With an aim to develop affordable, top quality culture media for reducing cost of monoclonal antibodies (mAbs) in India, the Mumbai-based HiMedia Laboratories, a leading biosciences company, is set to commence manufacturing of chemically defined serum free media (CDSFM) by the end of 2018. The media is used in culturing Chinese hamster ovary (CHO) cells for mAb production. The upcoming production of CDSFM at newly developed facility of HiMedia in Nashik will be Pharmaceutical Inspection Cooperation Scheme (PICS), European Medical Agency (EMA) and cGMP compliant. The company has earmarked around Rs.20 crore for this. The mAbs are used not only in cancer therapy, but also in many chronic diseases such as arthritis, psoriasis, etc that are very commonly prevalent in the general population. So, their consumption can only increase over time as their affordability goes up.
In Nashik, the company already has a manufacturing unit. The newly developed plant spanning over 30,000 sq feet is located next to it. The plant will be able to manufacture CDSFM in bulk and we have already installed some very sophisticated world class production machines for these media, said Dr Vishal Warke, director, R&D, HiMedia Labs. Culture media account for around 30-35 per cent of the cost of the antibody in terms of the operating costs, especially those monoclonal antibodies which are produced through perfusion technology. If these costs are brought down, the mAbs can definitely be made more affordable, said Dr Warke.
The HiMedia mission has always been to serve our nation with world class products that are import substitutes, but at the same time very affordable. Continuing in this same spirit, we realized that presently these mAb ‘Magic Bullets’ are unaffordable in our country. This gave me a special impetus to design and plan this CHO CDSFM media project, said Dr Warke. In the future we foresee perfusion based technologies coming in along with single use disposables reactors. Due to this the cost of operations and reagents will reduce significantly and the ability of the biopharma to produce large quantities of mAbs from a smaller and a more nimble production facility will be enhanced. The only hitch in perfusion technology is that though all the general and specific costs will reduce, the media usage will shoot up drastically as the media here flows in and simultaneously out into the drain in this technology.
Thus the need for good quality and affordable CHO CDSFM is even more acute. We intend to fill this gap to enable companies to enhance production volumes and yet keep their costs low, he said. Talking about HiMedia’s contribution to growth of biopharma industry in India, Dr Warke said, “We can today custom manufacture a CDSFM for mAbs by taking in the clone (under CDA license from any Biopharma) in our R&D and bioprocess optimisation facility, and through Design of Experiment (DOE) studies, develop the most optimized media that will give good growth as well as mAb titer coupled with the correct Glycan profile. Moreover we can optmize the bioprocess parameters and guide the biopharma through their scale up. This is a very intricate set up and needs a huge investment, which we are now almost completing. This facility that we will shortly offer in India will be a significant contribution from Himedia to the biopharma industry.”
Talking about HiMedia’s latest initiatives related to biotech segment, he said, “We are also developing many serum free media for the vaccine industry (animal as well human vaccines). Another exciting area that we are working upon is the media for stem cells and primary cells. The next wave of the future which is now visible on the horizon is ‘Regenerative Medicine’. To support regenerative medicine, organ regeneration etc, we are developing media and systems for large scale differentiation and culture of various cell types.” The company accounting for a 90 per cent market share of culture media in India has six WHO-GMP certified manufacturing facilities in Maharashtra spread across Nashik, Ambernath and Dombivali. It is exporting to more than 150 countries, including Japan, the US, European countries, Russia, other Asian Countries, Brazil and Argentina.
Source : www.pharmabiz.com
Published on: May 30, 2018