Pharmaceutical and biotechnology companies have become leading MS customers. Because they work with human and test animal biological fluids and low-dose drugs, sample preparation takes center stage. Many of these workflows are automated for both sample and standards preparation.
More critical with respect to MS instrument providers are the changes that these “sweet spot” industries are undergoing. Companies are reorganizing, merging, and outsourcing many of their traditional competencies like R&D, particularly the analysis-heavy “bookends” of pharmaceutical development: early-stage discovery and the management of clinical trials. “Their entire business model is evolving, not just the analytical part,” comments PerkinElmer’s Andrew Tyler.
Off-shoring and outsourcing have become a regular part of life science businesses, particularly with the emergence of R&D centers in Asia and central and eastern Europe. Instrument vendors need to embrace global tendencies related to language, corporate culture, and user experience levels.
Nearly every large pharmaceutical company today outsources preclinical testing to contract research organizations (CROs), many of them American. The challenge is that CROs tend to hire technician-level workers to carry out basic assays. Decisions based on test data occur elsewhere.
This presents the obvious challenge of creating interfaces that are intuitive and approachable by lab technicians. It also presses vendors to improve data handling, distribution, and storage since decisions are often made on data generated half a continent away, or even overseas. To meet these challenges, information technology groups at the sponsor and CRO must reach common ground with respect to data accessibility.
The high end of the instrument portfolio is where adoption of accurate mass, high-resolution systems operate for complex research in proteomics, metabolomics, and molecular biology. Biomedical research has emerged as another leading growth area for MS, particularly for systems biology, which unravels labyrinthine biological regulatory pathways involving the expression of genes, proteins, and small molecules, and their chemical communication.
Tandem methods like LC-MS can quantify and characterize putative therapeutic proteins long before a company commits to an expensive development program. During early-stage biological drug discovery, investigators screen hundreds of “clones”—lineages of identical cells—for their capacity to produce proteins in the correct form and commercially meaningful quantities. LC-MS now routinely delivers data on subtle differences in key transformations after a cell expresses a protein, known as “post-translational modifications.”