Special Considerations for Research Using Biologics Workflows
Small Molecule Drug Discovery Workflows versus Biologics Workflows
OK, Trivia buffs: who first coined the phrase “small is beautiful?” You get an honorable mention if you answered British economist E.F. Schumacher, but the correct answer is Austrian philosopher and economist Dr. Leopold Kohr, who was one of Schumacher’s teachers.
For therapeutic drugs, small has certainly been beautiful, with the vast majority of marketed drugs being described as “small molecules,” i.e., molecular weight < 900 Daltons (Aspirin is 180 Daltons). Though these drugs have been profitable for large companies, they fulfill the philosophy espoused by small is beautiful – improving life for the common man. There have been long-standing exceptions, of course, with insulin weighing in at 5807 Daltons, and erythropoietin (EPO) at 30-34K Daltons, but these biologic entities are better described as large molecules.
A small set of stable and well characterized parameters easily describes typical small molecule research workflows (e.g. synthesize, register, inventory, test, analyze, repeat). But this is too limited and inflexible to tackle the volume, variability, and velocity of the data and datatypes needed to manage and capture the output from complex, multi-disciplinary biologics research activities or production runs.
Special Considerations for Biologics Drug Discovery
While small molecule drugs continue to be developed for treating and curing diseases, there is increasing interest and focus on biologics R&D, with seven out of eight of the top selling drugs worldwide in 2014 being biologics. We discussed the substantial differences between small molecule and biologic drugs, particularly in relation to the processes used to create them, and the methods used to characterize, identify and track them. These differences in turn pose challenges for any LIMS systems or informatics tools being designed to support biologics research and production workflows.
Specific biologics-focused informatics tools are necessary for optimal outcomes. Requirements of these tools include:
- Maintaining stable and repeatable processes
- Consistently tracking the lineage and genealogy of the biologic materials
- Characterizing as much of their structure as possible
Efficiencies will be realized when biologics data can be consistently captured, analyzed, and reported across the discovery continuum and informatics system.
Core Informatics’ Biologics Discovery Solution
This is where Core Informatics’ Biologics Discovery Solution comes in. Its design embodies industry best practices for data management in all facets of biologics R&D and production workflows. It is built in on Core’s Platform for Science to provide an integrated and adaptable solution that can also exchange data with other systems using RESTful APIs (Application programming Interfaces).
Core’s Biologics Discovery Solution is composed of modular apps, available through the Core’s Platform for Science Marketplace, that support the commonly encountered biologics workflows. Labs can use one or two apps to address a specific process, or an organization can integrate several apps together to provide an enterprise-wide platform covering an end-to-end workflow.
The Biologics Discovery Solution provides four key sets of capabilities:
- Biological Sample Registration
- High Throughput Screening (HTS)
- High Throughput Library Generation
- Sample Inventory and Management
So deep in the world of molecules, where small is beautiful, and big may be complex and messy, but equally gorgeous, sits Core Informatics’ Biology Discovery Solution. This informatics system is a solution that overcomes complexity and diversity to deliver a modern, modular enterprise platform built to meet the needs of researchers and business leaders across all phases of biologics discovery and development.
Contact Core Informatics today to read a tech brief on how our Biologics Discovery Solution can help you.