Outsourcing took longer to catch on in the biopharma sector than in the small molecule drug industry. Initially, biologic developers did production in-house with only activities like fill/finish being handed over to contractors.
In recent years this has changed. According to BioPlan Associates, in 2006 57.6% of biopharma companies did all their mammalian bioprocessing in-house, whereas last year only 44.2% did everything themselves1.
Partly this is because more CDMOs are adding the skills and technologies required to make biologic drugs as BioPlan CEO Eric Langer told bioLive.
“There is going to be a continuing need for uniquely skilled and competent CDMOs in niche, but high-value areas. There will be an expanding need for competent contract manufacturers as these novel therapies move through the pipeline.”
Langer cited cell therapies as a key opportunity for CDMOs because the technologies and methods used to make such products are still developing.
“Even though there are hundreds of pipeline cell therapy products, and many in clinical trials, the industry continues to evolve. Even basic elements such as whether the cell therapy platforms will be mostly based on autologous or allogeneic manufacturing technologies in five years are still being resolved technically and operationally.”
The growing complexity of modern biologic products is also increasing the amount of work being outsourced says Sylke Hassel, senior vice president of mammalian manufacturing at Lonza.
“Biologics are increasingly complicated” Hassel said, adding that biotech firms with an innovative molecule “may not have the expertise in all the different elements required to commercialise it.
“It can be a minefield for a young company and they are looking for partnerships where they gain more than just capacity,” she said.
Knowing which manufacturing method is best suited to a product is one area where a skilled CDMO can help according to Hassel.
“For example, microbial manufacturing may be a more cost effective solution for antibody mimetics and novel scaffolds. Or, in cell and gene therapy, developing a platform and processes that are scalable and reliable is paramount as we start to see more therapies moving from clinical to commercialisation.”
The point about demand for highly technical capabilities was echoed by Peter Coleman, CEO of Cobra Bio, who told us the trend prompted his firm to increase capacity.
“The main growth in our business over the last couple of years has been for both plasmid DNA and viral vector services. These have been mainly for gene therapy products with fast track status with the FDA for organisations based in the US. To such an extent we are expanding our facilities in both UK and Sweden.”
That said, demand for more straightforward bioprocessing services like fill/finish remains.
Coleman said, “Fill/Finish orders in 2017 also increased 26%, our most challenging field at the moment is our mammalian cell service offering which operates in a very competitive market.”
Economic factors are also increasing the amount of biomanufacturing work being outsourced.
According to Sylke Hassel from Lonza “Customers are increasingly looking for an integrated service provider that can cut time to market and decrease risk.
“Given the uncertainties in bringing an innovative medicine to market, small and large companies are looking to manage their investments and delay decisions. For a CDMO, offering flexible capacity is key, meaning that companies can quickly scale up if needed or hold while they wait for results or approvals.”
Hassel cited Lonza’s own partnering service – known as Ibex Solutions – which recently won French drug firm Sanofi as a customer2 as an example.
“It is a technology-agnostic biopark that taps into the existing manufacturing infrastructure in Visp, Switzerland. It reduces capital investment, simplifies the value chain and allows customers to secure supply according to needs.”