production approaches (like the Resolute® BioSMB), Merck can monitor CQAs regularly and in near real-time. The findings reveal that implementing next-generation analytics informs and accelerate process decision-making.

5. With the upcoming announcement at IFPAC, could you provide a sneak peek into the new initiative for downstream bioprocessing analytics? What are the main objectives and expected outcomes of this initiative?

When purifying recombinant protein biotherapeutics, near real-time process analytical technologies (PAT) gives process developers and manufacturing engineers the opportunity to make critical and timely decisions for continuously controlling the process within the design space.

Ultimately, this contributes to raising the quality standards of life-saving therapeutics, giving patients greater accessibility to therapeutics, globally, and  potentially alleviate the shortages we’re now seeing with some brand name and generic drug products.

Waters and Sartorius are committed to providing biologics manufacturers with the best tools to ensure efficient manufacturing of safe and effective drug products through the development of integrated production and analytical tools. Our collaboration will continue with those objectives in mind.

6. How do you envision the future of bioprocessing analytics and its impact on the overall efficiency and profitability of the BioPharma industry?

We envision that at-line and in-line bioprocessing analytics will play a very important role in transforming our customer processes from batch to fully connected, highly automated & ultimately continuous bioprocesses. The analytics greatly contribute to process control, predictability (data simulation) and automation, thereby enabling biopharma companies to reduce risks that are hindering the adoption of continuous bioprocessing.

7. Are there any emerging trends or technological advancements that should be on the radar of industry professionals?

Emerging trends and technological advancements in bioprocessing that industry professionals should monitor include:

• continuous bioprocessing
• advanced process analytics (such as PAT and real-time monitoring)
• single-use technologies
• artificial intelligence and machine learning
• advancements in cell and gene therapies
• Industry 4.0 and digitalization, and
• the development of biosensors and point-of-care testing.

8. Could you elaborate on any other initiatives or ongoing projects within Waters Corporation that align with the theme of debottlenecking and process optimization in the BioPharma and life science sectors?

Our initial upstream collaboration focused around the Ambr bioreactors and BioAccord LC-MS. This gave product development groups an improved ability to analyse samples in the clone selection and process development/optimisation phases. The result is that PQA's can now be tracked throughout the upstream process providing greater insight into factors affecting product quality. The parallelization of development flows is also gaining traction in downstream workflows. The on-going collaborative between Waters and Sartorius builds greater understanding of the how downstream process parameters can impact PQA’s.