AI Issue 12 2017

22 Acquisition International - December 2017 Sartorius Stedim BioOutsource (BioOutsource) is one of the world’s leading providers of contract testing services to the biopharmaceutical and biotechnology industries, offering an extensive range of services to support the testing of biologic drugs and vaccines throughout development and manufacture. We profile the firm to learn more and explore how it came to win The UK’s Leading Contract Test Services Provider – 2017 in our prestigious 2017 UK Excellence Awards. ounded in 2007, Glasgow-based BioOutsource has since flourished to become a pioneer in its industry. The company was the first to develop validated, off-the-shelf cell-based potency assays (bioassays) to substantiate product safety and efficacy similarity per the European Medicines Agency (EMA) guidelines. After reporting 40% year- over-year growth in 2015, the company became part of the Sartorius Stedim Biotech (SSB) group. Since inception, BioOutsource has continued to strengthen its expertise, expanding its industry- leading, off-the-shelf bioassay portfolio, and thereby, reinforcing its global thought leadership standing as it grew alongside the biosimilars market. Over the years, the pioneering company engaged in more than 200 biosimilar development programs with over 50 developers worldwide. Operating in such a competitive and vital field, BioOutsource has to work hard to ensure it stays at the forefront of emerging market developments and is constantly providing clients with the service and solutions they need. The biopharmaceutical industry is constantly changing to react to the demands of providing better healthcare solutions. The emergence of cellular therapies and personalised medicines is an exciting new area that although still in its infancy will without doubt drive significant changes in the way drugs are developed and brought to market. Biologics, such as monoclonal antibodies and recombinant proteins, continue to drive the biopharmaceutical sector due to their targeted therapeutic focus and potent action. However, these life-saving therapies are often out of reach for patients, due to the high treatment costs associated with biologics. Biosimilars, a lower-cost version of the original branded biologicals, represent the next frontier in drug development Biosimilar development is product-specific, requiring technologically complex, sophisticated, and lengthy biological processes, from batch to batch, that must ultimately demonstrate fingerprint- like similarity to the innovator product. Very Company: Sartorius Stedim BioOutsource Address: 1 Technology Terrace, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA, UK Phone: 0141 946 4222 Website: www.biooutsource.com Full SteamAhead for Sartorius Stedim BioOutsource F 1712AI09 few market participants currently have both the technical expertise and capabilities to fulfill the burgeoning demand, however, BioOutsource works with them to offer them an experienced team with strong scientific capabilities, leading technologies, and regulatory compliant processes in place are crucial to project success, but service excellence is key to long-term sustainability. CROs must develop strong relationships with their customers for continuous growth, and as such this is the firm’s constant focus. One of the biggest challenges of working in a fast growing contract testing organisation is being able to align resources to support business growth. Building and retaining strong client relationships through delivering excellent customer service is critical to support this. Over 80% of BioOutsource’s business comes through repeat work from its existing client base, and as such customer loyalty is very important to the firm’s success, and acts as testimony to the level of excellence it provides. Looking to the future, while not losing sight of its core expertise (bioassays), BioOutsource is tapping available growth opportunities by leveraging SSB’s extensive bioprocessing technology platforms, global presence, and wide customer reach. The company combined its deep biosimilar understanding and leading-edge expertise in bioassays with the group’s broader capabilities and expanded geographical footprint to offer a complete product and service combo. For instance, the company utilizes Sartorius Stedim Cellca’s cell line CHO Expression Platform to optimize biosimilar cell line development and SSB’s single-use technologies and value-added services to respond rapidly to changing technology capabilities and market needs. It has also expanded its biological safety testing and chemistry portfolio. Thanks to these additional capabilities, BioOutsource can piece together a fuller picture to its customers, providing complete structural and functional analyses to ensure that their product is, in fact, demonstrating fingerprint-like similarities to the biological reference product at all stages.