In September, we called upon our readers to contribute to BioPharma-Reporter’s second annual ‘state of the industry’ survey, and over 350 industry experts shared their opinions. The finished report is available to download free here.
The survey covered a range of topics and concerns within the bioprocessing industry, including the types of cell lines currently used.
You may not be too surprised to read the majority of our respondents (71%) said they are working with mammalian cell lines, and a similar number (68%) believe mammalian cell culture will continue to dominate in ten years’ time.
But 45% of you told us you believe the industry is too reliant on Chinese Hamster Ovary (CHO) cell lines and a further 32% were not sure.
CHO money, CHO problems
Genentech’s plasminogen activator Activase became the first human therapeutic product produced using CHO cells in 1987.
Since then the cell line has become an expression system of choice for biomanufacturers and is used to make best-selling monoclonal antibodies Rituxan, Humira and Enbrel, to name a few. (For a full history of CHO cells in bioprocessing, check out this article.)
However, some biopharma firms and tech companies have criticised the expression system for being too expensive and inefficient. Fungal-based protein expression firm Dyadic International told this publication in August:
“Industry is starting to painfully experience the limitations of CHO expression yields for the next wave of biologics, bi-specific and tri-specific antibodies.The already low yields and high cost of producing biologics with CHO appear to make CHO unsustainable and commercially unaffordable for producing these more complex molecules.”
And some Big Biopharma firms, such as Biogen, have already begun looking at alternatives to CHO cell lines for future products.
There were a number of reasons as to why our respondents believe we are too reliant on CHO cells, but it seems the fact that the cell line is regulatory proven to be safe is key, with a third of respondents putting this as their main reason.
“Adaptation by regulatory agency for products developed in other cell line is very slow and challenging especially for biosimilar products on which big pharma giants are betting on to sustain their presence in biologicals,” one respondent told us.
The second highest reason cited was that CHO cell lines are used in a number of commercial products already, demonstrating further the low-risk factor of using such a tried and tested expression system.
“Successful track record (commercial products) is very important,” said another respondent.