FROM THE EDITOR

  •  BPI Offers A Look Into QbD At Genentech
    BPI Offers A Look Into QbD At Genentech

    Brian Horvath, Scientist and Technical Development Team Leader, Late Stage Cell Culture at Genentech, says the company’s QbD approach has been evolving over the past several years. It is used in a number of ways in the bioprocess areas—cell culture, purification, and formulation—which allows validation that the process as a whole reliably produces product with the desired critical quality attributes. In October, Horvath, will present a case study at the BioProcess International Conference and Exhibition outlining how QbD was used at Genentech during the characterization of a CHO-based monoclonal antibody.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • A Witness To The History of Outsourcing
    A Witness To The History of Outsourcing

    Joe Guiles seems too young and mild-mannered to have been at the outbreak of a revolution that began many years ago. But he witnessed firsthand the inception of what would become the complete penetrability of outsourcing throughout the drug industry. 

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BIORESEARCH INSIGHT

  • Innovations In Purification: Lowering Cost And Accelerating Drug Development With Pre-Packed Columns For Single Use
    Innovations In Purification: Lowering Cost And Accelerating Drug Development With Pre-Packed Columns For Single Use

    Monoclonal antibodies (mAbs) are becoming key therapeutic agents for treating complex diseases, such as rheumatoid arthritis and cancer, as well as niche and rare disorders. By Carol Preisig, Ph.D.

  • New Requirements In Global Clinical Supply Spur Evolution And Innovation
    New Requirements In Global Clinical Supply Spur Evolution And Innovation

    Who knew clinical trial logistics had so much in common with the automotive and high-tech industries? That certainly seems to be the case with trends like just-in-time (JIT), customer-managed inventory (CMI) and vendor-managed inventory (VMI).

  • Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
    Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Sr. Manager, HyClone Cell Culture, GE Healthcare

    The industry is abuzz with talk about continuous biomanufacturing (CB), and it virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

  • NatriFlo HD-Q Membrane Adsorber Comparison Study

    Strong anion exchange (Q) chromatography has become an industry standard in the polish purification steps of mAb production.

  • Live Cell Hypoxia Determination In A 3D Spheroid Model
    Live Cell Hypoxia Determination In A 3D Spheroid Model

    Cell-based assays provide a wealth of drug screening information compared to their biochemical counterparts, and at a fraction of the cost and time seen with traditional animal models.

  • Boehringer Ingelheim Ups The Ante In Treating Lung Disorders
    Boehringer Ingelheim Ups The Ante In Treating Lung Disorders

    Tunde Otulana, M.D., heads Boehringer Ingelheim’s clinical development and medical affairs group. He is a former FDA reviewer who studied, learned, and finally got the chance to apply his knowledge of clinical trials when he stepped over into industry in 1997. As a pulmonologist who previously worked for about seven years in the FDA’s pulmonary division, Otulana subsequently led related R&D efforts at several companies before coming to BI in 2011. He now plays a key role in the U.S. in preserving the company’s position as a pioneer and leader in respiratory therapy, mainly in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

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FEATURED PRODUCTS

  • Bioprocess / Bulk Media Containers

    ASI provides a variety of low-cost fluid management systems for containment of bioprocessing and bulk media. The single-use and reusable liquid containers can be used for shipping and transport of liquids, in-plant containment, and storage.

  • Temperature Monitoring
    Temperature Monitoring

    In transit or storage, Marken ensures that your pharmaceuticals, biologicals, medical devices, and diagnostic equipment stay within proper temperature ranges at all times. Our temperature-monitoring services provide you with the assurance of knowing your product’s integrity is never jeopardized.

  • Analytical Development & Testing
    Analytical Development & Testing

    Therapure leverages its extensive experience and 10,600 ft2 (985 m2) of fully equipped analytical development and quality control testing space to create robust and reliable analytical methods.

  • Maximize Containment With The Task-Specific Workstation

    Flow Sciences's Task-specific workstations can meet the challenges and end user can experience with other laboratory workstations.

  • Commercial Supply Risk Mitigation & Regulatory Services
    Commercial Supply Risk Mitigation & Regulatory Services

    Patheon is a recognized innovator in risk mitigation and has many years of experience working with regulatory agencies around the world. Experience gained over thousands of projects gives Patheon can provide extensive documentation required and the ability to prevent problems before they occur.

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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...

  • DASGIP Information and Process Technology GmbH an Eppendorf company
    DASGIP Information and Process Technology GmbH an Eppendorf company

    Rapid technological advances in biotech and pharmaceutical industries have created increasing demands in research and development. DASGIP Parallel Bioreactor Systems for the cultivation of bacterial, phototrophic, animal and human cells at bench top scale support scientists and engineers to accomplish their projects quicker and more efficiently.

  • Patheon Inc.
    Patheon Inc.

    Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.

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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.

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 UPCOMING TRAINING COURSES

Identifying and Closing the Training Gap in Clinical Research

September 4, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training

CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
1pm-2:30pm EDT, Online Training

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training
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WEBINARS

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BIO EVENTS

Identifying and Closing the Training Gap in Clinical Research

September 4, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training

CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
1pm-2:30pm EDT, Online Training

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training
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