September 15, 2009 (Vol. 29, No. 16)
Opening of CDMO Coincides with Strategic Move Targeting Pharmaceuticals and Biologics
Symyx Technologies recently launched a contract development and manufacturing organization (CDMO) to help biopharmaceutical companies move drug candidates into clinical trials.
“After discovery, the next critical milestone in drug development is getting to trials quickly with a reliable formulation. Our CDMO gives clients a fast, reliable route to clinical trials,” says Richard Boehner, president of Symyx High Productivity Research (HPR).
Due to less than optimal formulations, some clinical trials become a test of a drug’s formulation limitations rather than its effectiveness. The Symyx CDMO, which is part of the HPR business unit, focuses on preformulation development, formulation optimization and stability, and analytical methods development, all of which are intended to insure optimized and robust drug formulations. The CDMO also offers fill/finish services for products manufactured under cGMP conditions in quantities to meet preclinical and Phase II and II trials.
Symyx was founded in 1994 to pioneer combinatorial chemistry and high-throughput technologies to advance scientific informatics. For 15 years, the company has performed contract work in materials science for semiconductor, chemical, and energy companies.
Symyx assisted Dow Chemical, an early customer, in designing catalysts used to manufacture Dow’s Versify™ line of plastomers and elastomers. Collaborations with ExxonMobil reportedly accelerated the development of chemicals, lubricants, and fuel products. Large pharmaceutical companies also signed on as clients to improve formulations of small molecule drugs.
Push Into Biologics
An internal strategic review two years ago pointed to the pharmaceutical industry, particularly those working with biologics, as the next growth area for Symyx.
“Most of the major pharmaceutical companies already use our tools, so it was not a big leap to move into larger molecules and biologics,” says Boehner.
Symyx recently purchased Integrity Biosolution to strengthen the services that it offers to life science researchers. The company had experience in contract formulation research and analytical services for large molecule biopharmaceuticals, as well as manufacturing and fill/finish services, and early clinical trial expertise. “Integrity Biosolution had a strong foundation for solving formulation problems for large molecules,” notes Matthew Pino, vp, Symyx CDMO.
According to Pino, researchers at Integrity Biosolution solved problems that had proved too difficult for customers to handle inhouse such as characterization or aggregation issues. Integrity Biosolution then found stable formulations and moved products into the next stage of development, he adds.
The methods and expertise developed at Integrity Biosolution are now rolled into Symyx CDMO, which combines aspects of traditional contract research organizations (CROs) and traditional contract manufacturing organizations (CMOs). CROs generally focus on toxicology studies, clinical trials, and formulation development, whereas CMOs specialize in late-stage commercial product development and manufacturing.
The Symyx CDMO is integrating all these development services “to move products from discovery into the clinic,” says Eric Carlson, vp of life science technology at Symyx. Additionally, Symyx’s informatic products for collecting laboratory data, generating shared reports, and integrating automated technologies are expected to provide value to the CDMO’s operations.
Symyx has developed a good understanding of workflows the process scientists follow in designing studies such as preparing samples, performing analysis, querying data, drawing conclusions, and generating reports. This process requires laboratory stations, equipment and software to unite the steps, and chemical know-how to guide the process. “We’re now able to integrate our workflow expertise with Integrity Biosolution’s formulation expertise,” says Carlson.
Broadening Its Business Base
Symyx also targets companies that have product pipelines that match the services offered by the CDMO. By building up a portfolio of products and companies, Symyx intends to not only broaden its business base, but also strengthen its software and high-productivity research units.
Other core capabilities of Symyx include scientific information management, microscale, parallel experimentation, and contract research. Boehner points out that Symyx was a pioneer in microscale, parallel high-throughput technology that combines automation with advanced informatics. The technology makes it possible to run hundreds or thousands of experiments in parallel to streamline workflow tasks such as solubility profiling, liquid formulations, and excipient compatibility, he says.
Scientists can experiment with milligrams, rather than grams, of a costly chemical in early-stage development. Informatics improves data visualization and analysis as large comprehensive data sets are delivered in days, rather than weeks or months. Compounds that hold promise are separated from dead ends, shortening the discovery path.
Symyx HPR products consist of specialized tools that combine microscale, high-throughput technology and lab automation software to reduce the amount of expensive chemicals needed for early-stage experiments.
Symyx is also a purveyor of specialized electronic notebook, data acquisition, and decision-support software and scientific databases. These products give scientists access to personal, corporate, and public sources of data to support information-driven research and development processes.
As laboratories phase out paper record keeping, electronic notebooks are improving the collection, analysis, and accessibility of data. Symyx’s software portfolio was designed to support the capture of notebook and instrument-generated information into repositories.