The firm's FlexFactory platform combines single use, disposable components and production-scale disposable stirred tank bioreactor systems, to provide the flexibility to produce several different products at a single facility. The contract services company also believes the technology allows manufacturing capacity to be established rapidly at vastly reduced cost compared to traditional systems.
"FlexFactory represents the next generation of manufacturing capacity," Mike Masterson, Xcellerex CEO, told In-Pharma-Technologist.com.
"Instead of fixed, stainless steel, hard-piped facilities for manufacturing biotherapeutics and vaccines, FlexFactory uses single-use, disposable technology to create portable, flexible manufacturing systems."
The company is accelerating commercialisation of the product in the face of the rapidly growing biotherapeutics market, which is currently worth around $50bn in global revenues. The Xcellerex disposable bioreactor (XDR), part of the FlexFactory platform, is already commercially available, and the entire FlexFactory system (including downstream purification) is due to be introduced in 2008.
Increasing demand for more flexible and cost-effective manufacturing capacity driven by this growing market as well as mounting industry focus on vaccines, means the firm could be well-placed to profit from its ability to provide this flexible manufacturing capacity.
"With its transformational FlexFactory platform, Xcellerex can meet the urgent need for rapid, flexible manufacturing technology to address emerging disease threats and bioterrorism, as well as expanded immunisation against seasonal influenza." said Dr Thomas Monath, partner at Kleiner Perkins Caulfield who are financing Xcellerex along with SCG Group and Byers. Monath has joined the Xcellerex board of directors as part of the financing agreement.
Current biotherapeutic manufacturing techniques tend to be based on traditional fermentation and purification techniques that involve large, stainless steel, fixed facilities. These require a substantial amount of investment in time and money, as well as an effective infrastructure to maintain the necessary conditions and facilities at the plant.
As a result, it is often difficult to make process changes once the facilities are fully established. However, Xcellerex's FlexFactory technology appears to offer a solution to this situation, and the company recently designed, constructed, installed and validated a FlexFactory system in less than six months at a total cost of over 50 per cent less than a comparable traditional facility.
The company has noticed increased interest in these disposable technologies within the pharmaceutical industry, and has already established a customer base of 'top tier' pharmaceutical and biotechnology companies.
The firm completed an initial $3.5m financing which was put towards constructing a GMP manufacturing infrastructure to produce clinical materials using the FlexFactory technology. The latest $20m round is set to be used to increase availability of the technology platform and expand sales and support organisations.
The company began GMP production of a monoclonal antibody for clinical trials for an undisclosed partner last year, and have further customers from the pharmaceutical and biotechnology industry lined up for 2007.