During the past two years, the two companies have manufactured recombinant proteins and monoclonal antibodies using PER.C6 technology, which uses cell culture for the large-scale production of recombinant proteins and monoclonal antibodies.
One year ago, the companies set a target for their monoclonal antibody fermentation yields to reach 10 grammes per litre. This milestone has now been reached, with significant impact on the cost of manufacturing antibodies. But DSM Pharma says it will continue to accelerate production to reach 20 grammes per litre by the end of 2007.
"At the moment, the cost of goods is at $1000 per gram on average in the industry, where yields are at two grammes per litre," Terry Novak, chief marketing officer at DSM Pharma, told In-PharmaTechnologist.com.
"If you take it from two to ten grams per litre you can see what it does to the cost of an antibody, if you are a biotech company."
The companies are currently undertaking confirmation runs but expect commercial availability during next year. Moreover, they intend to apply the technology to clinical trial material production by the end of 2007.
One of the firms' next challenges is to work out the size of the production vessels and reactors needed. At present, the low production yields have required large bioreactors (10,000 - 20,000 litres) but DSM Pharma speculates that no more than 1,000 litre reactors will be required, depending on facilities present, for increased production yields.
It will take an average of 15 days to produce yields of 10 grammes per litre, according to DSM Pharma. The strengths of the PER.C6 technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
To date, Crucell and DSM have signed 20 PER.C6 licenses for production of various proteins, including licenses to companies with marketed proteins such as Merck, Roche, Eli Lilly/AME and J&J/Centocor.
DSM Pharma expects significantly more companies to purchase licences, due to its increased fermentation yields.