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Coronavirus vaccine candidates

  • 1.  Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 13 days ago
    There has been some prolific research been carried out in this area by major pharmaceuticals across the globe and some potential candidates have been proposed which could function as viable vaccines for the coronavirus infection..
    However this is not an immediate solution and could take around 12 to 16 months for finalization, regulatory approvals and mass production. At the moment focus is primarily on developing antiviral therapies which could arrest the spread of this contagion and bring relief to the infected public. Some candidates like chloroquinone and remdesivir have been identified, but there could be some more.
    I am trying to gain more information on this interesting and highly sensitive topic.
    Any additional information/development is welcome..

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    Rohit Korde MSc,CEng
    Program Manager
    Worley
    Thane (W)
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  • 2.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 13 days ago
    I've also read of lopinavir being combined with remdesivir


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    Steve Cutchen
    Investigator, retired
    US Chemical Safety Board
    Houston TX
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  • 3.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 12 days ago
    We all should take heart that the rapid developments in Single Use Technology will help in significant reduction in time to production in vaccine(s) based on Cell Culture Technology. Pl see: https://onlinelibrary.wiley.com/doi/abs/10.1002/0471238961.koe00046
    I am sure that molecular biologists and chemical engineering teams will be able to develop not only vaccine(s) but also the the treatment regime.

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    Vishwas Pangarkar PhD
    Retired Professor of Chemical Engineering, University of Mumbai, India.
    Currently: Independent Chemical Engineering Academic/Professional.
    Nasik-422013, India.
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  • 4.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 12 days ago
    Single use reactor technologies have been in use in biotechnology industries for quite some time, to address primarily scale-up challenges and for capacity increase. Organic synthesis in pharmaceuticals have a different scale-up challenge than bio-technology. Bacteria worlds cannot be just increased in capacity & size. However, SS reactors with advanced reactor technologies are now brought into this world of bacteria too, esp. moving from batch to a continuous one.
    Different separation & intensification at reactor level are in current use to address such scale-up challenges. One key area is cellular proteins and applications including vaccines at manufacturing scale.
    Single use technology alone cannot be an impediment to proteins applications & vaccines manufacture. In an emerging country like India where single use plastic is a matter of grave environmental concern, single use plastic based reactor technologies without knowing how to address their disposition can create major environmental challenges.
    One of my current technology transfer project with European Research consortium is addressing this use of bio-plastics through industrial biotechnology in further downstream applications-from plastics to materials, from nylon to industrial products. I have seen German automobile companies using bio-plastics from steering wheel to body parts. Bio-plastics is green & biodegradable allowing mother nature to finish off the recycling back to nature .

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    Eur Ing (FEANI) Santanu Talukdar CEng (UK) CSci (UK) MIChemE SMAIChE
    Chartered Chemical Engineer
    Independent industry consultant-
    Innovations Mgmt & Technology Transfers
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  • 5.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 11 days ago
    I believe that I have been misunderstood/misquoted.
    1) Yes, there is a very fundamental difference between cell culture technology and chemical reactions. Whereas the cells will die if O2/nutrient supply is disrupted, the same cannot be said about say a hydrogenation reaction if the H2 supply is disrupted.
    2) Yes, SS reactors were the standards in the cell culture industry in the last decade, nobody is denying that. However, because of various reasons Single Use Technology (SUT) (combined with Perfusion) is getting industry approval. I would again cite the reference that I have quoted in my first post: https://onlinelibrary.wiley.com/doi/abs/10.1002/0471238961.koe00046.
    The following papers/bulletins should give an idea of the evolution and current trends in SUT:
    Bonham-Carter J, Shevitz J. A brief history of perfusion biomanufacturing. BioProcess Int. 2011 Oct;9(9):24-30.
    Langer ES, Rader RA. Single‐use technologies in biopharmaceutical manufacturing: A 10‐year review of trends and the future. Engineering in Life Sciences. 2014 May;14(3):238-43.
    Eibl, R. and Eibl, D. eds., 2011. Single-use technology in biopharmaceutical manufacture (pp. 3-11). New Jersey:: John Wiley & Sons.
    C. A. Challener, Biopharm. Int.;Single-use Bioreactors Have Reached the Big Time: 30(3), 18–23 (2017).
    Gao Y, Allison N. Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry. Journal of Chemical Technology & Biotechnology. 2016 Feb;91(2):289-95.
    Kwok CK, Ueda Y, Kadari A, Günther K, Ergün S, Heron A, Schnitzler AC, Rook M, Edenhofer F. Scalable stirred suspension culture for the generation of billions of human induced pluripotent stem cells using single‐use bioreactors. Journal of tissue engineering and regenerative medicine. 2018 Feb;12(2):e1076-87.
    GE Healthcare Life Sciences, Biologic Manufacturing Capacity Expansion with
    Single-Use Technologies, 2017, https://www.bioprocessonline.com/doc/biologicmanufacturing-
    capacity-expansion-with-single-use-technologies-key-variables-toconsider-0001
    Olsen, Matthew. "The Future of Single-Use Components in Biopharmaceutical Production. Chem Engg Progr," (July 2019): 41-46.
    3) Re: Disposal of single use components: The industry has made a decision considering this issue also. On the other hand there may still be concerns about "Leachables & Extractables" rather than disposal.
    I trust that I have made myself clear.



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    Vishwas Pangarkar PhD
    Retired Professor of Chemical Engineering, University of Mumbai, India.
    Currently: Independent Chemical Engineering Academic/Professional.
    Nasik-422013, India.
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  • 6.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 12 days ago
    My general observation & comments on Covid-19:

    1. Virus is a natural phenomena in all living species and are at a constant mutation & adaption in changing environmental concerns.
    2. All living beings will have a natural antibody developed depending upon the strength of their own immune system to fight against new virus influx.
    3. The question today is not about the virus, in my understanding, but largely the environmental damage caused by one living species in this planet earth. We the homo sapiens.
    4. If we feel, we own this planet and can cause all damages with impunity, then very well go ahead.
    5. Face the consequences. This is just the beginning. If bats, monkeys , wild animals, bees & birds, fishes and wales are uprooted from their natural habitat, their viruses will mutate and hit upon us homo sapiens.
    6. How many viruses will we stop? If a single Covid-19 can bring the world to heels, case financial disruption and cost billions of $$ in vaccine cost alone, leaving aside the other cost from secondary infections which poor people the world over will succumb to.
    7. The question is, can we as human beings as a race survive?
    8. Let us not do anything-pointless debates about climate changes & environmental damages. The question today is whether we as a human race will survive.
    9. Spanish flu is a recent history of around 200 years old. We have had SARS, MARS and now Covid-19. The trend is clearly visible.
    10. If we play and tinker with nature where it is not at equilibrium, nature will hit back at us. Face the consequences.

    I am sure, virologists and epidemiologists are there to dissect and solve this virus issue with a new vaccination . Few thousands will die here & here What does it matter? We will still go around damaging the environment we did as before.

    Long live homo sapiens !!!

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    Eur Ing (FEANI) Santanu Talukdar CEng (UK) CSci (UK) MIChemE SMAIChE
    Chartered Chemical Engineer
    Independent industry consultant-
    Innovations Mgmt & Technology Transfers
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  • 7.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 10 days ago
    Santana is right on with his concerns for the future.  The latest virus is just one problem.  

    However, they don't call us sapiens (wise) for nothing.  We'll get through it somehow, but with lots of collateral damage.  

    Good luck to all.









  • 8.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 9 days ago
    I am reproducing a very limited relevant information on vaccine development from my book: Design of Multiphase Reactors (2014, John Wiley & Sons Inc., USA) for general awareness. I believe that the Publisher should not have any objection at least for this stated purpose:
    ___________________________________________________________________________________________________________________________________________________________________
    Cell culture technology had a modest beginning (Table 7B.1). Its roots can be traced to the production of viral vaccines and other therapeutically important products secreted by human and primate cells such as those listed below (Karkare, 2004(a) ; Griffiths, 2007 (b)). Examples are: Foot & Mouth Disease, Rabies, Polio vaccine, etc
    Starting with this modest beginning of vaccine for the Foot and Mouth disease in 1962, cell culture technology has now progressed to a level where revolutionary treatment for malignant disorders, diabetes, etc. is available.
    Gonzalez-Valdez et al (2013)(c) have given an exhaustive discussion on the state of art in the field of vaccine development. They have pointed out that the recent occurrence of A/H1N1/2009 influenza virus pandemic calls for large scale, worldwide availability of relevant vaccines. These authors have also illustrated the advantages of DNA based vaccines over first generation (comprising attenuated (AV) or inactivated viruses (IV) and second generation (recombinant vaccines).
    a)
    Karkare SB. (2004) Cell culture technology. In: Kirk-Othmer, Encyclopedia of chemical technology, Published online Feb.13,2004, John Wiley & Sons Inc. New York, USA., vol.5, p 345-360
    b)
    Griffiths B (2007) The development of animal cell products: History and Overview. In : Stacey G, Davis J, editors. Medicines from Animal Cell Culture. John Wiley & Sons, Ltd, Chichester, UK. p 567-587. doi: 10.1002/9780470723791.c.
    c)
    Gonzalez-Valdez J, Aguilar-Yanez JM, Benavides J, Rito-Palomares M. (2013) DNA based vaccines offer improved vaccination supply for the developing world. J. Chem. Technol. Biotechnol. (wileyonlinelibrary.com) DOI 10.1002/jctb.4046
    Hope this is helpful.
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    Vishwas Pangarkar PhD
    Retired Professor of Chemical Engineering, University of Mumbai, India.
    Currently: Independent Chemical Engineering Academic/Professional.
    Nasik-422013, India.
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  • 9.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 7 days ago
    Hello Prof',
    Nice academic debates !!!
    There is however one simple point in your hypothesis which I want to contradict.
    Disposal of single use plastic waste and that too laden with bacteria. There is all the possibility of these plastic wastes contaminating ground water due to bacteria seepage or CO2 increase due to incineration.
    Advanced economies as EU/US have the respective technologies even to retrieve virgin PE/PP from plastics for recycling. There is a cost which the economy is ready to pay.
    For emerging economies as India and much of south americas, single use plastics is today a major environmental challenge. Clogging of marines, killing aquatic flora & fauna , clogging of earth pits, inability of natural bacteria to decompose & digest, etc.
    Single use plastics has multiple other challenges, where it is found to recycle in the food chain causing further health issues and damages.
    Govt. of India rightly took a step in the right direction to ban single use plastics..not necessarily with jute bags in retail chains, but also single use plastic technology, in my understanding which is equally to blame.
    You don't need multiple papers to substantiate the claim. Look all around, the economic damage is for all to see.
    I am not claiming that single use plastic reactor based technology cannot be used in biotechnology applications.
    Rather, I am contradicting the claim that it's the only available option, when there is an alternative viable option available today. The economic costs are too high to promote for single use plastic technology in emerging economy as in India or elsewhere. The cost benefits for economic recyling has to be brought into the picture, and who is to bear those costs.

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    Eur Ing (FEANI) Santanu Talukdar CEng (UK) CSci (UK) MIChemE SMAIChE
    Chartered Chemical Engineer
    Independent industry consultant-
    Innovations Mgmt & Technology Transfers
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  • 10.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 7 days ago
    1) SUT are unlike plastic bags. They are made from specialized materials and are not discarded in thousands of numbers every 5-10 min as happens all over the  world. I believe that the comparison is unwarranted. GE Healthcare/Sartorius are some of the suppliers who should be contacted on  disposal protocol. I am sure the numbers & handlers are not that large to be considered as threat to the ecosystem ( they are not part of garbage, municipal or other type)
    2) The multiple papers cited are  from highly reputed sources (Kirk-Othmer for instance) The paper by Gonzalez-Valdez et al is a very good read to know the distinction between current cell based vaccines and the earlier routes.Those who are interested should approach any reputed Univ who have access to Sci-Dir, etc. The websites of GE/Sartorius are free access
    3) I am considering the global scenario-not restricted to India.
    This effort was to distinguish between between SUT & other garbage. SUTs have several advantages over SS systems-the most important is "TIME TO MARKET". PL seeTable 3. Single-Use Systems Versus Fixed Stainless Steel Systems (https://onlinelibrary.wiley.com/doi/abs/10.1002/0471238961.koe00046.)
    4) There is no reference to SUT as the only option at any point. Those who wish to use SS are not prohibited to do so.
    5) In cell culture technology "Perfusion" is the term used for Continuous operation and it is certainly attracting lot of interest. This is a very mild statement & I certainly don't mean that it "is the ONLY one", etc.
    I think I should leave the matter at this stage for interested members to read the literature (academic papers/technical brochures, etc) cited in the previous posts.


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    Vishwas Pangarkar PhD
    Retired Professor of Chemical Engineering, University of Mumbai, India.
    Currently: Independent Chemical Engineering Academic/Professional.
    Nasik-422013, India.
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  • 11.  RE: Coronavirus vaccine candidates

    SENIOR MEMBER
    Posted 7 days ago
    For large scale manufacturing, there is a capacity constraint for using single use technologies, which is in current industry practice around 2000L. Above 2000L it's still SS based reactor technologies. Further with process intensifications based designs available it's possible today to move away from batch based designs and incorporate continuous  process into vaccine manufacturing. This design principle incorporates the QbD & the PAT centric design approach which is the fulcrum of any GMP based manufacturing which differs significantly from any organic based reactions.
    One has to incorporate the quality into the process design and validate it as per the approved regulatory requirements.
    Leaving aside the costs built into the design, I would still look at the economics of the scale from the downstream separators and the continuous processes to handle the quality variations in-situ.
    Higher capacity handling, and the economic cost of the design, including the life-cycle cost of economic recycle of single use plastic technologies vs. the SS technologies available today, I would like the users to look for options with SS technologies.

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    Eur Ing (FEANI) Santanu Talukdar CEng (UK) CSci (UK) MIChemE SMAIChE
    Chartered Chemical Engineer
    Independent industry consultant-
    Innovations Mgmt & Technology Transfers
    ------------------------------