New scientific developments and analytical techniques in R&D such as Next-Generation Sequencing (NGS) and biotherapeutics (biologics) are bringing new technologies, workflows and data for capture, storage, management, search, analysis and reporting to the lab. Scientists are embracing these new techniques and are creating new entities and generating reams of corresponding data, but organizing and managing this new data can cause problems.

"Core Informatics’ solutions span disciplines and techniques across the R&D value chain, including the new and emerging technologies involved in NGS, biology and biologics."

CASE STUDY 1:
Adding High Throughput Molecular Biology Workflows to a Complex IT Landscape

The Challenge:

A major biopharma company planned to automate its high-throughput molecular biology workflows and data capture. The workflows are complicated, involving many different techniques, instruments, sample types and data.

The company had legacy IT systems in place supporting their antibody production workflow, but the systems could not be adapted to provide automation for the multiple liquid handlers used in the process. Existing spreadsheet-based recording and tracking tools were incapable of handing the sample throughput and data complexity and variability. The company needed a new system to provide capabilities for automating high-throughput molecular biology workflows and managing the supporting data, and to interface with existing tools without complicating the company’s IT ecosystem and data models.

The Core Solution:

The company selected Core Informatics as its partner for two reasons: 1) Core’s proven expertise in biologics, workflow automation and data modeling, and 2) Core’s flexible, configurable and extensible platform, which can cleanly interact with the company’s existing IT infrastructure and companion applications.

The Core team worked with stakeholders from the customer’s lab, business and R&D leadership groups to address all requirements across multiple workflows through configuration, with no custom code.

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CASE STUDY 2:
Adding Next Generation Sequencing Capabilities to Support Precision Medicine Initiatives

The Challenge:

A biopharma company wanted to automate and manage its NGS workflows for greater control and efficiency in its precision medicine initiatives. The company’s current NGS workflow was entirely paper-based, with forms used for sample receipt and vetting, setting up and managing liquid handling events and identifying and tracking samples. This manual approach was incompatible with executing and managing multiple automated workflows.

The Core Solution:

With its extensive expertise in NGS, Core’s team worked with the customer to implement a solution to meet all of the customer’s requirements. Scientists and project managers are now using the Core platform to monitor and evaluate the throughput, effectiveness and quality of sequencing workflows and outcomes. The solution provides actionable information, which helps scientists and business users to identify areas and processes for further extension and enhancement.

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CASE STUDY 3:
Managing Animal Studies with Evolving Requirements

The Challenge:

A major pharma company faced changing requirements to observe and capture different types of data in its in vivo animal studies program. The customer wanted to collect typical single point data analyses from the standard range of treatments and subjects such as body weight, toxicity, pharmacokinetics and bioavailability. In addition, they wanted to conduct and capture animal observations from behavioral studies, including text and other non-numeric descriptors across time-course experiments that might run for weeks or months.

The company’s original data capture and management system was built in-house based on spreadsheets. The system lacked consistency and hampered communication between the researchers and technicians in the multiple departments involved, including animal care, animal handlers and bioanalysis staff.

The Core Solution:

The pharma team configured its Core platform to incorporate these new data types and schedules, and include them in an extended data model. The system also manages and captures output from all downstream testing such as bioanalysis, toxicology, pathology and flow cytometry, and tracks samples and parent/child lineage.

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CASE STUDY 4:
Integrating a New Assay Data Management System with a Legacy Chemical Registry to Speed Testing and Data Capture

The Challenge:

An international pharma company wanted to move beyond spreadsheets and disparate data stores, and selected Core to manage its in vitro and in vivo bioassay systems. The pharma company’s key requirement was for the new assay management system to access and remain in synchronization with the existing small molecule and peptide registry system. The chemical registry was developed in-house and had a unique data model. The system contained the structures and registration numbers of the compounds to test in the assays. The team wanted to ensure that they leveraged their existing investment in the chemical registry, and that users only had to input data once, allowing them to maintain data integrity and process efficiency.

The Core Solution:

Stakeholders from the pharma company worked with the Core team to configure the Core system to match their proprietary bioassay data model. They initially focused on in vivo study management, as it provided the most complex and variable types of data to be captured and managed. The Core system’s flexibility and configurability convinced the customer that the system met their requirements and could be extended to other, simpler in vitro assay types.

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CASE STUDY 5:
Enabling Worldwide Collaboration in a Dispersed Network of CROs for Central Control and Data Analysis

The Challenge:

A clinical stage biopharma company had an extensive array of CROs around the world carrying out multiple aspects of its R&D program, including small molecule synthesis, registration, bioassays and data analysis. The biopharma company was a startup when they first contacted Core Informatics, with no real IT infrastructure or data management capabilities, and they wanted to use a single platform to orchestrate the complete clinical R&D process covering sample, data, request and information capture and flow. The company wanted secure, transparent, central access to all the data generated by the CROs, while each of the CROs should only be able to access and interact with the specific and limited information needed to conduct its work.

The Core Solution:

The biopharma company selected Core Informatics to provide their collaboration infrastructure because of the Core platform’s granular user permissions and scientific capabilities. The customer team achieved their goal of secure worldwide collaboration by leveraging the security and account management capabilities of the Core platform to allow appropriate access by the company’s staff and the various CROs.

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CASE STUDY 6:
Automating Bioprocessing from Experimentation to Manufacturing

The Challenge:

A biopharma company wanted to automate and manage its protein manufacturing and process development from receipt of an initial cell line through process optimization and manufacturing. The company also wanted to replace home-grown legacy applications including cell bank and protein inventories and other related systems

Process development staff wanted tools to monitor online and offline analytical data output and to ensure that appropriate bioreactor samples and their associated data were sent to the next stage in the process – including downstream purification and analysis. During this entire workflow, they needed status and throughput reports as well as the ability to check on the progress of a particular sample.

The Core Solution:

The Core system orchestrates all these workflows, activities and samples, including setting up schedules, printing barcodes and capturing discrete offline data.

New data capture and workflow management tools, built on top of the Core platform, come online seamlessly. Process developers experience minimal disruptions or need for retraining. Moreover, the newly captured data is immediately available for integration with existing information, leading to new insights and smarter, better-informed decision-making.

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