Crucell Terug naar discussie overzicht

Jan Tui

1. [verwijderd] 30 juli 2006 17:56

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   Het volgende bericht vond ik op drugresearcher.com,en slaat duidelijk op Crucell. Hiermede wordt nog eens duidelik hoe imposant de technieken zijn, waarover crucell beschikt. Het bevestigt ook nog eens , dat Crucell een lange termijn belegging is en dat u zich niet in de war moet laten brengen door allerlei op korte termijn denkende lieden.
   
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   Omnia Biologics seals TB vaccine production deal
   
   By Kirsty Barnes
   
   
   
   
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   26/07/2006 - Omnia Biologics has sealed a deal to help the Aeras Global TB Vaccine Foundation in its quest to make quantities of a new TB Vaccine that will “fulfil all the needs of the developing world.”
   
   Omnia is a biologics contract manufacturer offering services in the areas of process development, GMP manufacture and fill-finish for preclinical and Phase I clinical programs for therapeutics that do not have effective or known manufacturing protocols.
   Under the new deal, the firm will provide Aeras with vaccine process and production services in the development of a “promising new tuberculosis (TB) vaccine technology based on a validated platform,” said the firm.
   
   No other details were disclosed.
   
   Aeras is a non-profit organisation founded to help develop new vaccines to control and eliminate the global TB epidemic.
   
   Two billion people - one third of the world's population - have been infected with TB and it is the world's second deadliest infectious disease – killing two million people each year, primarily in the developing world.
   
   Aeras aims to develop at least one new TB vaccine within the next decade and in anticipation of success, has recently opened a new $10m (€7.9bn) laboratory and manufacturing facility, which it claims will be able to manufacture, in bulk, all of the developing world's needs for a new TB Vaccine.
   
   “Using advanced manufacturing technology and capable of producing 150m vaccine doses per year, the facility ensures rapid scale up of the production of new vaccines,” said the organisation.
   
   Aeras's vaccine-development programme, which began in 2004, is being funded by a five-year, $82.9m grant from the Bill and Melinda Gates Foundation.
   
   In 2004 Aeras also received a three-year, $2.7m grant from the US Centers for Disease Control and Prevention and in 2005 Danida, the Danish Government's development agency, also invested $785,000.
   
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2. [verwijderd] 30 juli 2006 18:10

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3. [verwijderd] 30 juli 2006 21:47

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   Larsnterry:
   
   Voor iemand die nog nooit gepost heeft, en dan zoiets op het forum zet beslist een aanbeveling waard. Blijf posten !
   
   Giraf
4. [verwijderd] 30 augustus 2006 13:44

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   quote:

   larsenterry schreef:

   .....,en slaat duidelijk op Crucell.
   

   Even een vraag: waarom?
   Overeenkomst Omnia/Aeras blijft mij nl. intrigeren, ik heb nog steeds geen bewijs kunnen vinden dat we hier spreken over PER.C6, jij wel?
   
   Even helemaal plakken uit de TB-draad:
   flosz - 26 jul 06, 21:46
   26/07/2006 - Omnia Biologics has sealed a deal to help the Aeras Global TB Vaccine Foundation in its quest to make quantities of a new TB Vaccine that will “fulfil all the needs of the developing world.”
   Omnia is a biologics contract manufacturer offering services in the areas of process development, GMP manufacture and fill-finish for preclinical and Phase I clinical programs for therapeutics that do not have effective or known manufacturing protocols.
   Under the new deal, the firm will provide Aeras with vaccine process and production services in the development of a “promising new tuberculosis (TB) vaccine technology based on a validated platform,” said the firm.
   No other details were disclosed.
   Aeras is a non-profit organisation founded to help develop new vaccines to control and eliminate the global TB epidemic.
   Two billion people - one third of the world's population - have been infected with TB and it is the world's second deadliest infectious disease – killing two million people each year, primarily in the developing world.
   Aeras aims to develop at least one new TB vaccine within the next decade and in anticipation of success, has recently opened a new $10m (€7.9bn) laboratory and manufacturing facility, which it claims will be able to manufacture, in bulk, all of the developing world's needs for a new TB Vaccine.
   “Using advanced manufacturing technology and capable of producing 150m vaccine doses per year, the facility ensures rapid scale up of the production of new vaccines,” said the organisation.
   Aeras's vaccine-development programme, which began in 2004, is being funded by a five-year, $82.9m grant from the Bill and Melinda Gates Foundation.
   In 2004 Aeras also received a three-year, $2.7m grant from the US Centers for Disease Control and Prevention and in 2005 Danida, the Danish Government's development agency, also invested $785,000.
   www.in-pharmatechnologist.com/news/ng...
   ************************
   wpw - 27 jul 06, 09:04
   Een spannend en geheimzinnig bericht.
   Waarvoor dank flosz.
   Crucell inside???
   ***************************
   maxen - 27 jul 06, 09:40
   Inderdaad zeer interessant....en daarom aanbevolen.
   Tal van verhulde verwijzingen naar Crucell naar mijn mening.
   Overigens, klik op "TB vaccine" en je krijgt meer nieuws uit hetzelfde magazine betreffende TB vaccins. Het voorlaatste artikel luidt:
   www.in-pharmatechnologist.com/news/ng...
   En beschrijft het bekende (zie dit draadje) 2005 nieuws:
   Crucell and Aeras announces (sic!) unique TB vaccine trials
   08/09/2005 - Dutch biotechnology company Crucell and the Aeras Global TB Vaccine Foundation has announced the initiation of a series of clinical studies for a unique TB vaccine, which allows millions of doses to be manufactured simultaneously while keeping costs relatively low.
   This is of utmost importance particularly in the case of poverty-related diseases such as HIV, malaria and TB. In approaching vaccine development in this way, the hope is that more people can be treated more effectively as well as more cheaply.
   The studies, which follow promising results for the vaccine obtained in animal studies, are scheduled to start in Europe, the US and Africa in the second quarter of 2006.
   The vaccine uses a combination of adenovirus serotype-35 (Ad35) and Crucell's PER.C6 production technology. The technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines.
   The strengths of the PER.C6 technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
   "We developed a vector system that is stable over enough passages to allow for the production of a large number of vaccine doses," commented Crucell's chief scientific officer, Dr Jaap Goudsmit.
   "It took us a substantial period of time to develop such a system for Ad35 vectors, particularly because our TB vaccine contains a combination of multiple antigens in a single vector," he added.
   AdVac technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and re-emerging infectious diseases and in biodefence.
   The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a 'vehicle' called a vector, which then delivers the immunogenic material directly to the immune system.
   Most vectors are based on an adenovirus, such as the virus that causes the common cold. The AdVac technology is designed to manage the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5.
   What is unique about the AdVac technology is that it is based on adenovirus vectors that do not regularly occur in the human population, such as Ad35.
   In contrast to the AdVac vectors, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines.
   There is an urgent need for a fast, cost-effective way to contain tuberculosis in order to treat and control this highly contagious bacterium that infects one-third of the world's population,
   The spread of TB has been most prevalent in developing countries where the rate of infection has been soaring. In the developing world, with poor infrastructure like roads and communications, even six months may be too long for the people located there.
   Another factor has been the HIV pandemic, which has increased the problem of TB in addition to HIV itself.
   *******************************
   maxen - 27 jul 06, 10:20
   Aan de andere kant:
   Al eerder gepost door Biocon:
   www.aeras.org/news/documents/Financia...
   Aeras schreef:...
   "We wanted to guarantee delivering to the developing world at the cheapest price and with the
   highest quality," said Jerry Sadoff, a veteran vaccine scientist previously at Merck, who now runs
   Aeras. "I think this is the first time a non-profit is taking a product in development and
   contemplating its manufacture and distribution."
   With an initial investment of $10m, the Aeras plant will cultivate the vaccine in fermenters in
   powdered form for reconstitution in countries at risk, with far less wastage and at a lower cost
   than the existing dispersed methods.
   ...
   
5. [verwijderd] 30 augustus 2006 13:45

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   Vervolg.
   
   Al eerder gepost door BioStefan:
   Biostefan schreef:
   Aeras is working on newer technology using Shigella, a bacteria that causes diarrhea. The new vaccine weakens Shigella so it does not cause illness, but instead delivers a tiny nanoparticle containing genetic material from M. tuberculosis. Like BCG, it would be an oral vaccine, Sadoff said.
   Dit is dus een vaccin gemaakt van een gemodificeerde Shigella bacterie met stukjes DNA van de tbc bacterie. Deze technologie is vergelijkbaar met Crucell's vaccines op basis van een Adenovirus met een ingebouwd stukje DNA van een kwalijk virus.
   Deze door Aeras zelf ontwikkelde techniek is dus geen Per.C6-gebaseerd vaccin.
   Het zou kunnen dat de hardware in de nieuwe Aeras faciliteit specifiek geschikt is voor het kweken van deze bacterien, en niet voor (Per.C6) cellen...
   En dat de verwijzing in het persbericht van Omnia naar de "veelbelovende nieuwe TB vaccin technologie gebaseerd op een gevalideerd platform" naar deze Shigella techniek verwijst.
   (Maar vooral "gevalideerd platform" vindt ik nog steeds erg Per-C6-ig klinken....)
   *******************
   maxen - 27 jul 06, 10:41
   Dit verklaart grotendeels waarom Aeras voor Omnia kiest in de productie-begeleiding: ons kent ons in Rockville...en lekker handig dichtbij.
   washington.bizjournals.com/washington...
   Omnia Biologics signs service agreement with Aeras
   Biologics contract manufacturer Omnia Biologics has a new agreement with the Aeras Global TB Vaccine Foundation to provide Aeras with vaccine process and production services.
   Rockville-based Omnia is a provider of customized manufacturing services for the development of vaccines, gene-based drugs and biodefense products. Aeras, also of Rockville, is attempting to develop one or more new vaccines against tuberculosis.
   Aeras, a nonprofit organization, would like to develop at least one new vaccine within the next decade.
   Founded in 1997, Aeras received a five-year, $82.9 million grant from the Bill & Melinda Gates Foundation in 2004 for TB vaccine development. More recently, it got funding from the Centers for Disease Control and Prevention and the government of Denmark.
   Aeras also has a new $10 million lab and manufacturing facility in Rockville, which will be able to manufacture, in bulk, all of the developing world's needs for a new TB vaccine.
   "Aeras' strategy to develop a vaccine based on well validated and well understood technology greatly enhances the immediacy of their impact on this seemingly intractable disease," says Dale VanderPutten, CEO of Omnia, in a statement.
   "We ... are thrilled to be asked to assist Aeras in this important work."
   ***********************
   maxen - 27 jul 06, 10:49
   Dit is wel weer leuk, van de Omnia website:
   "Omnia Biologics, Inc. ("Omnia") provides customized manufacturing and process development solutions for the development of vaccines, gene therapeutics, and biodefense products."
   Wat voor services verleent Omnia precies?
   Specifiek in process development?
   www.omniabiologics.com/Process_Dev.html
   Omnia schreef:
   Capabilities
   Process Design and Development
   - Media
   - Cell line
   - Cell culture process
   - Purification
   - Analytical and process scale-up
   Cell line? Cell culture process? Mmm...
   www.iex.nl/forum/topic.asp?forum=228&...
   www.iex.nl/forum/topic.asp?forum=228&...
6. [verwijderd] 30 augustus 2006 16:56

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   So they still treat us like mushrooms:
   
   Keep them in the dark and give them shit!!
7. [verwijderd] 30 augustus 2006 20:06

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   Met alle respect maar ik geloof niet dat dit over het Crucell programma gaat.
   Ten eerste is het niet logisch dat een derde partij zonder enige ervaring (althans niet na te trekken) dit gaat produceren.
   Ten tweede is het PER.C6 platform mijn inziens absoluut nog niet een "validated platform". En last but not least... als die trials nog dit jaar moeten starten zouden die batches al lang geproduceerd moeten zijn. Voordat de trials kunnen beginnen gaat er nog een vrij lang proces van kwaliteitscontrole aan vooraf. Als die gasten in juli nog moesten beginnen met het ontwerp van het productieproces dan was het niet best.
   
   Op basis hiervan ben ik ff verder gaan zoeken en vond ik deze aardige presentatie.
   www.tballiance.org/downloads/reverset...
   zie ook plaatje als bijlage
   
   Ook deze slide suggereert dat de klinische trials elk moment kunnen starten (presentatie dateert van maart 2006)
   
   Stefan

   Bijlage:
8. [verwijderd] 30 augustus 2006 20:34

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   quote:

   BioStefan schreef:

   Op basis hiervan ben ik ff verder gaan zoeken en vond ik deze aardige presentatie.
   www.tballiance.org/downloads/reverset...
   zie ook plaatje als bijlage
   
   Ook deze slide suggereert dat de klinische trials elk moment kunnen starten (presentatie dateert van maart 2006)
   
   Stefan
   

   Goed gevonden Stefan.
   Zelfde plaatje bijgevoegd, hopenlijk wat kleiner.

   Bijlage: