Aptuit SSCI Adds Ultra High Resolution Q-TOF Mass Spectrometer for Large & Small Molecule Analyses

GREENWICH, Connecticut, Aug. 22, 2014 /PRNewswire/ — Aptuit LLC announces that Aptuit SSCI, located in West Lafayette, Indiana, has enhanced its capabilities in the areas of structure determination and characterization of small and large molecules, including biologic drugs, metabolites, and polymers, through the addition of the Bruker maXisPlus Q-TOF mass spectrometer.

In making the announcement, Dr. Jonathan Goldman, CEO, Aptuit, said, “The expanded large molecule capability enhances our early development support for the fastest growing sector of the pharmaceutical industry and provides our scientists with the ability to identify active and/or high percentage metabolites in drugs as outlined in the United States Food and Drug Administration Guidance on Metabolites in Safety Testing (MIST).”

Dr. Patrick Tishmack, Director of Analytical Development at Aptuit SSCI, explained that ultra high mass resolution is particularly important in conducting impurity assays of drug substances and drug products, with a limit of detection in the pg/mL to fg/mL range. He clarified the significance of the high sensitivity by saying, “Q-TOF mass spectrometry is a fast and accurate analytical method for characterizing low levels of analytes yet its range from 20 Da to 40,000 Da also enables the analyses of small molecules, polymers, carbohydrates, oligonucleotides, and proteins such as antibodies.”

According to Dr. Tishmack, this addition brings significant value to Aptuit’s clients. “When high resolution mass spectrometry capability is coupled with Aptuit SSCI’s industry-leading expertise in solid state chemistry, the resulting data and corresponding expert scientific interpretation will be at a standard that is unmatched in the contract preclinical research industry.”

The Q-TOF MS, which will be installed and operational by October 2014, will allow unambiguous assignment of molecular formulae for small molecules. In addition to faster sample analysis, generally easier method development is achieved through its implementation. The equipment’s higher throughput translates into a more rapid turnaround for a large number of samples.

For more information, please send an email to info@ssci-inc.com or contact Aptuit SSCI at + 1 800 375 2179.

Aptuit LLC provides the most complete set of integrated early discovery to mid-phase drug development services in the pharmaceutical industry including Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Pharmaceutical Sciences and Aptuit INDiGO® (a fixed-cost program that accelerates drug development). Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 700 employees in Europe and the United States. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.

For more information about Aptuit, visit www.aptuit.com.

Biocompatible Protective Coatings Widen Application Scope in Medical Devices, Finds Frost & Sullivan

— Blended products that include therapeutic coatings of different materials are making waves in the industry

MOUNTAIN VIEW, Calif., Aug. 12, 2014 /PRNewswire/ — Innovations will surge in the protective coatings industry by 2020, giving rise to a range of improved biocompatible and durable coatings that enable implant devices for use in orthopedic, orthodontic and cardiac applications. The International Organization for Standardization (ISO) and American Society for Testing and Materials (ASTM) are creating new standards for upcoming industry trends in protective coatings, further encouraging patent developments.

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New analysis from Frost & Sullivan, Innovations in Protective Coatings for Medical Devices, finds that increasing biocompatibility is a major driver for implant coatings. Successful implant coatings enhance biocompatibility and promote healing processes by minimizing tissue rejection and better anchoring implants to the targeted area.

For complimentary access to more information on this research, please visit: http://bit.ly/1sl6idw.

Passivation – accomplished by coating implant material with polymer layers – is an upcoming area of research in coatings for biomedical applications. Passivation techniques have been successfully used in development of coatings and biomaterials to manufacture the most biocompatible implants.

“This is particularly important in cases of load-bearing implants with need for mechanical strength,” said Technical Insights Research Analyst Sanchari Chatterjee. “Developing specialized coatings and techniques that prevent aggressive cell growth and aid the production of desirable endothelial cells rather than smooth muscle cells will also be crucial.”

However, protective coatings require sophisticated raw materials that incur high costs. For instance, low availability of titanium, coupled with demand from industries such as aerospace, industrial and recreation make it an expensive resource.

Developing novel coating materials has been a trend in the industry for the last two years.  For example, use of spider silk, which is hypoallergenic, biodegradable and usable as coating for implants or as a drug carrier in pharmaceutics, is being researched as a coating for silicone implants.

In the meantime, combination products such as therapeutic coatings of different materials are creating a stir in the industry. Coatings that use solutions as surface treatments too are gaining momentum. For instance, bone implant surfaces enriched with biomolecules can accelerate the bone healing process.

“Research institutes have joined forces with industry players to evaluate a wide variety of biomolecules such as growth factors, bioactive proteins, enzymes and non-viral genes,” added Technical Insights Research Analyst Vivek Ninkileri. “As is evident, stakeholder initiatives, especially collaboration among research institutes, academia and medical device manufacturers will play a major role in the advancement of protective coating technologies.”

Innovations in Protective Coatings for Medical Devices, a part of the Technical Insights (http://www.technicalinsights.frost.com) subscription, analyses key innovations in protective coatings for medical devices to distinguish the chief developments and challenges in the market. Opportunity strategy evaluation, technology roadmap, impact analysis, and R&D development strategies are also discussed. Further, this study includes detailed technology analysis and industry trends evaluated following extensive interviews with market participants.

Technical Insights is an international technology analysis business that produces a variety of technical news alerts, newsletters, and research services.

About Frost & Sullivan

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Innovations in Protective Coatings for Medical Devices

Ariel Brown
Corporate Communications – North America
P: (210) 247.2481
F: (210) 348.1003
E: ariel.brown@frost.com


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