The firm is spending over $100m to build a new seven suite small-scale injectable filling plant in Delaware, US, company CEO Les Edwards said in an interview at this year's Interphex trade show, held in Philadelphia. "For the past 20 years we have been helping pharma firms build sterile processing lines," said Edwards. "We have spotted a huge gap in the market for injectable contract manufacturing to fill small lots of material or clinical materials and we decided to fill this gap." Building new commercial sterile filling lines for clinical fills in-house is cost prohibitive - companies can easily spend upwards of $100m and take at least four years to develop sterile manufacturing capacity, but they are highly reluctant to do this until they are certain the candidate drug will receive regulatory approval, Edwards explained. Moreover, he said that existing large contract fillers are mainly interested in commercial scale manufacturing, which is more financially lucrative, and have no financial incentive to service clinical volume-size projects, while small specialist clinical fillers lack the necessary expertise and equipment to adequately deliver against a pharmaceutical company's complex needs. "Isogen was founded to specifically address the process, facility and capacity problems commonly associated with the highly-niched, low-volume clinical and early-stage commercial sterile filling market segment, and so this is what we are more interested in," said Edwards. "The feedback we have had from attendees at the Interphex show so far is that we are hitting a market niche for a real need that is out there, with the right facility at the right time." Within the new site, Isogen's science centre, which consists of an analytical chemistry lab, will be up and running in 2009. Edwards said this service, which will undertake testing to characterise compounds in the clinical stage, is particularly useful to small biopharma firms, who generally don't have any real specialty in the manufacturing side of things, in addition to the fact that biologic drugs are harder to scale up than small molecules. Meanwhile, the first four out of the seven small-scale manufacturing suites will be fully operational by early 2010. After this point, Edwards said that he anticipates the demand will already be there for the firm to go ahead and fit out the remaining three suites, which should take another 12 to 15 months. The expansion is being paid for by investors, bank loans and the pre-sale of manufacturing slots to "partner" clients with whom the company will work with on a long term basis for multiple drugs. About 50 per cent of existing capacity is expected to be pre sold in this way. Within the new facility, Isogen will accommodate liquid or lyophilised fills ranging in batch sizes from a few hundred to 30,000 vials or 100,000 syringes, on the same equipment, with common validation and document packages, "while setting new industry standards for sterility and containment assurance," said Edwards. Isogen will be using barrier isolation technology in each of its manufacturing suites "to provide best-in-class sterile processing for potent and non-potent compounds," he said. All equipment in the facilities will be built to handle potent products using isolation technology - every filling line is enclosed in an isolator, said Edwards. Because of this they will also be "advanced aseptic" filling lines, he explained. Part of the reason the company designed the facilities this way is due to the large numbers of biologic and potent anti-cancer products that are expected to start coming out of the pipelines in the near future. Edwards anticipates that half of all the products coming through the facility will be potent.
While the capital cost of installing isolators across the board is high, Edwards believes that it is balanced out by the high operational costs of running clean rooms, as would be required instead.