YM's revamped MAb facility gets thumbs up

By Anna Lewcock

- Last updated on GMT

Related tags Epidermal growth factor receptor

YM BioSciences today announced that the upgraded manufacturing
facility for the firm's humanized monoclonal antibody (MAb) for the
treatment of cancer has successfully passed a series of regulatory
reviews.

The company has upped capacity for the production of nimotuzumab, which is being developed by the company to treat cancers susceptible to radiation therapy.

The manufacturing facility used to produce the humanized MAb has been successfully scaled up to a capacity of 500 liters, using a continuous perfusion fermentation process.

The continuous process the company has chosen to employ uses a stirred tank perfusion bioreactor, which the firm says will deliver higher production capacity than batch production in bioreactors of the same size.

Although this capacity will be sufficient for initial commercialization of nimotuzumab, the company is planning to increase capabilities further during 2007, upping the site's manufacturing capacity to 1,000-liter scale continuous fermentation.

The Canadian firm also noted that Health Canada, the federal department responsible for reviewing such facilities, has issued a 'No Objection Letter', indicating that no deficiencies were found during its review.

This means that product manufactured at the 500-liter capacity can be used in clinical trials in Canada.

In addition to this approval, the manufacturing process and infrastructure has already been approved by another regulatory body in the EU.

Nimotuzumab itself is a humanized monoclonal that targets the epidermal growth factor receptor (EGFR), which has become a key target in the development of cancer treatments.

YM BioSciences has been developing the MAb to target cancers susceptible to radiation therapy, which is used in around half of all treatments for solid tumors.

According to YM, the overall market for EGFR inhibitors is estimated at over $5bn.

Nimotuzumab has already been granted Orphan Drug Status by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMEA), and according to the company offers significant advantages over other drugs in its class.

Other antibodies and small molecules which target the tyrosine kinase pathway can lead to unpleasant side-effects such as rash, hypomagnesemia (low magnesium levels in the blood), conjunctivitis, diarrhea and constipation.

Nimotuzumab, on the other hand, has rarely been associated such side-effects.

Nimotuzumab has already been approved in several countries for the treatment of various types of head and neck cancers, and is being developed by a number of licensees and the licensor for a range of tumor types.

As well as YM BioSciences, there are also other companies located over in Asia who will be involved in manufacturing nimotuzumab for other licensees, such as Biocon Biopharmaceuticals in India and Biotech Pharmaceuticals in China, where production is due to start shortly.

YM BioSciences were unable to comment prior to going to press.

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