If you watch TV and know anything about pharmaceutical drugs, you know biologics have arrived. Sufferers of rheumatoid arthritis (among other conditions) see advertisements for Humira, Remicade, and Enbrel – all top-selling biologics. Rituxan, Avastin, and Herceptin are best sellers in cancer treatment. Diabetes, Alzheimers, HIV/AIDS, and other major diseases have biologic treatments now. In fact, eight of the Top 10 best-selling drugs in 2015 were biologics.
Estimates for the global biologics market size vary, but it can be expected to grow nearly 11 percent annually, reaching $386.7 billion by 2019. By 2020, biologics could account for more than half of Top 100 pharmaceutical sales.
Another indicator of the lasting power of biologics is investment in biosimilars – which is estimated to reach $35 billion by 2020, up from just $1.3 billion in 2013. Biosimilars are follow-on drugs to biologics whose patents are expiring. Unlike generics of chemical drugs, biosimilars are not exactly interchangeable but may be substituted if they have “no clinically meaningful differences in terms of safety and effectiveness from the reference product,” according to the FDA.
Biologics: Increasingly Popular, but Challenging
Pharmaceutical companies are embracing biologics, but they are costly and challenging to make. Biologics are made up of living matter (such as human cells, bacteria, and yeast) and can be comprised of up to a million atoms, compared to chemical medicines that can have less than 100 atoms http://phrma.org/what-are-biologic-medicines . Unlike chemical drugs - which offer one molecule per one target - biologics are often multi-targeted to treat a collection of conditions (For example, Humira treats moderate to severe RA, but also ulcerative colitis, Chrohn’s disease, and plaque psoriasis.)
For these reasons, biologics can take up to 18 months just to produce (not counting discovery and development). They have been compared to manufacturing an airplane of 6 million components, while traditional small-molecule drugs are more like assembling a bicycle of 150 pieces. Another comparative data point: there may be 40 to 50 critical steps in the manufacturing process for a chemical drug, but for biologics that could run to 250 or more.
Given that biologics may offer advantages over small molecule drugs, pharmaceutical and biotech companies are looking to find ways to optimize the discovery, development, and manufacturing processes involved. Often this means multi-department and external collaboration and work of a distributed nature.
Science-based informatics solutions can have an impact here - bringing together all of the data to enable collaboration and improve efficiency, quality, yields, savings, and more. Biologics workflows can be improved with standardized methods around collecting, analyzing, managing, aggregating, and displaying data. PerkinElmer has developed biologics capabilities for our E-Notebook and TIBCO® Spotfire visualization and analysis solution. These help researchers capture and organize biologics data that can easily be presented to downstream peers.
Meeting the Needs of Biologics: Data Producers and Data Consumers
In developing biologics capabilities specific to E-Notebook for Merck PerkinElmer helped scientists capture data with content so they can perform sequential and comparative analysis throughout the lifecycle of a product. It also lets lab managers and others assess productivity and cycle time, understand capacity and perform full product lifecycle analysis.
While E-Notebook is primarily regarded as the domain of data producers, facilitating data entry - TIBCO Spotfire® is deployed for data consumers to help them more easily view and interpret biologics data and results in a visual platform. With the ability to query results and see visualizations directly from TIBCO Spotfire®, scientists, business leaders and others throughout an organization can make effective, strategic decisions from E-Notebook data.
If you’re involved in the challenging but rewarding work of biologics, are you working with the best possible solutions to ease complex workflows? Check out information relating to biologics workflows:
Case Study: Supporting Biologics R&D with PerkinElmer Informatics
Webinar: Enhanced Electronic Laboratory Notebook Integrated with TIBCO Spotfire® to Support Biologics R&D
Interactive Demo: Assessment of Bioprocessing Parameters