Here at Alliance Pharma we specialize in bioanalytical services for both small and large molecules. Each of these molecules present their own unique challenges and obstacles throughout the pharmaceutical development process.
As you likely know, our bioanalytical services are conducted by an experienced team of scientists who can perform rapid method development and implement streamlined processes for method validation and sample analysis. While we use state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS) platforms, the expanding industry wide emphasis on large molecules means that the size and complexity of the molecules continues to increase, often so much so that they are larger than what a conventional mass spectrometers can typically handle. What happens then?
The high m/z range, wide isotope envelope, and multiple charge states associated with many large molecules makes it challenging to use a conventional mass spectrometer. In these cases the use of soft ionization techniques, like electrospray ionization, allow the formation of multiple charge states and can be key to developing suitable methods for complex proteins and oligonucleotides that may otherwise not be quantifiable at low levels. Electrospray ionization has slowly become industry standard, and has established itself as an essential tool supporting large molecule bioanalysis at Alliance Pharma. The ionization process includes high voltage and a liquid stream to ionize the solution and create a charged droplet spray. In essence, this technique protonates or deprotonates the molecular ions, resulting in very little to no fragmentation. Through this, the large molecules can take on more charges, and that measurement is then used with the traditional process of the mass spectrometer.
The sensitivity of an assay is also a substantial concern as the molecular weight goes beyond what can be traditionally measured. At Alliance we often overcome this challenge by using micro or nano flow rates and reduced column dimensions.
Through these techniques and specialized equipment, we can provide the unique bioanalytical support you need for your protein or oligonucleotide. As we see more large molecule therapeutics in pharma pipelines, we continue to adapt to how we characterize and quantify these molecules.
We are proud to also adapt within the industry as we work to create faster drug development, smarter bioanalytical solutions and uncompromised quality as we know what we are testing and measuring benefits more than your company. It benefits the lives of the patients you are working with to increase and prolong their quality of life. That has lasting impacts!
We are ready to talk with you further about how we incorporate these techniques for your pharma and biopharma projects. You can contact us at 610.296.3152 or [email protected] to start the conversation.