For the last 30 years, over 300 biotherapeutics 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 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”.
AMSbiopharma contract laboratory services offer a range of capabilities to become a reliable biopharmaceutical industry partner. As a business unit part of the AMSlab team, with more than 10 years of experience, we provide the resources, expertise and know-how on Mass Spectrometry technique and many different applications to help you navigate complex bio/pharmaceutical projects.
AMSbiopharma offers a full catalogue of analytical services focused on structural characterization for recombinant proteins and monoclonal antibodies, for both biotech industry/manufacturing sites and for investigational biopharmaceutical centers.
Additionally, throughout our workteam for pharma industry, AMSbiopharma offers customers comprehensive studies for small molecules (quantification, indentification and characterization).
Our Analytical Services for biopharmaceuticals
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In most cases, the initial consultation will be sufficient. In more complicated cases, a second, follow-up consultation may be necessary. You can contact our center at any time and ask your questions. Our professional support representative will answer your questions with great pleasure.