Lonza Biologics is part of Swiss life science giant, Lonza and as a contract biologics development organization (CDO), it needs to stay extremely competitive. This is achieved by providing a consistently high quality service to their customers while keeping overheads as low as possible and optimizing the efficiency of working practices. A ‘right first time’ approach underpins all its activities.

Early adopter

Continuous business improvement is a central tenet to Lonza Biologics maintaining its position as one of the world’s top CDOs. Moving away from paper-based processes offered an ideal opportunity to affect the key drivers of their business – increasing both quality and efficiency and reducing overheads. By proactively moving to an electronic system, Lonza Biologics considered it could also improve its competiveness by enhancing real time process insight and providing a foundation for knowledge management. Lonza Biologics has since become one of the first CDOs in the biologics space to take this approach. Its vision goes beyond simply replacing paper and conducting retrospective process analysis.

“IDBS provides the best solution for the development of biologics and bioprocesses.”

 

“We wanted to capture everything electronically and create a knowledge source of context-rich data which was more meaningful, searchable and reusable. Our vision was to employ a solution to improve data quality and accuracy, limit transcription errors and prevent–rather than merely detect–potentially costly deviations within our work. Our goals were ambitious because our ultimate aim was to optimize operational excellence within our operations and also across the entire business,” said Marc Smith, Project Team Leader of Knowledge Management Systems.

Enriching customer engagements

Collaborating closely with its customers is an essential element of Lonza Biologics’ business. It has to understand and navigate demanding multi-step- processes from early clinical development to full scale manufacturing in order to effectively serve its customers. It was becoming clear customers had growing expectations around data availability and rapid turnaround of data analysis and, crucially, Lonza Biologics realized these would become increasingly difficult to satisfy using existing paper processes and siloed systems.

“We knew an electronic system could save us time, reduce errors and increase collaborations. We were also eager to anticipate our customers’ demands for quality, speed and cooperative working. Finding a solution provider that would understand our business and help to enrich our customers’ experience in working with us was also a top priority,” said Smith.

Biologics development needs flexibility

Lonza Biologics wanted to create a solid electronic framework for its scientific and process data. It adopted a domain-centric approach to vendor selection with in-depth assessment and measurement of each vendor’s capabilities to support the development of biologics and bioprocesses. A number of suppliers were interviewed and the three shortlisted were invited to demonstrate their products and attend a roundtable discussion.

“IDBS answered our questions with confidence and authority. Its Bioprocess Execution System, based on E-WorkBook is well suited to the biologics development environment because its flexibility enables design ‘on the fly’. Other vendors have tried to accommodate variation within otherwise ‘fixed’ workflows but these seem overly rigid and don’t feel as clean or slick as IDBS’ approach. Having worked with IDBS for nearly three years now, I firmly believe IDBS provides the best solution for the development of biologics and bioprocesses,” said Smith.

The single most important step

Smith considers the single most important step to be the effective understanding of requirements. He believes it takes great skill to capture the actual way scientists work and then translate that into a system which supports their activities while helping them to improve their research and understanding. The key, he says, is to educate those scientists tasked with collating and authoring requirements.

IDBS’ experience and expertise in the biologics domain made them ideally placed to deliver this project. Working with IDBS, Lonza Biologics has deployed a portfolio of electronic workflows to replicate processes which were defined internally by standard operating procedures (SOPs). SOPs are a key differentiator for Lonza Biologics and are widely used to drive added value.  The IDBS solution complements Lonza Biologics’ existing SOPs with workflows which offer the scientists a degree of in-built flexibility without compromising process control where it’s needed. Quality Assurance (QA) is enhanced by drastically reducing error margins and flagging deviations – reviewers don’t have to go looking for errors and deviations as they are reported automatically.

The biggest challenge

“Our scientists had to keep working on customer projects, so we needed to grab every possible opportunity to spend time with them. Their early input was crucial to the success of the implementation as we needed to establish those all-important requirements. Without those we couldn’t deploy meaningful workflows that could be tested effectively. We ended up adopting an ‘agile’ approach as traditional linear style project management techniques were too limiting and time consuming,” said Smith.

Lonza Biologics still dedicates considerable effort to continuous training and supports users with adoption workshops, in-laboratory coaching, telephone support in business hours, bi-weekly ‘walk-in clinics’, online ‘tips and tricks’ and a helpdesk to electronically record incidents. A team of scientists act as subject matters experts and are available to help others within their labs.

A new reality

Lonza Biologics’ deployment of the Bioprocess Execution System has helped to integrate and optimize their bioprocess activities, managing the complete laboratory-to-report lifecycle within one single system. The deployment covers workflows across process development and analytical services and supports 300 users across four global sites.

“Capturing and manipulating 10,000 data points is now so much easier than manual processes using paper and spreadsheets. People at the bench really like using it. If they conduct a bioreactor run, all the previous work is referenced automatically and when they finish the experiment, they sign off and they’re free to move on to the next bit of science - which is what really interests them. A few months ago we were recording 20 assays per month now we’re already recording 400 assays in the same period and this continues to steadily increase, as has overall quality,” said Smith.

The final chapter

The most impactful time savings Lonza Biologics expects is within the reporting phase of projects.  Reports which previously took weeks – and in a few cases, months – to complete can now be reduced to days. This is because the results, which tend to be spread across many experiments, can be aggregated and formatted automatically. The elapsed time for the report to be produced is therefore significantly reduced.

 

“Its early days but already the results we’re achieving are amazing. And there’s still so much more we’re expecting it to do.”

 

This is a key differentiator between IDBS’ solution and other data management systems such as basic ‘sticker book’ or ‘paper on glass’ electronic laboratory notebooks (ELNs). Structured data (for example, experimental conditions and results such as purity and potency measurements) is managed alongside the scientific narrative, giving accessible and searchable data which can be aggregated, analyzed and reported on in ways  not possible in document-centric systems.

A further differentiator is that the capture of the ‘structured’ data can also be controlled and directed, giving the opportunity to embed and control the process of the experiment execution. It is a solution to support, manage and execute bioprocess workflows, not merely a tool limited to paper replacement or process insight.

Selling the concept internally

Smith believes ‘selling’ the concept of new IT solutions is about recognizing the different benefits everyone across the organization gets. Technicians still have to enter some of the data manually but it is far easier to find and there are significantly fewer mistakes. Those people involved in data analysis activities now have access to data in a structured format which makes their analyses more productive and insightful. Finally, managers can quickly see how a project is performing as the relevant information is now easily accessible through a dashboard.

“In the future if, during a meeting, a customer wants to see how their cell line is performing, we will be able to show them. We’re keen to start linking systems and share data with our customers going forward. Looking back, this project has been much more about information management–sharing what’s been in people’s heads–rather than knowledge management, which still remains with scientists. It’s early days but already the results we’re achieving are amazing. And there’s still so much more we’re expecting it to do,” says Smith.