Cardinal Health says it is experiencing a "robust market" for its cell line engineering technology, as it attracts the attention of pharma giant Wyeth and executes capacity expansion plans its for full service offerings in the field.
The US-based firm has recently signed a new feasibility study deal Wyeth as well as Trubion Pharmaceuticals, to use its patented GPEx technology to develop mammalian cell lines for the two firms at its plant in Wisconsin. Financial terms were not disclosed.
Cardinal said it will use GPEx to engineer cell lines that express two of Wyeth's undisclosed biopharmaceutical molecules, to determine if this process can improve upon the one already being used by Wyeth in-house.
"If at the end of the study Wyeth is pleased with the result, they may decide to continue using GPEx to manufacture the molecules, either in-house or by outsourcing to us," Paul Weiss, president of Cardinal's biopharmaceutical development services center, told Outsourcing-Pharma.com.
"Furthermore, if the GPEx approach is found by Wyeth to be a feasible augmentation to its current production methods, it is also possible that Wyeth will consider using our technology to feed into their internal system that is used to develop all their other biopharmaceutical molecules too."
This would mean that Cardinal could use our GPEx technology to insert the desired gene into the mammalian cells for Wyeth and they would take over from there and develop the process internally using their own expression technology, Weiss explained.
"We do not actually licence GPEx to any firm, although, we would consider doing so if we were presented with the right size deal from a large pharmaceutical firm, such as Wyeth."
Similarly, the deal with Trubion serves to investigate a new method to rapidly produce biopharmaceuticals that are one-third to one-half the size of traditional protein-based medicines, called small modular immunopharmaceticals (SMIPs).
Because of their smaller size, the firm hopes that SMIP proteins will facilitate tissue better penetration in certain disease states, such as cancer and arthritis, while retaining the beneficial therapeutic characteristics of larger molecules.
The company is currently searching for an efficient and cost-effective way to produce enough of a drug candidate containing one if its SMIP molecules to enter early phase clinical trials.
If Cardinal's GPEx is all it is claimed to be, it may provide exactly what both Wyeth and Trubion are looking for.
With approximately 500 biopharmaceuticals currently in clinical development, Cardinal said it was facing a "robust market" in terms of interest in its GPEx technology and already has 30 various deals in place with biopharma firms.
Existing technology can take 12-18 months to develop transgenic cell lines - a crucial step required before sufficient quantities of the protein or antibody needed can be produced that form the basis of a new generation of biopharmaceuticals.
"However, GPEx can generate stable cell lines that exhibit significantly higher levels of expression than those cell lines generated by standard methods and can achieve this in as little as four to six months," said Weiss.
"The technology is suitable for the rapid cell line development and production of gene products, as well as antibodies and other therapeutic recombinant proteins."
The time it takes Cardinal to produce clinical trial quantities of a drug varies according to each clients' needs, but typically the GPEx technology "can quickly produce the industry standard - 1g/L - of engineered cells that can be used to make 200g of drug product which is usually sufficient for early phase trials," Weiss explained.
"While our clients are running the early trials we can then go on to develop the process further until we can produce 2-3g/L engineered cells and then make 200-400g of drug product, which is usually enough for Phase II trials."
Currently Cardinal is operating its bioprocessing tanks at a 200L scale and doesn't have the capacity to go beyond phase II production, however, the firm is in the process of an ongoing expansion plan, which includes installing larger tanks and hopes to have this completed within 12-18 months.
"This will enable us to expand our service offerings right through to phase III trials and commercialisation," said Weiss.
In the meantime, Weiss said that the company maintains a flexible business model and "hasn't settled on a firm business strategy" for the service offerings surrounding the technology and is also exploring several partnership options with other contract manufacturers, including those based in offshore locations.
"Many customers may be looking for a low-cost option when it comes to biopharmaceutical production, for example," said Weiss.
"We also offer the advantage of being the only company that can offer biomanufacturing services covering everything from front end development and manufacturing right through to analytical testing, fill and finish as well as clinical and commercial packaging."