• Influence Of Silanol Content, Humidity And Temperature On Efficacy Of A Silica Based Carrier
    Influence Of Silanol Content, Humidity And Temperature On Efficacy Of A Silica Based Carrier

    Recently, silica based carriers have been widely used for the adsorption of oily and lipid based formulations. Using silica as adsorbent, liquid self emulsifying drug delivery systems could be formulated in tablet or capsule oral dosage form. For this application, an ideal carrier is one which possesses high adsorption capacity and immediate desorption or release at desired site. Three different types of carriers like Granulated fumed silica (GFS) Syloid® XDP-Mesoporous silica gel (MSG) and Magnesium aluminum silicate (MAS) were selected for this study. By Yogesh Choudhari, Upendra Reddy, and Fred Monsuur, Grace

  • Using Spray Drying For Flu Vaccines: What Challenges Do We Need To Overcome?
    Using Spray Drying For Flu Vaccines: What Challenges Do We Need To Overcome?

    When discussing the challenges of manufacturing flu vaccines, the conversation often shifts toward how manufacturers can meet the global demand each year. Currently there are some very innovative technologies aimed at addressing the challenge of manufacturing a larger supply of flu vaccines in a shorter amount of time, such as Novartis’ use of cell culture and Medicago and Fraunhofer’s use of tobacco plants. However, being able to deliver enough of a vaccine is only half the battle. It also needs to be delivered to its final destination within the appropriate temperature range. “It’s a huge misnomer for people who believe these technologies will unconstraint flu,” says Jim Robinson, VP of global technical operations, biological, and sterile products at Merck, who was involved in the manufacturing of billions of doses of flu vaccine prior to joining Merck. “The product still needs to get into a usable form and be delivered safely to the patient.”

  • BDP Week Highlights The Importance Of Communication In BioPharma
    BDP Week Highlights The Importance Of Communication In BioPharma

    At this year’s Biopharmaceutical Development and Production (BDP) Week, March 24-27 at the Hilton Bayfront Hotel, I attended several sessions that focused on how to strengthen the relationship between partners in the pharmaceutical industry. One overwhelming theme in each presentation was the importance of communicating effectively and clearly with everyone involved in a project.

  • Time Is Money, So Spend It Wisely
    Time Is Money, So Spend It Wisely

    In a traditional office environment, hours upon hours are often spent collaborating with other people to come up with game-changing ideas. Even the time spent alone at your desk can be occupied with juggling multiple responsibilities and tasks. It’s usually only during downtime at the end of the day, whether it’s a quiet ride home in the car or lying in bed at night, that we allow ourselves time to relax and reflect. Tony and Oliver Stauffer, president and chief operating officer at Packaging Technology & Inspections, as well as father and son, believe it’s during these moments to ourselves that we have the ability to come up with some of our best ideas.

  • The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
    The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together

    The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization. The warning letter stated in part:

    “In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this CGMP violation. You are responsible for ensuring that the test methods used by your firm are validated.” (Emphasis added)

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  • Hygienic Processing: Elimination Of Dead Space Volume

    Hygienic processing places high demands on the reliability and cleanability of production facilities. These requirements are especially high in separation processes like filtration and chromatography and are significant in ensuring purity of media by maintaining sterile process conditions.

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  • Mobile Refrigeration / Freezer Unit: Acutemp AX27L
    Mobile Refrigeration / Freezer Unit: Acutemp AX27L

    AcuTemp mobile refrigerator / freezers are designed to safely and reliably store or transport temperature sensitive goods such as biologics, vaccines and pharmaceuticals. With payload sizes available in 27 liters and 56 liters, these versatile, thermal management units are ideally suited for the cold chain needs of hospitals, public health operations, first responders, disaster preparedness, military medical units and laboratory and research facilities.

  • Buffer / Media Filtration
    Buffer / Media Filtration

    LifeASSURE PNA series filters help bioprocess, pharmaceutical, biologicals, and diagnostic reagent processors meet high standards for microorganism and fine particle control. 

  • Films

    Thermo Scientific* produces a wide range of optical and electro-optical, multi-layer inorganic coatings on a variety of substrates. Our advanced thin films include materials such as gold and other metallic coatings.

  • Fluid Control Systems For Fermentation Systems
    Fluid Control Systems For Fermentation Systems

    Since prehistoric times humans have been taking control of the fermentation process. From Pasteur to Buchner to the Carlsberg scientists, the conversion of juice into wine, grains into beer, milk to yogurt, carbohydrates into carbon dioxide to raise bread, and sugars in vegetables into preservative organic acids.

  • HPLC Columns
    HPLC Columns

    Hamilton Company has been developing and manufacturing pressure-stable polymeric high performance liquid chromatography (HPLC) columns for nearly 35 years. Hamilton was one of the first companies to understand the unique qualities of polymerbased columns and how the technology could advance the field of HPLC. Following significant research and advancements by its team of engineers and scientists, Hamilton’s first line of pressure-stable polymeric HPLC columns was created, making it a pioneer in the development and manufacturing of polystyrene-divinylbenzene (PS-DVB) polymers for HPLC applications. We are an established name in science whose products are found in most of the world’s top chromatography labs. From columns to syringes to septa and more, Hamilton Company offers a full line of off-the-shelf and custom chromatography products for HPLC, gas chromatography (GC) and thin layer chromatography (TLC).

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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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  • Parker domnick hunter Process Filtration
    Parker domnick hunter Process Filtration

    As the life science market continues to face challenges with the processing of high value and often fragile products, Parker domnick hunter brings fresh choice and new solutions to meet the filtration and processing needs of the industry.

  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

  • Grace

    Grace is a global provider of process manufacturing solutions supporting pharmaceutical and biotech industries. Our range of solutions includes peptide building blocks for API synthesis, chromatographic media and packing equipment for process purification, and multifunctional silica excipients for pharmaceutical formulation.

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Building Accountability on Your Clinical Teams

April 29, 2014
1pm-2:30pm EDT, Online Training

Root Cause Analysis for Clinical Research Professionals

May 5, 2014
1pm-3pm EDT, Online Training
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  • H.R. 3204 Drug Quality And Security Act
    H.R. 3204 Drug Quality And Security Act

    After so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.


  • PAT-Enabled Process Optimization & Control

    PAT is a risk-based strategy for designing, analyzing and controlling manufacturing processes. The Critical Process Parameters (CPPs) are identified in line with the definition of the Critical Quality Attributes (CQAs) of intermediates or final products. PAT offers a number of tools for measuring and controlling these CPPs.
    Sartorius has the right choice of solutions you need: discover our world of Synchronized PAT Solutions.

  • Adoption of Membrane Chromatography in the Vaccine Industry
    Adoption of Membrane Chromatography in the Vaccine Industry

    This educational webinar will discuss a high throughput process development (HTPD) approach using Mustang® membrane to define the optimal operating conditions resulting in the best quality of the virus product and demonstrate the predictive power of this methodology as applied to the purification of influenza virus.

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Stem Cell Summit 2014

April 24 - 25, 2014
Boston, MA

Building Accountability on Your Clinical Teams

April 29, 2014
1pm-2:30pm EDT, Online Training
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