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INDUSTRY NEWS


Sartorius Stedim Biotech Opens New Bioanalytical Testing Laboratory in Boston


Sartorius Stedim Biotech has opened a new bioanalytical and biosafety testing laboratory yesterday in the major biotech hub of Boston, Massachusetts. This dedicated bioanalytical laboratory is designed to accommodate the rising demand for the company’s BioOutsource brand specialized assay platforms in North America and facilitate the ongoing expansion of this unique service offering.


At the opening ceremony, Reinhardt Vogt, member of SSB’s Executive Committee, welcomed many representatives from the biotech industry and the local community to the new laboratory. In his opening speech, Reinhard Vogt stated: “Our new laboratory will offer customers the analytical expertise to help them accelerate entry into clinical phases. We chose Boston as the site for our laboratory because it is a premier biotech hub, enabling us to showcase our portfolio of bioanalytical and biosafety tests, as well as attract the best technical staff to continue our expansion here in the future.”


The purpose-built laboratory features state-of-the-art technology, such as biacore analytical instruments, and offers advanced analytical testing services. These include Antibody Dependent Cell Cytotoxicity (ADCC); Complement Dependent Cytotoxicity (CDC) and Surface Plasmon Resonance (SPR) assay platforms; as well as cell- based assays and enzyme-linked immunosorbent assays (ELISAs). SSB’s new laboratory, which covers approximately 9,000 sq. ft. (830 m2), will also provide GMP-compliant in vitro and PCR-based assays for the detection of adventitious agents. Staffed by bioanalytical experts, including 15 scientists, the new laboratory provides easy access for customers to visit and have face-to-face meetings to discuss technical questions.


Bionical Acquires Emas Pharma


Bionical, an integrated outsourced specialist to the pharmaceutical, biotechnology and public health industry, announced the strategic acquisition of Emas Pharma (Emas), a global Clinical Research Organization. Emas, which provides pharmaceutical development and clinical research services to biotech, medical device and specialized pharmaceutical companies worldwide, will join Bionical's existing fast growing clinical services business. Financials were not disclosed.


The acquisition is part of Bionical's strategy to provide high quality clinical, commercial and communications services to pharmaceutical, biotech and public health companies in the global healthcare industry.


The acquisition of Emas and the addition of Clinical Research, Pharmacovigilance, Regulatory, Medical Information and Medical Affairs capabilities will support Bionical's mission to deliver improved health outcomes for patients. Bionical's clinical division currently provides the supply of comparator products for clinical trials as well as nurse educator teams and public health services and has a wide base of clients internationally. Emas, which has a significant client base of emerging and specialized biopharma companies, brings an extended global footprint, with offices in the UK, USA, Canada, Australia and Ireland.


Graham McIntosh, CEO of Bionical, commented: "Emas Pharma is a fantastic business with great people and an excellent reputation. Emas's services are highly complementary to Bionical's existing clinical trial services and the acquisition creates opportunities for both businesses to bring enhanced services to their clients. We are very pleased Peter Kennerley, Liz McCann and the Emas team are now a part of Bionical and I look forward to working with them to continue the global growth of Emas."


Dr Peter Kennerley, CEO of Emas Pharma, commented: "We are delighted to join the Bionical group, which is a perfect synergy for Emas Pharma. Being part of a wider family of companies means that we will be offering our clients an even broader range of services to complement our current offerings; from nurse specialists to help track patients lost to follow up, to call centres for Medical Information and from Clinical Trial Supply support to healthcare communications. Liz and I are proud of the excellent reputation for high quality, cost effective support that Emas has built up over the years. We know that joining Mac and the Bionical team will help us extend that reputation even further."


Emas will continue to operate as a separate business under the existing leadership of Peter Kennerley and Peter will join the Bionical Board.


Sirona Dx Expands Next Generation Sequencing Services to Include Oncomine Focus Assay for Pharmaceutical Clients


Sirona Dx, a supplier of high complexity genomics and proteomics services, has adopted Thermo Fisher Scientific’s Oncomine Focus Assay to run on the Ion PGM System and will expand its drug development and next generation sequencing (NGS) services offered to pharmaceutical and clinical research clients.


Sirona Dx recognizes that pharmaceutical companies require access to genomic expertise as well as multiple platforms and technologies to support oncology clinical research studies. After its comprehensive evaluation and validation, Sirona Dx chose to complement its current service offerings with the Oncomine Focus Assay, which includes 52 solid tumor genes, many associated with current oncology therapies and published evidence.


“We are in a revolutionary time in the world of cancer research. The ability to understand the specific genomic makeup of a tumor and have that information drive drug development and eventually treatment is empowering,” said Nasry Yassa, Ph.D., Chief Executive Officer of Sirona Dx. “The Oncomine Focus Assay represents the best of what is available in terms of content and technology.”


The assay’s content is driven by the Oncomine Knowledgebase, the world’s largest curated compendium of cancer genomic information and confirmed with industry-leading pharmaceutical companies, to help enable a more unified approach to companion diagnostic and drug development. It is powered by proven Ion AmpliSeq technology to enable detection of single nucleotide somatic changes, inversions, insertions and deletions, as well as gene fusions and copy number


Pharmaceutical Outsourcing | 46 | November/December 2016


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