Biopharmaceutical

For the last 30 years, over 300 biotherapeutics related to the biopharmaceutical industry have been approved by the US Food and Drug Administration (FDA) to treat diseases which had very limited or no treatment available including several types of cancers and autoimmune diseases. Their main advantage over conventional treatments relies in the fact that they can be designed and tailored to target key steps in the biomolecular causes of the diseases.

These substances are obtained from biological sources such as microorganisms or plant and animal cells and are composed of larger and more complex molecules than “small molecule drugs” produced by chemical synthesis.

However, their production processes involving living organisms may cause unwanted structural changes in the active molecules which can affect safety and efficiency of the final drug. Thus, due to the structural complexity and sensitivity of biotherapeutics to their manufacturing conditions, their quality must be strictly monitored not only during drug development stages but also during the entire life of the drug product. In AMSbiopharma a team of experienced scientists specialized in the biopharmaceutical area, has developed a multiple attribute approach based on mass spectrometry techniques that covers all aspects included in ICH guideline Q6B “Test procedures and acceptance criteria for biotechnological/biological products”.