Views from a vaccine manufacturer: Q&A – Abdul Muktadir, Incepta Pharmaceuticals

The debate around technology transfer is proving to be critical in addressing shortages in the production of vaccines. We wanted to know from developing country manufacturers on the challenges they face in making vaccines for COVID-19. Geneva Health Files brings you an interview with Abdul Muktadir, Chairman and Managing Director of the Dhaka-based company Incepta Pharmaceuticals Limited.

Established in 1999, Incepta specialises in biosimilars and vaccines, employing nearly 10,000 people and producing about 1000 different medicines and vaccines – including oral cholera vaccines, vaccines for influenza, measles, rubella, and Hepatitis B. Incepta exports to 67 countries across the world, has 3 manufacturing sites, and 17 factories and research facilities.

Geneva Health Files (GHF): What, according to you, are the real impediments for technology transfer in the process of production of vaccines in the developing world? 

Abdul Muktadir (AM): The innovator companies are preoccupied with the supply commitments to the governments from which they have taken advance payment. They have successfully transferred the technology to all the Contract Research Organizations (CROs) so the technical difficulties that are often referred to may not be a big impediment. The innovator companies are at ease working within their comfort zone and do not want to deal with unknown companies.

This is the real barrier that the innovator companies do not feel comfortable working with many companies from the developing world.

Abdul Muktadir, an industrial pharmacist by training, who is Chairman & Managing Director for Incepta Pharmaceuticals Limited

GHF: In policy debates in Geneva, developed countries argue that intellectual property has not been a barrier for the production of vaccines. What are your thoughts on this? 

AM:  In the current context, the IP right is not the impediment as the companies from the developing world would act either as a CRO or as a license holder. The innovator companies should utilize as many manufacturing bases as possible and then increase their production. In this case there is no issue of IP violation.  

GHF: It has also been argued that developing country manufacturers may not have the skills and equipment to engage in technology transfer. What are your views on the expertise and manufacturing capacities in the developing world?

AM: There are several technological platforms for production of currently approved COVID-19 vaccines, and for each platform there are differences in upstream and downstream processes. The vaccine manufacturing is not very widely distributed but the companies that manufacture vaccines – they understand the process fairly well.

So, the capacity and expertise are available with the manufacturers of the developing world – otherwise Serum Institute and other Indian manufacturers would have faced difficulties. The equipment might require some re-tooling to accommodate the new process but certainly it is possible. 

GHF: As a developing country manufacturer, what in your view is a preferred way for technology transfer: non-exclusive licensing or bilateral arrangements? And why?

AM: Here, the primary objective is to increase the volume of production. My argument is: if a company can deliver 1 billion doses a year then we should try to increase that capacity to 4 billion using the same principle. No company was prepared to deliver 1 billion doses a year, but the companies are doing this now. The task of manufacturing should be distributed based on the capability of each manufacturing partner.

The best way should be to mass manufacture antigen [vaccine active ingredient] bulk in a few places and then the antigen could be distributed for fill/finish wherever the capacity is available. 

We are referring to any licensed Covid-19 vaccine such as Moderna, Pfizer, Astrazeneca, Johnson & Johnson. If we receive the active bulk ingredient, we have the capacity to fill and finish.

This way we can involve many companies in many different countries. This would also eliminate impediments on cross border transportation. We observe now that most of the manufacturing countries are putting barriers in previously agreed supply commitments. 

The above process would involve both non-exclusive licensing and bi-lateral arrangements. We can avoid non-exclusive licencing if the innovator company can make the agreements through multi-party contract manufacturing. In such a case the technology transfer requirement would be as per the requirement of each task. If the bulk antigen can be produced in a few places then the requirement of tech transfer would be very minimal, and the innovator company’s technology can remain very well guarded.

The current technology of manufacturing the COVID-19 vaccine is probably known to many vaccine companies, including companies from the developing world like ours. The biggest challenge in introducing a new vaccine is to successfully conduct an efficacious clinical trial and this remains the main barrier for a new vaccine. So, our best option would be to manufacture the already-approved vaccines on a massive scale and provide them fair reward for their innovation.

GHF: Can you share specific details on your operations in Bangladesh in terms of capacity for technology transfer? What would be the easiest vaccines to produce and what are the potential areas for improvements in your manufacturing plants?

Incepta Pharmaceuticals has full-scale vaccine manufacturing facilities – including antigen production lines, bioreactors, and fill-and-finish capacity.

AM: We have full-scale vaccine and biosimilar manufacturing facilities. We can manufacture bulk antigen using almost all technology platforms. 

We have the bulk antigen production facilities which could be utilized to adapt almost all technology platforms (e.g. mRNA, DNA, adenoviral & insect/baculoviral etc ) available for COVID-19 vaccine. 

For example, we have developed a meningococcal polysaccharide subunit vaccine (ACYW135), hepatitis B sub-unit vaccine (VLP based), and whole cell oral cholera vaccine from our own bulk, and obtained licensure for these vaccines in Bangladesh. Moreover, a cell culture-derived rabies vaccine that we developed is in a clinical trial now. A pre-clinical study for typhoid conjugate vaccine is on-going. In addition, we have more vaccines in the pipelines.

Depending on a particular process we have to re-tool the facility to accommodate the manufacturing of a new vaccine. Once we have a process in hand, then we would know the extent of re-tooling requirements. Once the facility is ready then we have to optimize the manufacturing process and it requires some time.

For us the easiest COVID vaccine technologies  would be the protein subunit vaccines [such as the one produced by Novavax] and mRNA vaccines [such as those produced by Pfizer/BioNTech and Moderna]. We would also be able to manufacture adenovirus vaccines.

We have the bulk antigen production facilities which could be used to adapt technology related to mRNA vaccines and protein subunit vaccines for COVID-19. 

We have a 500L bioreactor which could be used to produce insect cells/baculovirus based protein sub-unit vaccines like the one from Novavax. 

At the moment, we have a licensed protein sub-unit vaccine for hepatitis B which we developed using the yeast technology platform. 

If we have access to mRNA technology, we believe we can easily adapt this technology. We have all the reactors and purification tools required for mRNA vaccine production.

If we get the antigen then the production can start immediately, as we have two and a half production lines sitting idle. In one line we can handle multiple dose vials, and with 20 doses a vial, we can deliver about 500 million doses a year. If we re-tool the other two lines for larger, multiple vial capability then we would be able to deliver another 600 million doses. But this would require a lead time for the supply of tools from machine manufacturers, and this may require a lead time of 6-8 months. But we now have one line fully ready to deliver about 500 million doses a year in multiple dose vials (the lines we have are suitable to fill any type of vaccine).

At the moment we don’t have any deals with any innovators.

Priti Patnaik is the founding editor of Geneva Health Files – a reporting initiative that tracks power and politics in global health. This interview is a part of a series under a collaboration arrangement between Geneva Health Files and Health Policy Watch.

Image Credits: Incepta.

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