Lonza has scored a contract manufacturing agreement from Osiris Therapeutics for its investigational adult stem cell therapy is building a new facility to support future business activities in this area.
The Swiss manufacturer will be responsible for the clinical and co mmercial supply of Osiris' lead candidate Prochymal, which is being evaluated in Phase III clinical trials for three indications - acute and steroid refractory graft versus host disease (GvHD) as well as Crohn's disease.
The drug is also being developed for the repair of heart tissue following a heart attack; the protection of pancreatic islet cells in patients with Type I diabetes; and the repair of lung tissue in patients with chronic obstructive pulmonary disease (COPD).
Through Prochymal, Osiris is hoping to launch the world's first stem cell drug and chief operating officer Harry Carmitchel said that its new relationship with Lonza is a "significant milestone" in the company's efforts to commercialise the product.
No specific terms of the agreement between the pair were disclosed, although Lonza did reveal that in preparation for the commercialisation of the drug it is constructing new production facilities.
This includes the establishment of the first commercial-scale allogeneic good manufacturing practice (GMP) manufacturing facility, along with the creation of additional capacity to manufacture GMP grade cell culture media for therapeutic applications.
The site will also be used by the firm to generate new business in commercial-scale adult cellular therapeutics manufacturing in the future - an emerging production area.
According to market researchers BioPortfolio, one of the biopharmaceutical areas fuelling industry growth is stem cell therapy. Many investors and large companies that have preferred to avoid the possible controversies of embryonic stem cells are finding alternatives in adult stem cells.
The potential use of adult stem cells for therapies may offer substantial opportunities for cell therapy companies looking to capitalise on a market that is currently estimated to exceed $500m in the US and Europe.
David Smith, head of Lonza Bioscience Cell Therapy said: "This multi-million US dollar, state-of-the-art therapeutic cell production facility will provide Lonza with the capacity to manufacture the tens of billions of cells per day needed to support its clients' commercialisation efforts".
Lonza is "committed to support the commercialisation efforts of our cell therapy clients", he said, adding that the company's "considerable investments" in research and development (R&D) and supply chain logistics will also deliver "substantial value" to its clients in terms of "clinical and commercial execution."