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A New Kind of
Biosimilar Partner
Jump-start your biosimilar program today with pre-qualified analytical methods, detailed reference product characterization, and off-the-shelf assets proven to meet your product quality and productivity requirements
Patent
Discovery
We start every program with detailed patent discovery work, finding all valid and relevant patents in the US and EU. We then work with law firms dedicated to intellectual property law in the pharmaceutical industry to ensure we have a comprehensive understanding of the key patents, anticipated timing of biosimilar competition, and freedom to operate as we begin pre-clinical development.
Analytical
Development
We complete every aspect of analytical development for each program, including reference product sourcing and characterization, definition of a Quality Target Product Profile, identification of Critical Quality Attributes, and development of the full complement of analytical methods needed to characterize and control the biosimilar.
Cell Line
Development
We screen a range of biosimilar cell lines for each program, including the Selexis SURE CHO-M Cell Line™ technology, to best optimize product quality, titer, and cell line stability. All of our cell lines include single cell cloning and production of a research cell bank.
Process
Development
We provide end-to-end biosimilar development processes from early upstream development through completion of a commercially viable manufacturing process in under 10 months – a process that delivers high-quality supplies of drug product for non-clinical and clinical studies. We confirm analytical similarity at every step giving you confidence that the program will be clinically successful.
Similis provides complete solutions for Chemistry, Manufacturing, and Controls, from target selection, through drug product delivery.
Learn more about the programs we are working on by exploring our pipelines below!
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Analytical Data Pipeline
Analytical Data Pipeline depicting the Product Quality Summary, Analytical Starting Package, and Extended Characterization Package.
Asset Development Pipeline
Asset Development Pipeline describing cGMP Manufacturing, Process Development, and Cell Line Development.
We believe in a world where exceptional biologics are universally accessible, made possible by harnessing transformational technology and latent data.
John Gabrielson
SVP, Biosimilars & Head of Business
John is a seasoned executive, company builder, and strategist with over 15 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading CDMO, John is now focused on accelerating biosimilar adoption across the industry.
Dayn Sommer
Director, BD & Alliance Management
After completing his doctoral work in 2016 at Arizona State University in biochemistry, Dayn joined KBI Biopharma as an analytical scientist supporting CMC service offerings, before switching to BD operations. His current role supports business development efforts, contract development and partnership negotiations.
Jared Young
Director, Biosimilar Strategy
Jared has over 8 years of experience developing biologics. He has worked on hundreds of biologics programs and over 15 biosimilar programs. Additionally, Jared has written multiple articles and book chapters, including chapters of the book “Biosimilars” about biosimilar development.
Andrea Adam
Director, Biosimilar Operations
Andrea has 15+ years of program management and operations experience within the biotechnology industry. With broad experience across all aspects of CMC development, her efforts will focus on defining portfolio strategy and driving executional excellence.
Brad Prater
Director, Product & Process Development
Brad has 20+ years of biologics development experience, spanning development through commercial lifecycle management. He is focused on identifying the critical quality attributes of biosimilars across the portfolio and driving process development to meet those product quality targets.
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