The Production and Development of Influenza Vaccines: Challenges and Questions - Essay Sample

Introduction

The development and production of Influenza vaccines are significantly different from those in the vaccine industry due to the frequent changing of its composition yearly. Notably, the production of Influenza has been on the cards for poor efficacy over the past two years, especially from the Northern Hemisphere, thereby creating more questions than answers on the manufacturing and purification process. Moreover, concerns have also been raised on how the composition of Influenza is being monitored and regulated (Feshchenko et al., 2012). Multiple notable opportunities and challenges have continued to be witnessed in vaccine development as important unmet and unattained needs, including Dengue, HIV/AIDS, malaria, and leishmaniasis remain. Therefore, the paper aims to focus and analyze how the seasonal flu vaccine or the H1N1 is manufactured while also exploring various technologies approaches used in the purification process.

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Manufacturing of Seasonal Flu Vaccine

Three different technologies exist in the manufacturing of the H1N1 vaccine, which has been approved by the United States Food and Drug Administration (FDA). The production technologies include egg-based flu vaccine, recombinant, and cell-based flu vaccine. Notably, a greater percentage of commercial seasonal flu in the US is produced by private sector manufacturers (Feshchenko et al., 2012). Varied manufacturers employ different production techniques. However, all flue vaccination is regulated and monitored and thus must meet FDA effectiveness and safety requirements.

Egg-Based Flu Vaccines

The egg-based approach is the mode common manufacturing process of H1N1. Most manufacturers have widely recognized the production technique for more than seven decades. The egg-based manufacturing approach is used to produce both 'flu shot' or commonly known as killed vaccine and live attenuated vaccines (Feshchenko et al., 2012). The production process starts the Center for Disease Control (CDC) or any laboratory is in partnership with the World Health Organization (WHO) global surveillance. The organization above and agencies provide private sector manufacturers with the candidate vaccine viruses (CVV) developed in the egg as per the recent FDA regulatory and compliance. Subsequently, the CVV is injected in the fertilized hen's egg and then subjected to incubation for multiple days to give the virus replication time.

After the replication of the virus, the fluid having the virus is then separated from the egg. The viruses are then killed, and the antigens subsequently purified. The manufacturing continues accompanied by quality testing, distribution, and testing. Notably, for the Live attenuated influenza vaccines (LAIV), the onset of CVV is active; however, it has weakened viruses passing through different production channels. FDA carries out a test and makes the approval on the vaccine before being released and shipped. It is worth noting that this production technique needs many chicken eggs to manufacture the H1N1(Feshchenko et al., 2012). Also, it may take a longer time than other production techniques substantially.

Cell-Based Flu Vaccines

The FDA approved the production technique in 2012. Until recently, the production technique commenced with the egg-developed CVV per FDA compliance and regulations. However, in 2016, the FDA issued a go-ahead to the Seqirus organization, which is the only approved cell-based flue producer in the US to start using cell developed and grown CVVs. The manufacturing process is used to produce an inactivated H1N1 vaccine, including the flu shot (Feshchenko et al., 2012). The processes involved in developing cell-based flu vaccines are numerous. First, the laboratory partner or the CDC uses the viruses in the grown cell to produce CVV, which are later available to the vaccine manufacturer. Second, the manufacturer injects the CVVs into the mature mammalian cell (which is opposed to egg) and then gives room for the CVV to multiply itself for some days (Feshchenko et al., 2012). After replication, the virus's fluid is extracted from the cell, and then the antigen containing the virus is purified. The production process continues as purifications and testing continue. The last process involves tests carried out by the FDA that approved the vaccine for release and shipment.

Recombinant Flu Vaccines

The production method was approved in the United States market in 2011, and it involves the use of an external technological icon. Notably, the method does not need a CVV sample to be manufactured but rather created synthetically (Feshchenko et al., 2012). In the recombinant manufacturing vaccine, the scientist or the manufacturer would first acquire DNA or the genetic instructions responsible for producing a surface protein called hemagglutinin (HA), located in the flu viruses. HA represents an antigen, a key feature of flue viruses that activate the human immune system to produce an antigen, specifically targeting the virus (Feshchenko et al., 2012). The DNA is used to manufacture the flu, and the HA antigen is combined with a baculovirus, which is a virus for the invertebrates, thus resulting in a recombinant. The recombinant virus then enters the FDA qualified cells or the host cell and then rapidly replicates it into the HA antigen, and then extracted, purified, and then packed. The DFA checks the quality before being released and shipped.

Method of Purifying Vaccine and Chromatographic Technology Employed

Ove the past years, significant breakthrough and transformation in bioprocess techniques have been evident, including multiple emerging innovative for vaccine purification. Notably, transformations such as advancement in downstream purification technology have come as a great boost to the vaccine industry in achieving consistent and quality results in product purification in a prompt manner, allowing for the efficient and effective vaccine production process (Feshchenko et al., 2012). Notably, many chromatographic technologies exist in vaccine purification, including downstream purification, affinity, high throughput, and continuous bioprocessing; however, the most common and ideal method in the manufacture of H1N1 is the affinity technological approach.

The affinity chromatographic technology is one of the most commonly used technology in the purification of seasonal flu since it is having been associated with the high achievement of fine separation quality even in circumstances of complex feed streams. Moreover, the deployment of affinity technology in H1N1 purification has been proven and tested by researchers. The method enhances purity and quality and a secondary objective of mitigating the number of operations in the downstream processes. Notably, its success in the laboratory scale proof aspect, the incorporation of affinity method in H1N1 manufacturing, has rarely been achieved due to its economic and technical complexities in such areas, including design and production ideal seasonal vaccine (Feshchenko et al., 2012). The affinity method has been associated with such advantages, including improve process architecture, improved productivity, flexibility, and reduced cost of goods. Moreover, with an adequate amount of ligand, sufficient purity can be obtained in just a single step, which permits the architectural process to be simplified to one affinity chromatographic process associated with prior clarification and a polishing step afterward.

Conclusion

In conclusion, the production, and the purification process of H1N1 is passes through multiple and complicated processes. The vaccines' production involves three primary methods, including Egg-Based Flu Vaccines, Cell-Based Flu Vaccines, and Recombinant Flu Vaccines. Notably, the ideal purification chromatography technology includes affinity methods with such advantages, including high purity and increased productivity, reduced cost, and improved architecture.

Reference

Feshchenko, E., Rhodes, D. G., Felberbaum, R., McPherson, C., Rininger, J. A., Post, P., & Cox, M. M. (2012). Pandemic influenza vaccine: characterization of A/California/07/2009 (H1N1) recombinant hemagglutinin protein and insights into H1N1 antigen stability. BMC Biotechnology, 12(1), 77.