How Happy Cells Manufacture New Medications

This article focuses on the technology that ensures quality in the process, and is based on a conversation with Graziella Piras, PhD, Life Science Business Development Director at 908 Devices. Traditional drugs are built from molecules synthesized chemically, combining the active ingredients with other substances that protect the molecules and ensure that they’re delivered to the right part of the body after being swallowed, injected, or otherwise applied. Biotherapeutics, in contrast, are manufactured by living cells; sometimes the cells themselves are the drug. Biosimilars are just biotherapeutics that can replace other drugs, like generic medications. Figure 1: Glass samples The cells are grown in vitro in stainless steel, glass, or plastic vessels known as bioreactors. The bioreactors can be quite small during research and development (see Figure 1), and perhaps hold 2,000 to 20,000 liters in manufacturing. The vessels remain closed in order to prevent contamination, but contain ports to facilitate the sampling and feeding of the cells. Figure 2: Monitoring the cells in a small sample During research, the scientists determine the optimal feeding conditions for the cells to grow and thrive using a culture medium that provides a source of energy and other nutrients. Elements of the medium include glucose, amino acids, vitamins, and other metabolites. Monitoring is crucial during both development and manufacturing in order to maintain ideal conditions (Figure 2). If th...
Source: EMR and HIPAA - Category: Information Technology Authors: Tags: Clinical Health IT Company Healthcare IT 908 Devices Biosimilars Drug Development Graziella Piras Life Sciences Medicine Development Source Type: blogs