A Pharma manufacturer, after consultation with top & middle management, decides to enter in the field of vaccine manufacturing. By using data from market research by third party, the composition of baskets of vaccines to be manufactured in the new venture are viral vaccine, bacterial vaccine & recombinant vaccine. Please provide information on the following points.
1. What kind of three vaccine class are you going to choose (one each) from each category based on minimization of cost & maximization of profit? 2. Write down a short schematic of upstream process flow for each category of vaccines starting from cell back preparation to purified antigens. 3. Write a short note on any licensed covid vaccine after literature survey with respect to Technology used for making it, development process & tentative number of subjects required for Phase 1, Phase II & Phase II Clinical trial.
4. Write a short note on comparison of three covid vaccines with respect to their techniques used for making recombinant clone.
Answers
Answer:
Vaccine Market By Technology (Conjugate Vaccines, Inactivated Vaccines, Live Attenuated Vaccines, Toxoid Vaccines, Recombinant Vaccines, and Other Vaccines), Indication (Pneumococcal Disease, Influenza, Human Papilloma Virus, Meningococcal Disease, Rotavirus, Varicella, Diphtheria, Pertussis, & Tetanus {DPT}, Polio, Hepatitis, Measles, Mumps, & Rubella {MMR}, and Other Indications), and End Use (Pediatric Vaccines, Adult Vaccines, and Traveler Vaccines): Global Opportunity Analysis and Industry Forecast, 2020–2027
Ans)1:-The availability of a safe and effective vaccine for COVID-19 is well-recognized as an additional tool to contribute to the control of the pandemic. At the same time, the challenges and efforts needed to rapidly develop, evaluate and produce this at scale are enormous. It is vital that we evaluate as many vaccines as possible as we cannot predict how many will turn out to be viable.
1)
To increase the chances of success (given the high level of attrition during vaccine development), we must test all candidate vaccines until they fail. WHO is working to ensure that all of them have the chance of being tested at the initial stage of development.
This is a major and extraordinary global research undertaking: WHO is facilitating collaboration and accelerated efforts on a scale not seen before; it is convening vital communications across the research community and beyond.
2:-
The production of viral vaccines in cell culture can be accomplished with primary, diploid, or continuous (transformed) cell lines. Each cell line, each virus type, and each vaccine preparation require the specific design of upstream and downstream processing. Media have to be selected as well as production vessels, cultivation conditions, and modes of operation. Many viruses only replicate to high titers in adherently growing cells, but similar to processes established for recombinant protein production, an increasing number of suspension cell lines is being evaluated for future use. Here, we describe key issues to be considered for the establishment of large-scale virus production in bioreactors. As an example upstream processing of cell culture-derived influenza virus production is described in more detail for adherently growing and for suspension cells. In particular, use of serum-containing, serum-free, and chemically defined media as well as choice of cultivation vessel are considered.