Transitioning to BioAnalysis of Biologics
Industry Insight Jun 15, 2015
The move to large molecules in Pharma offers unparalleled opportunities to improve human health, however with this move comes new challenges for researchers shifting to biologics.
To assist scientists making the transition from small molecules SCIEX have launched BioBA, the first end-to-end solution for bioanalysis of biologics.
To learn more about these challenges and the benefits BioBA provides, we spoke to Joe Fox, Senior Director of Pharma Business at SCIEX.
AB: What are some of the challenges associated with transitioning from small molecule bioanalysis to bioanalysis of biologics?
Joe Fox (JF): Small molecule bioanalysis is a more mature application segment within the pharma/CRO industry and as a result, Bioanalytical scientists have an extant framework to address some of the critical issues in this area. However, the surge in development of large molecule based therapeutics presents new challenges for small molecule LC-MS experts. These scientists are increasingly tasked with the quantitation of large molecule drugs, i.e. biologics bioanalysis of monoclonal antibodies (mAb), antibody drug conjugates (ADC), fusion proteins, and PEGylated proteins in complex biological matrices – all with an evolving set of standards and protocols. The challenges are numerous, but can be broadly classified into three buckets: standardization and robustness in sample preparation strategies, robust and reliable analytical instrumentation that allows scientist to reach requisite LLOQs, and finally, efficient reporting modes that enable scientists to move from sample to answer - faster.
AB: How does the BioBA Solution help scientists overcome these challenges?
JF: The BioBA Solution was built to address some of the key challenges in large molecule bioanalysis and help transition our small molecule experts into large molecule bioanalysis with ease and confidence. The components of the kit were designed in this fashion – and ultimately to add up to a holistic solution. To take each in turn, we introduced sample extraction kits with an easy to follow protocol to alleviate some of the fear in handling large molecules for the first time. We also partnered with our Danaher sister company Beckman to automate the sample preparation process – this eliminates tedious manual sample extraction processes and enhances reproducibility and efficiency. Of course our core offering continues to play a pivotal role as the LC-MS based assay platform delivers sensitive, selective and reliable bioanalytical assays that run with maximum uptime and efficiency. Finally, our GLP compliant MultiQuant software is integrated into the workflow, automating many aspects of integration and reporting that would otherwise require significant operator input.
AB: BioBA is described as being an end-to-end solution; can you explain what is meant by this and how it benefits scientists?
JF: BioBA Solution is a complete package from sample extraction to reporting results, designed to jump-start biologics bioanalysis and accomplish most reliable results in a very short period of time. The BioBA Solution is comprised of the following:
1) High capacity enrichment sample extraction kits and Biomek automation liquid handling workstation – this combination provides bioanalytical scientists with universal and generic approaches for faster method development.
2) QTRAP® 6500 System and Exion LC System match the new sample preparation combination with a robust and reliable LC-MS solution that stands up to harsh analytical conditions while also delivering the aggressive LLOQs required for these compounds. In addition to this, options like MRM3 with the QTRAP platform, and the SelexION device provide selectivity options to help tackle more complex analysis where interferences or background noise can affect LOQ levels.
3) Software tools such as DiscoveryQuant and MultiQuant increase overall productivity by reducing assay method development time, manual data processing and review. MultiQuant Software is simple, easy to use and designed for 21 CFR part-11 compliant applications
4) Pharma iMethods™ are the easiest way to access our repository of proven bioanalytical methods, from sample extraction to reporting results for common biosimilars in development. Pharma iMethods reduce the need for method development, leading to significant cost and time savings.
The integrated solution is designed to reduce complex assay development and help achieve accurate and reproducible results faster than ever.
AB: How does SCIEX support scientists using BioBA?
JF: We’re fortunate to have a large, global, applications and support team with deep and varied expertise in large molecule bioanalysis. The professional and highly-trained team can develop and optimize bioanalytical methods according to the customer requirements. The partnership and consultation model together with the new BioBA Solution make the process more efficient and are key to success. In addition we have deployed rich eLearning modules that offer sophisticated guidance, as well as online learning tools to improve knowledge in large molecule bioanalysis. From in-person support, to phone, to on-line – our customers have an array of support options to ensure they are moving from sample to answer – faster.