Why Small Molecule Workflows Don’t Work for Biologics

Choosing an Informatics Solution to Support the Complexity of Biologic Development

The Split in Pharma

The pharmaceutical industry is separating into two camps. On one side you will find research and development into traditional small molecule based drugs. On the other side, research is being done in biologics.

In the end, small molecule based drugs and biologics are being created to help make lives better for patients, however, the pathways to that end result are quite different. Both fields of research involve essentially the same procedures: making, characterizing, registering, identifying, testing, capturing, analyzing, and sharing the results of lab work. So, one would think that the workflows to achieve and complete these processes should be quite similar, right? Unfortunately, it’s not that simple. The workflows for biologics are in fact much different than the workflows for small molecule drugs.

Details Surrounding Biologic Therapeutic Development

As always, the devil is in the details, and the details surrounding biologics are much more complex than with small molecules. Consider identification: a small molecule drug typically has a well-defined chemical structure, and this alone can be the basis for novelty checking and registration. But, with a biologic entity, the structure will be much larger and potentially less well defined, making consistent depiction more complex. Other factors such as the sample’s provenance and genealogy will play a crucial role in determining whether the material in hand is novel or is related to a previous sample and how.

Or consider synthesis/production: chemical reactions can be described and captured using a few well-characterized components (starting materials, catalyst, solvent, product), and properties (temperature, pressure, time, amount, yield, purity).

But processes as complex as protein engineering or the construction of an antibody-drug conjugate (ADC), will be sure to overwhelm a legacy small-molecule-based informatics system. Difficulties would result from: the wide range of techniques and disciplines involved; the need to track parent-child lineage and annotations; and the volume and variety of associated data and terminology found in biologics research. With all this considered, it is necessary to use much more sophisticated informatics software within biologics research and development. Therefore, using biologics LIMS software can prove highly beneficial.

An Informatics Platform Providing Biologics Discovery Solutions

Core Informatics’ Biologics Discovery Solution is designed as a modern, holistic informatics platform to address and overcome the challenges discussed above. The Biologics Discovery Solution is comprised of modular apps that support all the important biologics R&D workflows and sample types, and represents industry best practices for biologics data management. This biologics software system enables biopharma organizations to define, collect, analyze, and securely share diverse data within a single, unified, enterprise platform.

The Biologics Discovery Solution is built on the Platform for Science to provide an integrated and adaptable system, including capabilities for data exchange with other systems using RESTful APIs, instrument integration, collaboration tools, and functionality. Because the apps available in the Platform for Science Marketplace are modular and easy to integrate, an organization can pick and choose where to start, focusing on a particular piece of a workflow, or building out a larger enterprise platform. A future blog post will discuss the various apps within this lab informatics system and their application in more detail.

Looking for a Solution to Cover Small Molecule Discovery?

Small molecule drug discovery is still a vitally important part of the pharmaceutical industry and Core Informatics is dedicated to continuing to create solutions for this sector of the industry. The Core Informatics Drug Discovery Solution is designed to handle small molecule drug discovery. Like our Biologics Discovery Solution, the Drug Discovery Solution is also comprised of applications available on the Platform for Science Marketplace. Small molecule drug discovery will be the subject of future blog posts.

Read our tech brief or view our webinar, A Comprehensive Platform for Biologics Discovery.

Platform for Biologics Discovery Webinar