BIO INDUSTRY NEWS

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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FEATURED ARTICLES

  • 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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BIORESEARCH INSIGHT

  • 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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FEATURED PRODUCTS

  • Filter Housings For Depth Filter Modules
    Filter Housings For Depth Filter Modules Pall Corporation has used design, cost, and industry expectation as the creative foundation of our depth filter technology.
  • 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.

  • Gen5&trade; V2 Data Analysis Software
    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.
  • Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing
    Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

    Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.

  • Bio-Rad Process Chromatography Applications Laboratory
    Bio-Rad Process Chromatography Applications Laboratory Bio-Rad Laboratories welcomes you to our pilot-scale development laboratory for process chromatography located at our headquarters in Hercules, California.
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BIORESEARCH ONLINE VIDEOS

  • 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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FEATURED SUPPLIERS

  • Pall Life Sciences - BioPharmaceuticals
    Pall Life Sciences - BioPharmaceuticals

    The life sciences industry is both driven and united by its need for speed to market, product reliability and economics. Pall Corporation’s leading edge technologies and services play an essential and pivotal role in this industry’s ability to achieve these goals...

  • Southwest Airlines Cargo
    Southwest Airlines Cargo

    At Southwest Airlines Cargo®, we understand the urgency of pharmaceutical shipments and know that sometimes overnight is not an option. With Relentlessly Reliable® air cargo service to over 90 destinations, we provide exceptional care so your time critical shipment will arrive ontime, as planned.

  • 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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CMO CRO LEADERSHIP AWARDS

Life Science Leader developed the CMO and CRO Leadership Awards based on industry leading research conducted by Nice Insight. The awards help pharma and biopharm companies focus on potential partners who can handle their projects and are considered reputable in the industry. Click on the logos above to visit this year’s winners.

 

ABOUT BIORESEARCH ONLINE

Welcome to BioResearch Online, the premier Internet source of useful and timely information for the worldwide bioresearch and life sciences industries. This site is designed to serve the needs of laboratory directors, laboratory managers, researchers, scientists, university faculty members, business executives, and other industry professionals. BioResearch Online provides daily news updates and in-depth feature stories about drug discovery, research and development advancements, university-industry collaborations, and regulatory issues.

On this site, industry professionals will find information about new products and technology, bioanalytics, bioreactors, biopurification, bioproduction products, bioprocess sensors, cell culture media, biopharm contract manufacturing, chromatography, lab informatics, lab automation, laboratory systems and equipment, molecular and cell biology, pipettors, assay instruments, genetic sequencing, immunochemicals, enzymes, hardware and software systems, and more.

Bioresearch Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute.

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 UPCOMING TRAINING COURSES

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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