Case Studies

Driving Customer Success


Pfizer Builds on the Genedata Biopharma E2E Workflow Platform

 

 

»Pfizer is pleased to have gained full access to this system for antibody discovery and protein engineering, which is now an integral part of Pfizer’s large-molecule discovery engine«

Dr. Will Somers, VP Global Biotherapeutic Technologies, Pfizer

 

 

Background & Challenges

Pfizer, the world’s largest pharmaceutical company, is a research-based organization with significant R&D investment. Key research areas include inflammation and immunology, internal medicine, oncology, rare disease, and vaccines. Biotherapeutic discovery and development within Pfizer is centralized in the Biomedicine Design and Biotherapeutic PharmSci departments.

With R&D teams spread across the globe, vast amounts of data were being collected in silos, making it difficult for teams to share information. This impeded collaboration and led to process inefficiencies. The challenge Pfizer faced was the alignment of workflows and the centralization of data for more than 200 Pfizer scientists located at 6 sites around the world.

After an aborted earlier attempt with a develop-as-you-go approach, Pfizer decided to evaluate the market in search of a commercial enterprise data management system for their large-molecule R&D groups. The desired system would need to act as a backbone platform and central repository for Pfizer’s biological R&D workflows and include tools able to capture specific instrumental data, workflows, analyses, and each group's unique contribution to the overall biological drug discovery process at Pfizer.

Solution: Genedata Biologics

Digitalization Requirements in Biopharma R&D:
The identification of large-molecule therapeutics, such as monoclonal antibodies (above), is based on sophisticated R&D technologies that produce vast amounts of data that need to be captured, processed, stored, analyzed, and interpreted in order to identify suitable drug candidates. Biopharma R&D organizations, such as Pfizer, require a workflow management platform tailored to biopharma requirements to streamline the full R&D process and identify the next-generation of biopharmaceutical drugs.

After conducting a thorough market evaluation to identify an off-the-shelf enterprise system for large-molecule discovery, Pfizer decided to implement Genedata Biologics® as their central repository for their biologics discovery data, including screening, molecular biology, engineering, expression, purification, and analytics. Since the platform works out of the box and includes unique and comprehensive built-in business logic for all major discovery technologies, such as phage and yeast display, hybridoma, or B-cell-based approaches, Pfizer was able to get up and running quickly. In addition, the platform’s open architecture made it possible for Pfizer to integrate it into their existing R&D and IT environment and to develop highly integrated custom tools on top.

“One of the reasons we chose Genedata Biologics was the platform’s process coverage. We required that the full diversity of Pfizer’s large-molecule processes and technologies be supported by one integrated system,” said Dr. Sergio Rotstein, Director, Research Business Technology, Pfizer.

The overarching reason Pfizer chose the Genedata platform, however, was its ability to serve as a central data backbone and application environment upon which they could build tools to flexibly address Pfizer-specific requirements and to drive innovation using the system’s ability to onboard specialized R&D groups, which employ novel and proprietary discovery technologies. 

Efficiency Gains & Cost Savings

As a commercial off-the-shelf (COTS) product, Genedata Biologics went into operation for the first R&D user groups in just a few weeks, followed by adoption across the entire Pfizer Biomedicine Design discovery organization. The figures speak for themselves: after only four years, the system is now used by more than 250 people in 15 groups located at 6 Pfizer R&D sites around the globe and supports 200+ distinct discovery projects, including more than 900,000 clones, 28,000 lead molecules, 900 cell lines, and tens of thousands of protein batches and their respective analytics and QC results.

For all these groups, Genedata Biologics enabled a high-throughput protein production workflow that was instrumental in dramatically increasing project throughput, with Pfizer reporting an increase, by a factor of as much as 10, in antibodies converted to full IgG per project. Furthermore, the system has helped to improve quality of results by eliminating errors resulting from passing spreadsheets and other ad hoc data exchange. Finally, the system has helped to standardize workflows and requests and allows specialized groups to work and operate more efficiently in a division-of-labor organization.

“Pfizer is pleased to have gained full access to this system for antibody discovery and protein engineering, which is now an integral part of Pfizer’s large-molecule discovery engine,” said Dr. Will Somers, VP Global Biotherapeutic Technologies, Pfizer.

Having central access to relevant R&D information has revolutionized how Pfizer discovery groups work today. In the past, information was scattered across groups and geographies and people needed to spend an inordinate amount of time trying to find and interpret key data. Now, every group has immediate access to critical information, such as protein and DNA sequences and measures of developability and manufacturability, which enables informed decision-making and saves tremendous time and, ultimately, money along the R&D process.

Having a shared central system also means that creation of manual batch reports is a thing of the past for many research groups. Since all the data is registered into the system during daily operations, information on every lead is updated in real-time after each step along the R&D workflow. This means collected data can be tracked and verified all the way back to the beginning of the R&D workflow, providing a crucial historical record.

Building on a Solid Foundation

Besides the immediate functional benefits witnessed after implementing Genedata Biologics, Pfizer chose the system as their large-molecule R&D data backbone for infrastructural and architectural reasons. Pfizer wanted simplified  and harmonized R&D operations. At the same time, they wanted a platform that could flexibly address Pfizer-specific requirements, such as Pfizer-proprietary antibody molecule formats (e.g., bispecific antibodies), and that was  extendible, so that Pfizer’s informatics and IT teams could build new functionalities on top of it. The flexibility and openness of the Genedata system was a key criterion behind Pfizer’s choice. “Genedata Biologics’ flexibility allows Pfizer to configure the system to address both proprietary discovery processes as well as Pfizer-specific business processes and nomenclature,” said Dr. Sergio Rotstein, Director, Research Business Technology, Pfizer. 

Increasing automation & throughput: The direct integration of the Genedata platform with Pfizer's automation equipment and laboratory robotics has enabled Pfizer to dramatically increase throughput of the large-molecule R&D process, such as sample handling and testing. The Genedata platform allows users to automatically control and manage pipetting and sample handling by liquid handling robotics stations and assay readers, enabling true highthroughput biopharma screening, engineering, and production processes.

Genedata Biologics is an open system based on an industry-standard three-tier architecture. Pfizer can easily extend the system to support future changes in technology or functionality – which is what clearly differentiates Genedata Biologics from many other options. The initial deployment, as well as ongoing extensions and adjustments, demonstrate a maximum ability for configuration and customization.

“We had a vision when we brought in Genedata and it quickly became clear that Genedata provides an excellent structure to the data and a great foundation to build upon. Antibody drug discovery is an extremely dynamic field, and our teams constantly bring in new science and innovative technologies that require custom workflows, additional metadata, or integration with robotics and automation equipment. By having the Genedata enterprise platform as our central data backbone, we can build our own in-house solutions around it and keep all the information secure, stable, and accessible in one central place,” said Dr. Joel Bard, Associate Research Fellow, BioMedicine Design, Pfizer.

Another key decision criterion behind adoption was the system’s data interoperability and system integration  capabilities. Even in a complex, multivendor environment, Genedata Biologics can seamlessly interact with diverse instruments and IT environments. Comprehensive Application Programming Interfaces (APIs), based on RESTful web services, enable multifaceted — yet easy to maintain — integrations.

Finally, information security and IP protection capabilities were central to Pfizer's decision to move forward with Genedata. The system’s fine-grained user and access control, together with its easy integration with Pfizer’s corporate authentication systems, were additional reasons behind their choice.

Expanding Scope: Genedata Bioprocess

Three years after the deployment of Genedata Biologics, Pfizer decided to expand beyond discovery and implemented Genedata Bioprocess® to support their large-molecule pharmaceutical development.

"After conducting a pilot project to determine if Genedata Bioprocess had the potential to meet our requirements, we decided to move forward with its implementation,” said Dr. Sergio Rotstein, Director, Research Business Technology, Pfizer. The integration of Genedata Bioprocess with Pfizer’s existing Genedata Biologics platform has created a centralized, shared data repository that can be accessed by both research and development units. Improved data tracking and analysis via integrated data collection and enhanced data association has helped Pfizer to streamline data-focused biopharma development processes.

Pfizer decided to operate the Genedata platforms in one instance to facilitate maintenance and  integration. As such, fundamental data for development candidates can now be handed over seamlessly from the Biomedicine Design discovery group to the cell line development team in charge of developing high-titer, stably expression cell lines.

Future

The Genedata platform has become a vital part of Pfizer’s R&D organization and is used at every stage of their large-molecule research operations. Pfizer is now looking to further expand the platform to new fields and applications and usage of the platform is being extended in two directions.

First, Pfizer is working towards expansion of the use of Genedata Biologics for research on novel therapeutic modalities and further downstream in the development process.

Second, Pfizer has started to use Genedata Biologics as the foundation for artificial intelligence (AI) and machine learning approaches to lead optimization. The availability of all experimental assay and analytics data for all molecules and samples, including historical data, in a highly structured database, enables Pfizer to systematically mine data across projects. By applying deep learning algorithms, Pfizer can identify correlations between drug-like properties and molecule characterization data. For example, machine learning algorithms can make predictions about the risk profile of any given drug candidate.

“We have come a long way since we decided to deploy Genedata Biologics at Pfizer. We are committed to continue working closely with Genedata and we are very pleased with the knowledgeable and engaged support we get from the Genedata team,” said Dr. Joel Bard, Associate Research Fellow, BioMedicine Design, Pfizer. “Now that we have a central data backbone in place where all information can be accessed and shared, our R&D groups can spend their time on critical scientific tasks, instead of manual data reporting and management."

 

 

 


 

 

MorphoSys Accelerates Antibody R&D

 

 

» Genedata Biologics saves valuable research time and money«

Dr. Markus Enzelberger, Chief Scientific Officer, MorphoSys

 

 

Background & Challenges

MorphoSys is a late-stage biopharmaceutical company devoted to the development of innovative and differentiated therapies for patients suffering from serious diseases. Based on its proprietary technology platforms and leadership in the field of therapeutic antibodies, MorphoSys, together with its partners, has participated in the development of more than 100 therapeutic product candidates currently in R&D. The company has one of the broadest pipelines in the biotechnology industry, including unique approaches for patients with conditions such as cancer, Alzheimer’s disease, infectious diseases, cardiovascular dysfunction, and inflammation.

The MorphoSys implementation of Genedata Biologics® as their end-to-end workflow platform has resulted in a significant increase of efficiency across all R&D functions, including library generation, screening and selection, molecular biology, antibody screening, protein engineering, expression, purification, and analytics.

The MorphoSys pipeline is based on a combination of strong business partnerships and proprietary development activities. MorphoSys has partnered with major biopharmaceutical companies including Astellas, Bayer, Merck & Co., Boehringer Ingelheim, Novartis, Janssen, Pfizer, Daiichi Sankyo, F. Hoffmann-La Roche, and Shionogi. Using MorphoSys’ proprietary synthetic antibody libraries and their phage display screening technologies HuCAL, Ylanthia and Slonomics,  MorphoSys enables faster, more flexible and, ultimately, better-quality access to drug candidates.

The rapid growth of MorphoSys has led to a significant increase in molecule and sample throughput, which has made it challenging to capture, process, and interpret the huge amount of resulting R&D data. “The scale and throughput of our operations necessitated the use of an enterprise workflow platform to manage and streamline the growing number of our discovery programs,” said Dr. Markus Enzelberger, Chief Scientific Officer at MorphoSys.

To cope with this data avalanche, MorphoSys decided to implement a corporate workflow platform as a “data backbone” to capture and process all data generated by their R&D programs. The goal of the new system was to make MorphoSys’ sophisticated R&D processes more efficient and to facilitate handovers between various R&D teams and functions, including screening, molecular biology, engineering, expression, purification and analytics. The new system also needed to be able to handle the increasing amount of data and samples produced by external partners, such as CROs, which had to be integrated into MorphoSys’ R&D process.

Flexibility and scalability of the new solution was of utmost importance. “Our biopharma R&D operations required an integrated and scalable informatics infrastructure that can be tailored to support our biologics discovery processes,” continued Dr. Enzelberger. MorphoSys required a solution that could be flexibly adapted to future R&D processes.

Solution

After a formal selection process, MorphoSys decided to implement Genedata Biologics® as their new enterprise workflow platform,  which they internally refer to as “Ybase”. A key reason for this decision was the fact that Genedata Biologics is the only turn-key system available in the antibody R&D space. This allowed for rapid deployment and gave MorphoSys full process coverage right from the start.

“Genedata Biologics provides the flexibility needed to support our proprietary antibody discovery processes and technology portfolio,” noted Dr. Enzelberger. "More importantly, Genedata Biologics provides all these functionalities out-of-the-box, which saves valuable research time and money,” he added.

Genedata Biologics was deployed as MorphoSys’ end-to-end workflow platform across all discovery and development units. As part of the deployment project, the platform was integrated with all relevant laboratory equipment and IT systems, ensuring smooth and efficient data exchange between different systems and groups.

Today, Genedata Biologics is MorphoSys’ enterprise workflow system for 150 users, including scientists, program managers, engineers, technicians, IT, and management. In addition, the system has become the central “mission-control center” for all their partnered and proprietary development programs.

High-level overview of one of the MorphoSys R&D workflows. Due to the flexibility of the Genedata Biologics® platform, MorphoSys’ proprietary technologies are fully supported. Shown here is MorphoSys’ Ylanthia technology, comprised of over 100 billion distinct, fully human antibodies, which translates into a huge amount of structurally diverse entities that need to be systematically screened for therapeutic candidates. This approach simultaneously pre-selects based on expression levels, increased shelf life, serum stability, and solubility, as well as improved aggregation behavior. Resulting candidates from the Ylanthia library screens are then optimized with unprecedented speed and flexibility using MorphoSys’ proprietary Slonomics technology.

Efficiency Gains & Cost Savings

Using Genedata Biologics as their central workflow platform, the MorphoSys R&D teams can now access all project information in real time. The ability to immediately see the status of any project at any time allows for more informed and rapid decision-making at all levels – from corporate leaders to scientists, engineers, and technical staff.

This access to R&D information has transformed how MorphoSys operates today. In dedicated project dashboards, all teams can look up project information such as molecule characteristics (e.g., sequences, assay data, analytics data), as well as operational key performance indicators (KPIs) that help them more effectively make decisions. Using a shared workflow platform also encourages all collaborators to review, comment on, and use the same data and planning information. This improves accuracy and quality of critical project data, and effectively cuts down on redundancies and inconsistencies.

Genedata Biologics® has become MorphoSys’ central “mission-control center” for all R&D programs. All R&D teams have immediate access to comprehensive status information on all projects at any time, which allows for effective decision-making at all levels. At MorphoSys, 150 users, including scientists, program managers, engineers, technicians, IT, and management benefit on a daily basis from the shared platform.

As an additional plus, teams no longer need to create manual reports, as reporting is now the result of day-to-day operations. After each step in the R&D workflow, such as for an antibody optimization campaign, the responsible scientists register all relevant data (e.g., binding, activity data) and the drug candidate information is automatically updated for the next step in the workflow. Furthermore, all contextual and collaborative data are tracked and can be verified, providing a vital history of all drug candidates and samples.

The biggest impact, however, has been on the agility of the R&D teams. MorphoSys recently surveyed its R&D teams and found that time spent on administrative tasks had been reduced by about 25% – and for some standard tasks by even more than 50%. This has freed up valuable time for the R&D teams to focus on critical scientific tasks, such as analyzing a candidate’s efficacy and safety profile along with developability and manufacturability data, to make earlier informed decisions on the best drug candidates to move forward. Genedata Biologics helps MorphoSys’ scientists to spend their time on science rather than on cumbersome manual IT housekeeping tasks, reporting, or data management.

By standardizing and automating the underlying workflows, R&D processes have become more efficient and robust, which in turn has enabled a scale-up of MorphoSys’ R&D operations. Plus the speed and accuracy of the drug discovery and development process has improved.

Future

Morphosys has integrated their high-throughput robotic platforms to directly interact with Genedata Biologics®. This enables full automation of the overall process for antibody library screening, including isolate tracking, from automated picking of bacterial colonies, primary screening of thousands of single clones in robust 96/384 well assays (ELISA, FACS, Biacore, etc.), fully automated transfer of a pre-defined selection of positive clones for further validation, cross-assay hit selection, including cross-reactivity and quality control of positive clones, and automating the iterative affinity maturation processes. Open interfaces enable a transparent integration via APIs (RESTful webservices).

MorphoSys is now well prepared to address new large-molecule R&D requirements as they benefit from having an evolving system, with multiple upgrades per year.  “We are pleased to see the steady and continuous evolution of the Genedata Biologics platform and how it addresses our constantly emerging new technology and workflow requirements,” said Dr. Enzelberger.

Since deployment of the platform, MorphoSys has come to rely on this ability of Genedata Biologics to adapt to new R&D processes and objectives, such as MorphoSys’ new Ylanthia and Slonomics library technologies. Furthermore, as an open and flexible system, Genedata Biologics is future-proof as it can quickly and cost-effectively be integrated with any novel laboratory instrument or robotics equipment.

Finally, MorphoSys values the ongoing support Genedata provides. “We appreciate the collaborative approach with Genedata, and their unique expertise in biopharma discovery and process optimization,” continued Dr. Enzelberger. With offices around the globe, MorphoSys is pleased to have local support available when and where they need it.

Dr. Enzelberger summarized, “We made a decision early on to use Genedata Biologics as MorphoSys’ workflow backbone to accelerate our drug discovery efforts and have watched as Genedata Biologics has become the global industry standard for biopharma discovery organizations.”

Images: © MorphoSys / Genedata