Houston-Based Biotech Firm ApoCell, Inc. has expanded its operations into Europe, announcing this week that it has established offices and laboratories in Leipzig, Germany. The new facility will facilitate better service to existing clients and capitalization of growing opportunities to provide ApoCell’s leading-edge molecular biomarker detection and analysis services to new European clients.
ApoCell Europe GmbH, a newly formed division of privately-held ApoCell, Inc. has also entered a new collaboration with the Fraunhofer Institute for Cell Therapy and Immunology, a non-profit German research institute, to further develop ApoCell’s proprietary circulating tumor cell (CTC) isolation technology, ApoStream for clinical applications.
“Our opportunities in Europe continue to grow and have led to this strategic expansion,” says Darren Davis, president and CEO of ApoCell in a release, adding that ApoCell’s European office will primarily serve to enhance communication and collaboration with existing clients and to develop new clinical trial services business.
ApoCell’s Christoph Sachsenmaier, vice president of business development – Europe, will lead activities to expand the biomarker clinical trial services. A molecular biologist by training with a Ph.D. from University of Innsbruck, Austria, Dr. Sachsenmaier has more than 20 years of experience in the biotechnology and life sciences sector.
“Christoph has the strong scientific background and in-depth clinical trial experience needed to be a capable leader for our European expansion,” says Mr. Davis. “We are fortunate to have him as a part of our team.”
Mr. Davis also confirmed that ApoCell’s laboratory in Houston will continue to serve as the company’s corporate headquarters.
As part of the cooperative project with Fraunhofer IZI, ApoCell will continue to develop the ApoStream device, optimize technical parameters, improve ease of operation and increase system performance efficiency. “We have declared it our goal to develop an FDA Class I, CE marked investigational use only (IUO) instrument within the next year for use in clinical studies to generate data for in vitro diagnostic applications,” says Mr. Davis, who serves as managing director of ApoCell Europe GmbH.
Apocell notes that circulating tumor cells (CTCs) and other rare circulating cells have inherent differences from peripheral blood mononuclear cells (PBMCs) in morphology and dielectric properties (polarisability) of cells that are dependent upon cell diameter, membrane area, density, conductivity and volume.
ApoCell’s ApoStream technology leverages these differences in a micro-channel flow field to isolate CTCs using a process called dielectrophoresis field flow fractionation (DEP-FFF). A combination of forces, dominated by the electrophoretic charge, attracts or repels cells to a charged electrode. Differential flow rates relative to distance from the electrode are used to fractionate cell types.
Electric fields at lower level pull tumor cells towards the microelectrode array on the chamber floor and repel blood cells in the eluant. Tumor cells therefore experience retardation, thus slowing their transit through the chamber while blood cells are carried away by the eluant.
ApoStream technology exploits dissimilarities of different cell types that arise from morphological and electrical properties to isolate a variety of rare cells from whole blood, independent of EpCAM expression. Data collected from more than 80 tumor cell lines has shown that CTCs exhibit distinctly different dielectric properties as compared to PBMCs, and the isolated and recovered cells maintain cell viability and can be used for downstream analysis.
ApoStream CTC Imaging successfully isolates single cells and tumor cell aggregates from the circulation that are vital for cancer cell survival in circulation.
ApoStream Key Benefits include:
• CTCs from a variety of cancers
• High recovery and high purity
• Isolated cells are intact, viable, and can be cultured
• Whole blood processing, with small starting volume
• Non-capture – cell contact is minimal
• Minimal cell loss during processing steps
• Other rare cell (CEC, CEP, stem cell etc.) isolation
The Fraunhofer Institute for Cell Therapy and Immunology IZI investigates and develops solutions to specific problems at the interfaces of medicine, life sciences and engineering. The Institute develops, optimizes and validates methods and products for the Business Units Drugs, Cell Therapy, Diagnostics and Biobanks, and its competencies include biomarkers, antibodies / ligands, stem cell technology and imaging as well as therapeutic and diagnostic model systems (in vitro / in vivo). Another emphasis is on quality management according to GLP and GMP and on the Institute’s several years of experience in the operation of clean room facilities.
As part of the collaboration, Fraunhofer IZI will provide various model systems and analytical procedures in order to test the effectiveness of the isolation method as well as to evaluate the significance of the circulating tumor cells. The respective cells are to be cultivated in the laboratory and thoroughly characterized, both genetically and biochemically. In order to make circulating tumor cells available for prognoses and diagnoses for the purpose of personalized therapy, new biomarkers are to be identified by means of comprehensive genetic and biochemical analyses.
“The technology is intended to help make therapy more effective and cost-efficient. To do this we first have to thoroughly exploit the diagnostic potential of the circulating tumor cells,” says Professor Friedemann Horn, head of the Department of Diagnostics at Fraunhofer IZI in the ApoCell release.
The joint project, valued at approximately four million Euros, is being funded through the Sächsische Aufbaubank (Saxon Development Bank) with a total of three million Euros coming from the European Regional Development Fund (ERDF) and also from the Free State of Saxony.
“We are extremely pleased that we have been able to bring on board ApoCell, Inc. — another well-known, international partner — to invest in the biotechnology region of Saxony,” comments Dr. Thomas Tradler, Head of Business Development at Fraunhofer IZI.
Mr. Davis notes that ApoCell’s continued dynamic growth is fueled in part by the strong interest in ApoStream, which ApoCell has successfully incorporated into at least 20 ongoing early and late stage clinical trials as part of its biomarker analysis services. He affirms that the company’s proprietary methods provide early proof of mechanism of action and monitor the effectiveness of various types of drugs by measuring biomarker expression patterns in biopsies, blood and rare cell types. Since inception, ApoCell has participated in over 140 Phase I, II, and III clinical cancer drug trials for more than 80 sponsor clients worldwide. A privately-held company, ApoCell was recently named to annual Inc. 5000 list of fastest-growing U.S. companies for the third consecutive year.
More information about ApoCell can be found at:
Founded in 2004 and based in Houston,, ApoCell (http://www.apocell.com) is a privately-held specialty clinical research company that has been a leader in molecular biomarker detection and analysis, leveraging its expertise in the areas of oncology, diabetes, molecular diagnostics and drug development to measure biomarker signatures in clinical trial subjects. The company’s proprietary methods provide early proof of mechanism of action and monitor the effectiveness of various types of drugs by measuring biomarker expression patterns in biopsies, blood and rare cell types. The company’s facilities are CLIA-certified and compliant with applicable FDA regulations. Since inception, the company has participated in over 140 Phase I, II, and III clinical cancer drug trials for more than 80 sponsor clients worldwide.
More information about ApoCell can be found at:
The Fraunhofer Institute for Cell Therapy and Immunology IZI was founded in April 2005, and is a member of the Fraunhofer Life Sciences Alliance. The Institute’s mission objective is to find solutions to specific problems at the interfaces between medicine, life sciences and engineering for partners active in medicine-related industries and businesses. The Fraunhofer IZI offers research and development services in the Business Units Drugs, Cell Therapy, Diagnostics and Biobanks. The Institute’s core competencies are to be found in regenerative medicine, or more precisely in cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). In order for the living organism to accept the tissues without any difficulty, it is necessary to study cellular and immunological defense and control mechanisms and take these into account during process and product development.
The Institute investigates and develops specific problem solutions at the interfaces of medicine, life sciences and engineering, and practices contract research for biotechnological, pharmaceutical and medical-technological companies, hospitals, diagnostic laboratories and research facilities. Within the Business Units of Agents, Cell Therapy, Diagnostic and Biobanking, the Institute develops, optimizes and validates methods, materials and products. The Institute’s core competencies are located in the field of Regenerative Medicine, in particular in the indication areas of oncology, schema and autoimmune, inflammatory and infectious diseases. The Institute is clinically oriented and conducts quality checks and the GMP-compliant manufacture of investigational medicinal products. Moreover, the Institute provides support in obtaining manufacturing authorizations and approvals.
These core competencies entail a multiplicity of tasks to be solved by new products and processes. The Institute works especially closely with hospital institutions, performing quality tests and clinical studies in cooperation with partners. Additionally it also provides assistance in obtaining manufacturing licenses and certifications.
The building of the institute was finished in April 2008. With an effective area of 4500 sq. (2300 sq. laboratory space and 1400 sq. office space) the building offers space for 200 employees. The approx. 24 million euro building project was supported by the European Union, the Federal Republic of Germany, the Freestone of Saxon and the city Leipzig.
More information about The Fraunhofer Institute for Cell Therapy and Immunology can be found at:
The Fraunhofer Institute for Cell Therapy and Immunology