Researchers Pinpoint Mechanism In Malaria Drug Resistance

Researchers from the Washington University School of Medicine in St. Louis reported their discovery of a mechanism behind malaria parasites’ drug resistance. The discovery may also apply to other infectious diseases, such as tuberculosis and bacterial infections.

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  • Women In Bio Profile - Lessons Learned From 10 Years Performing Tech Transfers
    Women In Bio Profile - Lessons Learned From 10 Years Performing Tech Transfers

    Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.

  • Sustainable Pharmaceutical Packaging
    Sustainable Pharmaceutical Packaging

    The concept of sustainability has been a topic of interest for many years. Cur-rent international focus has led to the development of regulatory guidance in many of the world’s markets. Along with sterility assurance, process validation, and regulatory compliance, sustainability is becoming a high-profile issue and is considered a critical factor in the design of healthcare facilities, equipment, products, and packaging. By Chuck Reed and Mel Bahr

  • <I>Discovery Fast Track</i> At GSK Assists Academia And Adds To The Pipeline
    Discovery Fast Track At GSK Assists Academia And Adds To The Pipeline

    GlaxoSmithKline (GSK), like so many other pharmaceutical and biotechnology companies, is looking to boost its pipeline. Pearl Huang, Ph.D., vice president and global head of GSK’s Discovery Partnerships with Academia (DPAc), is taking direct aim at the drug discovery concept stage to take up the challenge. By Louis Garguilo, Executive Editor, Outsourced Pharma

  • How To Prepare A Facility For The Biopharmaceutical Revolution
    How To Prepare A Facility For The Biopharmaceutical Revolution

    Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

  • Analytical QbD at Teva: Knowledge Is Power Only When You Share It
    Analytical QbD at Teva: Knowledge Is Power Only When You Share It

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

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  • Securing Provision K Status For A Client’s API Helps To Expedite Shipping And Reduce US Importation Costs

    Active pharmaceutical ingredients (APIs) also known as bulk active pharmaceutical ingredients, are defined by the US Food and Drugs Administration (FDA) as ‘any component that provides pharmacological activity or other effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or animals.’ Generally, APIs are therapeutic components of drug formulations or finished pharmaceutical products that also contain fillers, binders’ excipients and other inactive ingredients. APIs are routinely evaluated or used by pharmaceutical companies for preclinical testing during new drug development, human clinical trials testing and commercial manufacturing of approved pharmaceutical products.

  • Utilization Of Customs Warehouses In The Clinical Trial Supply Chain

    The global clinical trial supply chain industry has been seeking new opportunities to improve efficiency for many years. As pressures to decrease cost and reduce time to market continue to rise, the design of the clinical trial supply chain must evolve and change to meet those demands.

  • Following The Lead From Big Pharma Or Biotech May Not Identify The Right Supplier For Emerging/Niche Or Start-Up Companies

    A couple of years ago, Nice Insight explored how the essential qualities for outsourcing relationships varied between
    large and midsized companies, in addition to traditional pharma companies versus biotechs. As one would imagine,
    these essentials differ quite a bit from emerging or start-up companies, as their needs when it comes to outsourcing are different from larger companies’. 

  • An Update On The Buzz Around Oncology

    The heightened interest in developing cancer treatments, combined with the R&D efforts contributed to the emergence of a class of “smart bombs” first reported as one of their most hopeful developments at the American Society of Clinical Oncology’s annual meeting in June of 2012.

  • Life Science Industry Partnerships With Patient Foundations: The Best Practices

    Voices of BayBio’s “Successful Public-Private Partnerships” Survey

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    Gen5™ V2 Data Analysis Software Gen5™ 2.0 is an all-in-one microplate reader software designed to give users an enhanced experience. All areas of the interface have been reviewed and redesigned by microplate experts to combine power and flexibility with ease-of-use and memorable visuals.
  • BraillePoint&trade; Braille Dot Measurement
    BraillePoint™ Braille Dot Measurement Global Vision's BraillePoint is a fast, and easy to use Braille dot verification tool perfect for the measurement of Braille dot height and placement.
  • CHO Media Development Kit
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    The diversity of the media panel in the CHO Media Development Kit(TM) allows you to create a formulation development strategy that fits with your project timeline, resources, and goals.

  • Davisil® Chromatographic Silica
    Davisil® Chromatographic Silica Recognized worldwide as media of high purity, Davisil® silica is the cornerstone of Grace’s offering of silica media products. With excellent mechanical and structural properties, Davisil® silicas are versatile, consistent, and reliable. They are ideal for scale-up to industrial process applications.
  • Process Optimization And Scale-Up Of Freeze Dry Products
    Process Optimization And Scale-Up Of Freeze Dry Products

    Freeze drying cycles are optimized with respect to specific product, formulation, batch and equipment parameters. A change in any of these may affect the behavior of the product during the cycle.

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  • Temperature Monitoring Technology for Healthcare Shipments
    Temperature Monitoring Technology for Healthcare Shipments

    Logistics expert Kevin O’Donnell, Senior Partner, Exelsius Cold Chain Management, presents the basics of temperature monitoring for healthcare shipments. From simple temperature indicators to more sophisticated electronic systems that include intervention protocols, you have more options than you may think. Kevin Etter, Product Manager, UPS Global Healthcare Logistics Strategy Group, explains why it’s so important to know what's going on during high value shipments.

  • How To Assess Total Logistics Cost
    How To Assess Total Logistics Cost

    Watch this new video to learn new ways to calculate total logistics costs. Susan Li of the Healthcare Strategy Group at UPS reveals the true costs of packaging and shipping.

  • Biobanking And The Future Of Translational Medicine: Dr Gyorgy Marko-Varga Interview 2 Of 3 Dr Gyorgy Marko-Varga highlights how biobanking will be critical to realize the promise of Translational Medicine and what challenges we need to overcome quality hurdles going forward.
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  • Pall Life Sciences - BioPharmaceuticals
    Pall Life Sciences - BioPharmaceuticals

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  • Southwest Airlines Cargo
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  • BioTek Instruments, Inc.
    BioTek Instruments, Inc. BioTek Instruments, Inc. is a global leader in the development, manufacture and sale of microplate instrumentation and software. The company's origins date back to 1968, when Dr. Norman Alpert, a physiologist at the University of Vermont Medical College, founded BioTek. Dedicated to providing test equipment solutions for the hospital safety and quality assurance markets, BioTek's Biomedical Division grew to become one of the largest and most successful companies in the field.
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Remote Monitoring of Clinical Source Data – Why Not?

July 28, 2014
1pm-2:30pm EDT, Online Training

Building An Effective GMP Training System: A Risk-Based Approach

July 30, 2014
1pm-2:30pm EDT, Online Training

Improving Biological Facility Design: Critical Tips for Compliance

August 6, 2014
1pm-2:30pm EDT, Online Training

Serialization Preparedness – What you Must Know for Bullet-Proof Programs

August 12, 2014
1pm-2:30pm EDT, Online Training
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Remote Monitoring of Clinical Source Data – Why Not?

July 28, 2014
1pm-2:30pm EDT, Online Training

Building An Effective GMP Training System: A Risk-Based Approach

July 30, 2014
1pm-2:30pm EDT, Online Training

Improving Biological Facility Design: Critical Tips for Compliance

August 6, 2014
1pm-2:30pm EDT, Online Training

Serialization Preparedness – What you Must Know for Bullet-Proof Programs

August 12, 2014
1pm-2:30pm EDT, Online Training
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