Biologics Drug Discovery and Development

The term biologic refers to a diverse group of agents that are produced/obtained from biological sources and/or contain biological components. Much like synthetic pharmaceutical agents, biologics are investigated and developed with the aim of targeting and rectifying pathological mechanisms in the human body. However, while synthetic pharmaceuticals mainly affect cellular signaling through the modulation of receptor-ligand interactions, biologics can exert their effects in a myriad of ways through numerous different mechanisms. Biologic agents currently being used for research and therapeutic purposes range from molecules and peptides (e.g., antibodies and hormones), to intact and functional cells (e.g., stem cells), to 3-D structures such as tissues and organs. Because of this diversity, a firm and comprehensive understanding of how biologic agents will behave in different physiological and pathological conditions (e.g., environments, locations, and cell types) is critical to their effective usage and the prevention of side effects.

Key Phases of the Biologics Drug Discovery and Development Process


Target Discovery Focuses on understanding of the disease targets. Approaches used include: genomics, proteomics, knockout and gene silencing methods (CRISPR/Cas9, Talens, RNAi), transgenic animals, crystallography, and bioinformatics.
Analytical Method Development and Testing Involves sample prep and testing of identity, purity, potency, stability and safety.
Assay Development Focuses on chemical, biochemical, ELISA, and cell-based assay methods in the development of biologics.
Production / Manufacturing Small to large scale cGMP manufacturing involving fermentation, purification, and fill finish.
QA / QC Testing Our solution offering for QA/QC testing, including raw material and release testing. Also includes environmental monitoring solutions for cleanroom particulate counting.
Upstream Development Following tech transfer, upstream process development is focused on scaling-up and involves media development (DOE), feed optimization, and leveraging the master cell bank.
Drug Discovery Covers antibody generation/engineering as well as hit and lead identification, validation, and optimization.
Downstream Development Focused on developing bioprocesses for product purification, post translational modification, and release testing.
An Overview of Biologics An overview of what a biologic is, what they're used for, a brief history of biologics development and more.
Preclinical Drug Development Needs the compound in gram scale to study toxicity and pharmacokinetic behavior of the preclinical candidates in depth.