Planning the commercial production and delivery of effective cell therapies will be key if the sector is to achieve forecast growth of $6bn within nine years, according to a seminar at the InterPhex trade event in New York City.
Robert Speziale of Invetech and moderator of the session Advances in Cell Therapies said: "....a lot of people are positioning to take advantage...," of a market forecast to reach $6bn, excluding imunotherapy and scaffold therapies by 2020. If imunotherapies were added the sector would be worth about $12bn by 2020, according to a forecast by Robin Young consultancy.
But most of the processes are lab-scale and not readily scalable, said Speziale. Current processes use technologies and procedures that are costly, labour intensive and need a high degree of skill, training and management to deliver a consistant and standardised product.
So, one of the challenges facing the sector is to progress from lab-scale technology to full commercialisation. For example, 20 clean-rooms with the same equipment and 100 staff might be needed to produce enough cells to treat 1000 patients. But producing enough cells to treat 10,000 patients could require 200 clean-rooms and 850 staff. Many small batch cell therapies have manufacturing processes that are not well-suited to currrent good manufacturing practice (CGMP).
Dominic Clarke, Charter Medical's product manager, stell cell freezing, highlighted the logistical challenges of processing and transporting fragile cells. "Unlike biopharma, the living cell is the product," he told the seminar. "The final fill is the finished product. There is no post fill filltration or sterilisation steps. So the product must remain contaninant-free and sterile from the initial source collection."
Another key challenge facing developers is delivering to patients a stable and effective therapy. Cell therapies are "a live product and there is only a certain amount of time than they can live," said Clarke. "How that product is delivered is oftentimes not thought about until the final point and by then it is too late.
"Time is viability and function. The longer it is sitting around, the less potent it will be," said Clarke.
Every step following the acquisition of tissue involves the loss viable cells so delivery systems need to focus on the end consumer - the patient, he added.
"Companies would save themselves a lot of time and trouble if they started with the end-user in mind."
Last summer, Dendreon's Provenge cell therapy received approval and hundreds of other cell therapy products are in development. Cell therapies are classed either as allogeneic or universal in application or autologous or patient specific.
Robert Deans, vice president regenerative medicine at Athersys told a trade publication recently: "Many new exciting cell therapies have come forward and are now entering either Phase 2 or Phase 3 pivotal commercialisation trials."