Under the Microscope: Fredrik Sundberg, GE Healthcare

As a company whose expertise includes medical imaging and information technologies, performance improvement and biopharmaceutical manufacturing, GE Healthcare is well placed to support drug discovery innovation and productivity. With the Pharma industry moving away from blockbuster discoveries and focusing more on orphan drugs and rare diseases in the hopes of achieving medical breakthroughs with wider implications, GE Healthcare sees this impacting on the development of new drugs. “It will require faster, more flexible development capabilities and smaller-scale batch production operations,” Sundberg surmises. “It will be of key importance to try to decrease time-to-market (TTM) to get a return of investment as quickly as possible.”

“The global Pharma industry is currently looking for alternatives to improve drug discovery efficiency,” Sundberg continues. “Attempts to build a long-term sustainable business include consolidation and outsourcing to emerging markets, but also the introduction of new predictive technologies earlier in the process.” Other trends that Sundberg believes are of growing interest are the use of functional cell-based assays and increasing attempts to frontload toxicity testing with better tools for prediction. “GE’s cardiomyocyte cells have attributes analogous to their counterparts in the human body, making them more relevant for the accurate prediction of pharmacological characteristics of drug candidates,” Sundberg says, “And the use of cellular assay products together with the automated IN Cell Analyzer system is an example of innovation that we are making available to the drug discovery and development community to support cutting edge research and development, and ultimately improve healthcare.”

“GE can help drug developers meet regulatory demands,” Sundberg reassures. “Several of today’s FDA approved protein-based drugs have been developed using our scalable chromatography equipment and media. Meeting current regulatory requirements for protein analytics and purification systems can be a very timeconsuming and costly exercise, so we offer comprehensive validation support solutions including documentation and on-site performance by qualified engineers, saving several months labour in a project and enabling faster time-to-start.”

Many global pharmaceutical and biopharmaceutical companies are increasingly outsourcing early-stage drug discovery to emerging markets such as India and China. “India is a force to be reckoned with in contract manufacturing,” Sundberg admits. “Contract Research Organisation activities in discovery and clinical development are also growing quickly and big Pharma R&D centres are moving towards growing economies. Investing in these emerging markets makes sense. GE currently has local stateof- the-art research centres and local sales organisations to better address growing market opportunities.”

GE Healthcare believes that the industry is currently undergoing a biologics transformation. In an attempt to minimise drug development risk, the pharmaceutical industry is looking for biomarkers early on, or even companion diagnostics. However, most protein therapeutic drugs elicit anti-drug antibody (ADA) responses against the product, which can lead to potentially serious side effects. “Immogenicity testing is a key regulatory and technical concern,” Sundberg admits. “In order to minimise risks and better monitor immunogenicity, we provide an innovative label-free surface plasmon resonance biosensor technology for real-time serum antibody detection and characterisation, with a unique ability to detect even ‘low-affinity’ serum antibodies, missed by classical end-point assays.

Biophysical label-free approaches have largely been developed in terms of information content and data quality rather than sample throughput. “These systems are primarily being used in drug discovery to characterise compounds downstream of primary HTS, for example in hit-to-lead and lead optimisation studies,” Sundberg says. “The ability to detect the small size, combined with frequently low targetbinding affinities, makes these biophysical analysis methods particularly useful. The recently developed Biacore systems with specific features (e.g. a parallel analysis array-format) enable this type of biophysical approach to be used as a powerful new primary screening option in fragment-based drug discovery.”

“Combining Biacore and MicroCal systems has shown to be very effective in supporting research by linking structureto- function,” Sundberg reveals. “Data from two orthogonal techniques are often needed for confirmation of results. It provides more information faster enabling scientists to make better candidate selection early. The systems fit very well together with complementary and unique data for understanding binding events and protein stability. The new label-free biophysical approach provides critical data and enables significant productivity improvements.”

About the Author

Fredrik Sundberg is Director of GE Healthcare Life Sciences, Global Pharma for the industrial sector, Fredrik is responsible for working with the global biopharma and Pharma industry. He is working to improve current workflows and expand the application of label free analysis throughout discovery and development, in-process and quality control. He advises on R&D projects and has specialist knowledge in the area of regulatory compliance, validation support and frequently provides GxP (GLP, GCP, GMP) training to the industry. He has conducted several pharmaceutical development projects, completed validation studies for a variety of analytical instruments and process equipment used for vaccine and drug development. Over the years, he has produced more than 100 IQ/OQ/PQ qualifications for different companies worldwide.