Showing all blog posts for 'manufacturing' back to blog
  • Themis Bioscience Receives FDA Fast Track Designation for Chikungunya Vaccine Candidate
    • posted by: Lee Smith
    • posted on: February 25, 2019

    Chikungunya Vaccine receives FDA Fast Track Designation

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  • Themis Bioscience Enters into a $37.5m Agreement with CEPI to Develop a Lassa Fever and MERS-CoV Vaccine
    • posted by: Lee Smith
    • posted on: March 7, 2018

    Themis Bioscience GmbH, an Austrian based vaccine company, has secured a $37.5m agreement with CEPI to create new vaccines for the infectious diseases Lassa Fever and MERS-CoV.

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  • Bioprocess International Article on Ensuring and Controlling the Quality of Biologics
    • posted by: Lee Smith
    • posted on: June 30, 2017

    Article titled The State of the Industry as a celebration of BioProcess International’s 15th year of publication

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  • Takeda have finished enrolling 20,100 children for their phase 3 dengue vaccine.
    • posted by: Lee Smith
    • posted on: April 25, 2017

    Takeda has recently finished enrolling 20,100 children for their phase 3 dengue vaccine clinical study in 8 endemic countries after just seven months. The study, that was started back in September 2016, is a placebo controlled study covering two doses of the vaccine each three months apart in children aged from 4 to 16. The aim is to confirm if the vaccine can protect against any dengue serotype of varying severities regardless of previous exposure.

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  • Zika Vaccines Ready for Testing
    • posted by: Lee Smith
    • posted on: March 28, 2017

    Several vaccines for Zika virus including a traditional inactivated virus vaccine, as well as newer DNA vaccines have passed animal tests and are now ready for human trials.

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  • CEPI Vaccine Fund
    • posted by: Lee Smith
    • posted on: January 30, 2017

    Last October (2016) I posted an article on whether there should be a global vaccine development fund. Therefore, I was very excited to see an announcement made at the World Economic Forum in Davos, Switzerland on January 18th (2017) that a new global coalition had been formed; the Coalition of Epidemic Preparedness Innovations, or CEPI.

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  • Small Biotech & their Contract Manufacturing Organisation Partners
    • posted by: Lee Smith
    • posted on: November 15, 2016

    I’ve been working closely with contract manufacturing organisations (CMOs) for many years now.  Some of these have been in the USA, some in Europe and some in Asia.  What they have in common is that all have been a vital component in the development and manufacturing strategy of the organisations that I’ve been working for.   Unsurprisingly, I was generally working with a small and mid-size biopharmaceutical entity (SME) rather than multinational pharma that often have the resources to perform their own manufacturing or testing whereas the smaller companies do not.   If you look at the numbers relating to CMO use in the United States, almost 80% of products approved by the FDA will have been manufactured by a CMO on behalf of a SMEs. This drops to approximately 50% for mid-sized companies.

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  • Should there be a Global Vaccine Development Fund?
    • posted by: Lee Smith
    • posted on: October 25, 2016

    I recently attended the World Vaccine Congress in Barcelona. I joined a round table discussion hosted by Dr. Greg Poland from the Mayo clinic where the question asked was ‘should there be a vaccine development fund?’ The thrust of the discussion was based upon a publication that was made in the New England Journal of Medicine last year about Establishing a Global Vaccine-Development Fund. Vaccine funding is a complex question. Vaccines are probably one of the better value, if not the best, medicinal investments in that they focus on disease prevention rather than treating the consequential symptoms of the disease. Therefore, we might say from a public health economics perspective that vaccines make a lot of sense. But is that true?

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  • Meet GRA at the World Vaccine Congress, Barcelona
    • posted by: Lee Smith
    • posted on: October 5, 2016

    Dr. Lee Smith from GRA will be attending the World Vaccine Congress 2016 in Barcelona from the 10-12 October. The conference will be held at the Fairmont Rey Juan Carlos hotel. Hope to see you there!

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