Sigma-Aldrich receives ISO 13485 certification

Sigma-Aldrich Corporation, a leading life science and high technology company, has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St. Louis.

The certification extends Sigma-Aldrich's ability to manufacture and offer critical raw materials, such as enzymes, proteins and antibodies used in diagnostic assays, and provides in vitro diagnostic (IVD) customers with industry-leading assurance of consistent quality to meet and exceed their supply chain needs at a time of increased regulatory requirements.

The Dekalb site, which manufactures enzymes and proteins, achieved the ISO 13485 certification following significant investments in production and packaging facilities as well as personnel training. A similar commitment to invest in capabilities for the diagnostics customer segment enabled ISO 13485 certification of quality management systems at the state-of-the-art Barton distribution warehouse, that can now serve as a central North American distribution center for Sigma-Aldrich raw materials designed for use in IVD manufacturing applications. These two St. Louis-based sites join the growing roster of ISO 13485 certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which manufacture antibodies and enzymes, as well as the St. Louis Ewing site, which provides OEM assay manufacturing services to diagnostic customers.

As one of the leading suppliers of raw materials to the diagnostic market, Sigma-Aldrich made an investment to extend its ISO 13485 certification based on the company's assessment of clients' current and future needs. Sigma-Aldrich continually invests in quality assurance initiatives and has 44 Quality Control laboratories worldwide, as well as approximately 800 employees within the Sigma-Aldrich Quality organisation.

Sigma-Aldrich signs agreement to distribute Roche's biochemical reagents product portfolio

Sigma-Aldrich Corporation, a leading life science and technology company, has signed an exclusive global distribution agreement with Roche. The agreement pairs Roche's high-quality biochemical reagents product portfolio with the industry-leading eCommerce and supply chain capabilities of Sigma-Aldrich.

Under the agreement, Sigma-Aldrich will employ its sales, marketing and eCommerce expertise, and leverage the strength of its relationships with the scientific community, to present and distribute the Roche biochemical reagents product portfolio, which includes kits and enzymes for cellular analysis, proteomics and conventional PCR applications.

"Sigma-Aldrich is excited to offer the global scientific community access to Roche's leading portfolio of scientific tools and reagents. The addition of these life science tools supports our strategy to augment our portfolio with products that accelerate customer scientific research programs," said Eric Green, executive vice president and president, Sigma-Aldrich Research. "We look forward to working with Roche in this relationship."

"This agreement allows us to provide more customers with access to high-quality Roche biochemical reagent products through Sigma-Aldrich's expanded eCommerce and distribution networks," said Paul Brown, head of Roche Molecular Diagnostics. "In addition, this will provide us the flexibility to devote more resources to our primary focus areas."

Transition of the Roche portfolio to Sigma-Aldrich is expected to take place in 2015. In the interim, these products will continue to be available through existing Roche channels.

Sigma introduces Next-Gen Sequencing Oligos

Sigma Life Science, an innovative biological products and services business of Sigma-Aldrich Corporation, released Next-Gen Sequencing Oligos, custom next-generation sequencing adapters that improve target sequence assembly. These oligos are expected to allow researchers to achieve better results from multiplexing experiments. "Sigma-Aldrich is the first oligonucleotide manufacturer to provide a cross-contamination threshold," said Carlos Martinez, development manager at Sigma-Aldrich. "This gives our customers the confidence they need from the start, minimizing the time and expense created by the need to experiment with less consistent products to achieve proper sequence assembly." Next-generation sequencing adapters are required for the proper assembly of genome sample fragments. Adapters, especially barcode sequences, containing unacceptably low full-length sequence or excessive cross-contamination with other barcode sequences can lead to compromised sequence read integrity and improper sequence assembly. These types of problems are often undetectable until the data analysis stage, which make them costly in terms of time and money. Sigma's Next-Gen Sequencing Oligos are manufactured under rigorous conditions to ensure suitable purity and low levels of cross-contamination. "With cross-contamination thresholds as low as 0.25% or less, and both ISO 9001 and 13485 manufacturing available, Next-Gen Sequencing Oligos are ideal for research, life science research tool and molecular diagnostic applications," said Martinez. Sigma Life Science is a Sigma-Aldrich business that represents the company's leadership in innovative biological products and services for the global life science market and offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Sigma-Aldrich, a leading life science and technology company focused on enhancing human health and safety, manufactures and distributes 230,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets.

Merck to acquire Sigma-Aldrich for $17 billion

Merck KGaA, a leading company in the pharmaceutical, chemical and life science sectors, has set to acquire Sigma-Aldrich for $17 billion (€13.1 billion) and establishing one of the leading players in the $130 billion global life science industry.

Merck will acquire all of the outstanding shares of Sigma-Aldrich for $140 per share in cash. The agreed price represents a 37 per cent premium to the latest closing price of $102.37 on September 19, 2014, and a 36 per cent premium to the one-month average closing price. The transaction is expected to be immediately accretive to Merck’s EPS pre and EBITDA margin. Merck expects to achieve annual synergies of approximately €260 million (approximately $340 million), which should be fully realized within three years after closing.

Guggenheim Securities and J.P. Morgan are acting as financial advisers to Merck. Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal adviser to Merck. Morgan Stanley & Co. LLC is acting as financial adviser to Sigma-Aldrich and Sidley Austin LLP is acting as legal adviser.

Sigma-Aldrich enters new gene editing partnership with University of Michigan

Sigma-Aldrich Corporation, a leading life science and high technology company, has entered into a new gene editing partnership with the University of Michigan (U-M) Medical School's Vector Core.

Under the partnership, Sigma-Aldrich will provide the Vector Core with Sigma CRISPR technology, experimental design consultation, and dedicated gene editing bioinformaticians.

The partnership is poised to accelerate gene editing-based research at the U-M Medical School. One initiative already underway, led by Assistant Professor Chad Brenner, involves constructing a large library of Sigma CRISPRs for precision studies of the 100 most common genes that have dysfunctions associated with cancer. Brenner's CRISPR library is expected to support the generation of an unprecedented dataset about oncogene functions and drug resistance, leading to improved decision-making for personalized medical treatment of cancer.

New certified Snap-N-Spike solutions of NBOMe

Sigma-Aldrich Corporation, a leading life science and high technology company, has announced that the Cerilliant brand within its applied diagnostics and testing business segment has introduced six new certified Snap-N-Spike reference standards of designer psychedelics in the NBOMe (N-methoxybenzyl-substituted) class of phenethylamines. New products include 25I-NBOMe HCl, 25C-NBOMe HCl, and 25B-NBOMe HCl and their deuterium labeled internal standards.