Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 reported the expansion of its clinical services and technologies capabilities to include technical, project, and operational resources in Asia.  The company has established regional hubs in Singapore and Japan to improve the need to conduct clinical trials in Asia and manage global trials from the region.

As part of the expansion, Almac is building a new secondary packaging facility in Singapore, which is expected to open by the end of 2014.

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Articles

Almac expands technical, project, and operational resources in Asia.

Almac Expands Asia Pacific Operations

 is a new CDMO for the pharmaceutical and related industries, formed from a $2.65 billion transaction between JLL Partners, a private equity firm, and Royal DSM, a life-sciences and materials sciences company. DPx is 51% owned by JLL Partners and 49% by Royal DSM. 

Formerly known by its provisional name “NewCo,” DPx is the corporate parent of a group of business units that is comprised of three brands focused on pharmaceutical services, fine chemicals and products, and proprietary technologies. These units are the result of combining DSM Pharmaceutical Products (DPP), Patheon, and Banner Life Sciences. 

Pharmaceutical services will operate under the Patheon brand name and include the CMO capabilities, pharmaceutical product development services, as well as biosolutions and biologics businesses of DPP. In addition, fine chemicals, or the ES/IM and API businesses, will operate under the brand name DSM Fine Chemicals, while proprietary products and technologies will operate under Banner Life Sciences.

DSM Fine Chemicals will also handle complicated APIs and finished dosage forms, and Banner Life Sciences will offer its own proprietary and nutraceutical products to the market.

DPx’s 2014 sales are expected to be about $2 billion (pro-forma). DPx has 24 locations across North America, Europe, Latin America, and Australia with more than 8000 employees.

$2.6 billion transaction combines Patheon and DSM Pharmaceutical to create CDMO, DPx.

DPx Launched as Provider of Pharmaceutical Services, Fine Chemicals, and Proprietary Technologies

 new facility, located in Midland, Mich., has added $200,000 in instrumentation and brought on several additional analytical and business development experts to support its testing services since its opening in June 2013.
  
  The new instrumentation gives Impact the opportunity to strengthen its core capabilities, including ICP-MS to comply with new USP methods (<232> and <233>) for heavy metals, ion chromatography, an ASE extractor for use in extractables and leachables studies, and a LC-MS Q-TOF system with exact mass capabilities.
  
  The new site includes 35 scientists who operate more than 80 instruments in six areas, including elemental analysis, gas separation, liquid separation, microscopy, molecular characterization, and thermal and mechanical properties.
  
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Impact Analytical's facility in Michigan adds staff and instrumentation.

Impact Analytical Expands Michigan Facility

 announced an agreement with Wyatt Technology for collaboration on products, applications, and technical development for nanoparticle characterization.  As part of the agreement, the developed products will be marketed under the Beckman Coulter Life Sciences brand.

Beckman Coulter partners with Wyatt Technology to develop and market products for nanoparticle characterization.

Beckman Coulter Announces Partnership with Wyatt Technology

 announced an improved Integrated Laboratory Services (ILS) for the life-sciences market at Pittcon 2014,  which includes a range of specialist solutions to help customers increase operational and financial efficiencies and manage risk within their R&D, manufacturing, data center, HQ, and warehousing facilities.

Johnson Controls is responsible for delivering IFM & lab services and supporting quality and compliance for 100 million ft2 of life-science facilities globally, with 40% of those facilities being regulated space.

The life-sciences team has developed a new scientific asset visualization tool, a reporting and analytics tool that enables data-driven decisions and delivers improved lab functions through dashboards and reports, interpreting various data sources, and utilizing its global data warehouse for Integrated Laboratory Services.

Johnson Controls launches Integrated Laboratory Services for R&D facility operations and scientific productivity.

Johnson Controls Launches Integrated Laboratory Services

 celebrated the ten-year anniversary of the ACQUITY UltraPerformance LC (UPLC) System. Over the last ten years, ACQUITY UPLC has had a major effect on laboratories worldwide, both scientifically as well as from a business standpoint.  The ability of the ACQUITY UPLC to perform separations on 1.7 micron particle technology coupled with the ability to operate at 15,000 psi, increased possibilities for analytical testing. The narrow, more concentrated peaks of ACQUITY UPLC improved ionization efficiency. Enhanced resolution and robustness led to reproducible analysis in less time, reducing run times by up to a factor of 10 compared to HPLC technology. 
   
  Waters introduced the ionKey/MS System at the Pittcon Conference and Exposition in March 2014. The system is a new approach for getting sensitivity, robustness, and ease-of-use out of mass spectrometry. Intended for use with Waters ACQUITY UPLC M-Class System and Xevo TQ-S Mass Spectrometer, the Waters ionKey/MS System physically integrates a UPLC separation into the mass spectrometer, thus producing an improvement in sensitivity. This scale of chromatography reduces solvent use and sample size.

The ionKey/MS System’s compact iKey Microfluidic Separation Device contains all components packed inside a 150-micron inner-diameter channel. The iKey device is designed to easily insert into the source of the mass spectrometer to make the fluidic and electrical connections. The eCord Intelligent Chip Technology stores the iKey device’s dimensions, chemistry type, serial number, manufacturing and QC history, and captures and records information such as operator name, instrument name, sample set name, date of first and last injection, total number of injections, observed back pressures, and operating temperatures. 

Waters also introduced the ACQUITY QDa Detector, a small mass-detector that brings mass spectral information to chromatographic separations. Mass spectral information enhances chemical compound identification, which is helpful in laboratories doing method development, sample profiling, chemical synthesis, and purification. The ACQUITY QDa Detector gives analytical chemists the ability to get mass spectral information for all their samples.

The ACQUITY QDa Detector complements optical detection, such as the PDA detector, by confirming the identity of compounds with mass spectral information. Additionally, the ACQUITY QDa Detector extends the limits of sample detection for a chromatographic separation by quantifying compounds having no UV response or that are present at levels not detectable and quantifiable by optical detection. 

In addition, Waters also added a new column oven to its ACQUITY UPC2 System for faster method development and column screening capabilities. The column oven has a capacity of eight columns ranging in length from 50 mm to 250 mm, with internal diameters ranging from 2.1 mm to 8.0 mm. The ability to screen column chemistries, modifier strength, back-pressure settings, and flow rate leads to faster method development and allows for time-efficient scale-up to preparative chromatography.

The temperature controlled column compartment is heated by reticulating air/forced convection having a maximum settable temperature of 90 

C.  The column oven supports a maximum of eight sets of passive pre-heaters, guard columns and analytical columns.  And the oven provides for eight eCord positions ensuring that valuable injection data, column type, data, are captured.

Waters celebrates ten-year anniversary of the ACQUITY UPLC System.