Pharming Group NL0010391025

Gottlieb: 'Enormous Investment' Needed For New Flu Vaccine Technology

1. [verwijderd] 10 maart 2018 12:03

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   March 09, 2018
   A fundamental change in manufacturing would be needed for the United States to shift from “antiquated” egg-based flu vaccines to newer technologies like cell-based vaccines and recombinant DNA technology, which could pave the way toward a universal vaccine, government experts told lawmakers March 8. But investing in continuous manufacturing can help usher along this shift, FDA Commissioner Scott Gottlieb argued.
   
   www.fda.gov/NewsEvents/Newsroom/Press...
   
   - - -
   www.pharming.com/rnd/transgenic-produ...
   
   After the discovery of DNA and recombinant DNA techniques in the past decades it became possible to transfer genes between different organisms, such as plants and bacteria. Scientists discovered how to transfer mammalian genes into the genetic material of other animals, and breed transgenic animals with specific (mixed) characteristics. This new scientific approach of recombining genetic material from different biological sources became known as recombinant DNA technology and the animals generated with such technology as transgenic animals.
   
   - -
   Denk dat Pharming met hun TPT Platform nu bij velen op de radar komt te staan..
2. Capstone 10 maart 2018 12:07

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   Goed verhaal
3. posilies 10 maart 2018 12:12

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   Zoveel meer dan Ruconest alleen!
4. [verwijderd] 10 maart 2018 12:14

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   ..Continuous manufacturing holds great promise for both cell-based and recombinant vaccines, because supply could be more easily ramped up on short notice.
   
   dubbeltje begint langzaam aan te vallen..
5. [verwijderd] 12 maart 2018 12:35

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   Recombinant proteins
   
   Protein is an important component of all organisms. Each protein molecule consists of one or more polypeptide chains made of amino acids. There are 20 naturally occurring amino acids. Different series of amino acids are linked together by peptide bonds to form protein chains. Each protein has a unique sequence of amino acids. All the functions of proteins are dependent on their structures. Although information necessary for life is encoded by DNA or RNA, proteins perform a wide range of biological functions within organisms, including enzyme catalysis, defense, transport, support, motion, and regulation. According to their functions in the body, proteins can be divided into different categories, such as antibody, enzyme, messager, structural component, and transport/ storage protein. Given the important functions of proteins, proteins have been studied intensively and applied widely.
   
   In the past, the major way to obtain a specific protein was to isolate it from a natural source, which is generally inefficient and time-consuming. Recent advances in recombinant molecule biological techniques have made it possible to clone the DNA encoding a specific protein into an expression vector and express the protein in expression systems, such as bacteria, yeast, insect cells, and mammalian cells. Simply put, recombinant proteins are translated products of exogenous DNA in living cells. The production of recombinant proteins generally contains two major steps: molecule cloning and protein expression. Currently, recombinant protein production is one of the most powerful techniques used in life sciences. Recombinant proteins have wide applications in medicine, research, and biotechnology.
   
   1. Medicine
   Therapeutic proteins provide important therapies for a variety of diseases, such as diabetes, cancer, infectious diseases, hemophilia, and anemia. Common therapeutic proteins include antibodies, FC fusion proteins, hormones, interleukins, enzymes, and anticoagulants. There is a growing demand for recombinant proteins for therapeutic applications. Human proteins obtained through genetic engineering play a key role in therapeutic medicines market. Currently, most of all recombinant therapeutic proteins are produced in mammalian cells because mammalian cells are capable of producing high-quality proteins similar to the naturally occurring ones. In addition, many approved recombinant therapeutic proteins are generated in Escherichia coli due to its well-characterized genetics, rapid growth, and high-yield production.
   
   Basically, therapeutic proteins can be classified into four groups.
   
   Group I: Therapeutic proteins with enzymatic or regulatory activity. These proteins replace a protein that is deficient or abnormal, up-regulate an existing pathway, or provide a new function or activity.
   
   Group II: Therapeutic proteins with special targeting activity. These proteins interfere with a molecule or organism or deliver other molecules.
   
   Group III: Therapeutic proteins as vaccines. These proteins help protect against foreign agents, autoimmune diseases, and cancer.
   
   Group IV: Therapeutic proteins as diagnostics. These proteins are generally purified and recombinant proteins.
   
   2. Research
   Recombinant proteins help to elucidate the basic and fundamental principles of an organism. These molecules can be used to identify and locate the position of the protein encoded by a specific gene, and to uncover the function of other genes in various cellular activities such as cell signaling, metabolism, growth, replication and death, transcription, translation, and protein modification. Thus, recombinant proteins are frequently used in molecular biology, cell biology, biochemistry, structural and biophysical studies, and many other research fields.
   
   Recombinant proteins are useful tools in understanding protein-protein interactions. They have proven performance in several laboratory techniques, such as ELISA, Western Blot, and immunohistochemistry (IHC). Recombinant proteins can be used to develop enzymatic assays. When used in conjunction with a matched antibody pair, recombinant proteins can be used as standards such as ELISA standards. Moreover, recombinant proteins can be used as positive controls in Western blots.
   
   3. Biotechnology
   Recombinant proteins are also used in industry, food production, agriculture, and bioengineering. For example, in breeding industry, enzymes can be added to animal feed to increase the nutritional value of feed ingredients, reduce feed and waste management costs, support animal gut health, enhance animal performance and improve the environment. Besides, lactic acid bacteria (LAB) have been used for a long time for the production of fermented foods, and recently, LAB has been engineered for the expression of recombinant proteins, which have wide applications such as improving human/animal digestion and nutrition.
6. [verwijderd] 12 maart 2018 12:37

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   ..Recombinant proteins are useful tools in understanding protein-protein interactions. They have proven performance in several laboratory techniques, such as ELISA, Western Blot, and immunohistochemistry (IHC)
   
   Gert Jan Stam - Research Associate Analytical Development | LinkedIn
   
   Amsterdam en omgeving, Nederland - ?Research Associate Analytical Development - ?Pharming Group N.V.
   Research Associate Analytical Development at Pharming Group N.V. ... Specialties: Western blotting. ELISA RT-qPCR qPCR. Writing development reports. Writing standard procedures. Lab and supply management. Works council. GMP ... Developing, qualifying and trouble shooting assays (e.a. ELISA, Activity assays)
7. [verwijderd] 5 april 2018 12:43

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   "The ultimate goal is to go to recombinant DNA technology"
   
   NIH Scientist Expects Universal Flu Vaccine in 5 Years
   But only version 1.0 -- a really effective product 'is many years out'
   
   www.medpagetoday.com/infectiousdiseas...
   
   ( TPT Platform...)
8. Sursum 5 april 2018 13:34

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   quote:

   beeldscherm schreef op 5 april 2018 12:43:

   "The ultimate goal is to go to recombinant DNA technology"
   
   NIH Scientist Expects Universal Flu Vaccine in 5 Years
   But only version 1.0 -- a really effective product 'is many years out'
   
   www.medpagetoday.com/infectiousdiseas...
   
   ( TPT Platform...)
   

   Interessant stukje. Maar ook de reactie en de link van Vinu Arumugham daarop (Short sighted influenza control policy based on poorly designed vaccines will sicken more people). Voordat dit zover is volgen er vast nog heel wat discussies!
   
   
9. [verwijderd] 5 april 2018 13:49

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   quote:

   Sursum schreef op 5 april 2018 13:34:

   [...]
   
   Interessant stukje. Maar ook de reactie en de link van Vinu Arumugham daarop (Short sighted influenza control policy based on poorly designed vaccines will sicken more people). Voordat dit zover is volgen er vast nog heel wat discussies!
   
   

   klopt, maar er is "reuring" op het recombinant dna vlak/platformen...
10. [verwijderd] 23 mei 2018 14:03

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    FDA chief Gottlieb is building a regulatory speedway to accelerate gene therapy development.
    
    In a rallying cry for gene therapy, FDA Commissioner Scott Gottlieb says he’s determined to clear the pathway for drug developers in a move to accelerate the first wave of gene therapies pointed to the market.
    
    The first therapeutic area to benefit from new surrogate endpoints will be hemophilia, Gottlieb said
    
    endpts.com/fda-chief-gottlieb-is-buil...
    - -
    rhFVIII (Factor VIII)
    Factor VIII (rhFVIII)
    Haemophilia A is an X chromosome linked hereditary disorder caused by defects in the Factor VIII (FVIII) gene that lead to lower levels of the functional FVIII protein. Lack of functional FVIII diminishes the body’s clotting ability, which in turn can lead to damaging or fatal bleeding episodes.
    
    Recombinant human Factor VIII is a natural human blood clotting factor and is in early-stage development for treatment of Haemophilia A. Haemophilia A is a hereditary disorder caused by defects in the Factor VIII gene. Lack of functional Factor VIII diminishes the body’s clotting ability, which in turn can lead to damaging- or fatal bleeding episodes.
    ..
    Under the terms of the agreement, Pharming will transfer the Pharming technology platform and manufacturing know- how to SIPI, such that joint global development for new products will take place at SIPI’s facilities in Shanghai and benefit from both the cost advantages of the Pharming platform and the competitive development and manufacturing costs structures at SIPI.
    
    The first projects to be jointly developed and manufactured at SIPI will be recombinant C1-inhibitor (conestat alfa) and Factor VIII.
11. [verwijderd] 3 juni 2018 11:13

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    Nu ga ik een Bolt-statement maken,op 21 june zal FDA baas Scott Gottlieb m.i ook aanwezig zijn (daarom ook in de US) als je onderstaand stuk eens diep op je laat inwerken/begrijpt..
    
    www.fda.gov/NewsEvents/Speeches/ucm60...
    
    alleen dit stukje al geeft te denken,
    
    The first therapeutic area we’ll focus on is hemophilia, where factor production may be sufficient in some cases as a surrogate measure of benefit where a gene therapy product can potentially normalize factor production.
    
    In these settings, the demonstration of a reduction in bleeding rates could be confirmed post approval, as we continue to study a product’s long-term safety and durability. The other guidance documents that we’ll release will deal with specific manufacturing and clinical issues related to gene therapy products.
    
    By providing clarity to developers on manufacturing parameters, safety measures, and the pathway toward clinical development, the FDA hopes to foster even greater innovative development in this field. Once these draft guidance documents are released, we’ll look forward to your comments on them. We value the benefit of input from informed stakeholders such as the Alliance for Regenerative Medicine.
    
    The challenges we see, related to gene therapy products, are the sort of questions that we can help resolve by working together. Though gene therapies have the potential to address both common and rare diseases, currently they hold out tremendous hope in our country -- especially for those with the more than 7,000 different rare diseases. The challenges in developing products for such rare diseases that may affect anywhere from less than a hundred people -- to tens of thousands of individuals -- are apparent to all of us at the FDA.
    
    shoot me!
12. [verwijderd] 3 juni 2018 14:13

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    cellculturedish.com/2018/03/cell-ther...
    
    Cell Therapy Manufacturing – Opportunities and Challenges
    
    luister naar de audio vanaf min.3 en dan vanaf 15.40
    
    over de verandering van "cocktail making platforms" naar na mijn mening, Pharmings platform die infeite nog niet bestaan, hij benoemt het ff anders,
13. [verwijderd] 3 juni 2018 14:39

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    quote:

    beeldscherm schreef op 3 juni 2018 14:13:

    cellculturedish.com/2018/03/cell-ther...
    
    Cell Therapy Manufacturing – Opportunities and Challenges
    
    luister naar de audio vanaf min.3 en dan vanaf 15.40
    
    over de verandering van "cocktail making platforms" naar na mijn mening, Pharmings platform die infeite nog niet bestaan, hij benoemt het ff anders,
    

    Dank je! Ik was al wel overtuigd van de waarde van het transgene platform. Dat is precies de reden waarom ik LT zit. Ik hoop idd. ook dat dat kwartje ook bij anderen begint te vallen ;-)
    
    
14. Casper4711 3 juni 2018 14:59

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    In 2011 was er al belangstelling voor het platform.
    
    www.rtlnieuws.nl/economie/pharming-me...
15. [verwijderd] 3 juni 2018 15:04

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    quote:

    LT belegger schreef op 3 juni 2018 14:39:

    [...]
    
    Dank je! Ik was al wel overtuigd van de waarde van het transgene platform. Dat is precies de reden waarom ik LT zit. Ik hoop idd. ook dat dat kwartje ook bij anderen begint te vallen ;-)
    
    

    Ceo Sijmen de Vries van Pharming:
    Volgens hem kan een bedrijf als Pharming zelfstandig veel meer maken en betekenen voor de ontwikkeling van nieuwe geneesmiddelen.
    En hoe meer- waarde je creëert.... dat doen we liever zelf.
    Pharming is deze woorden ook aan omzetten in daden en is LT gewoon een prima beslissing.
16. [verwijderd] 16 augustus 2018 09:49

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    U.S. officials removing special rules for gene therapy experiments.
    
    www.ctvnews.ca/health/u-s-officials-r...
    
    ..It’s time to let the FDA review gene therapy proposals on its own without duplicating regulatory efforts, the NIH’s director, Dr. Francis Collins, and FDA chief Dr. Scott Gottlieb wrote Wednesday in the New England Journal of Medicine. The proposed changes will go into effect after a public comment period.