FEATURED ARTICLES

  • 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)

More Featured Articles

BIORESEARCH INSIGHT

  • 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.

More From bio insight homepg bucket

FEATURED PRODUCTS

  • viewLinc Continuous Monitoring System (CMS): Monitoring, Alarming & Reporting Software
    viewLinc Continuous Monitoring System (CMS): Monitoring, Alarming & Reporting Software

    As part of the Vaisala Veriteq Continuous Monitoring System (CMS) viewLinc software provides alarming, real-time trending, and 21 CFR Part 11-compliant records for critical parameters in life science environments. With industry-best data loggers  viewLinc monitors temperature, relative humidity, CO2, differential pressure, level, door switches, and more.

  • Fluid Control Systems For Sterilizers And Washers
    Fluid Control Systems For Sterilizers And Washers

    Infection protection is a rapidly growing industry where sterility and reliability are crucial.

  • Sterilizing Grade Filters
    Sterilizing Grade Filters Sterilizing Grade Filters of different membrane materials and pore size combinations for sterilizing grade filtration to remove viable microorganisms from the liquid or gas stream.
  • IOL Series Filter Housings
    IOL Series Filter Housings Pall IOL and IDL Single-round Housings are constructed of stainless steel and are designed for industrial applications (such as filtration of fluids in utilities areas).
  • Cargo Companion Tracking Solution
    Cargo Companion Tracking Solution

    The commercial air cargo industry’s most comprehensive tracking solution provides location and temperature information for your time-critical, high value and temperature sensitive cargo.

More Products

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.
More Videos

FEATURED SUPPLIERS

  • Envirotainer
    Envirotainer

    We are a global market leading provider of an air cargo cold chain transportation concept to pharmaceutical companies and their logistics partners. We are unique and the benchmark for global air cargo cold chain management and logistics solutions.

  • ISPE
    ISPE

    ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle.

  • 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.

More Suppliers....

BIORESEARCH ONLINE INDUSTRY PARTNERS

 

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.

Please take a moment to join our community and discover the benefits of your free membership.

 

Newsletter Signup
Newsletter Signup

 UPCOMING TRAINING COURSES

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
More Upcoming Courses

WEBINARS

  • 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.

More Life Science Webinars

BIO EVENTS

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
More Events....

NORTHERN CALIFORNIA’S LIFE SCIENCE ASSOCIATION

feed image
more BayBio events...