Leaders in the fields of stem-cell regulation, manufacturing, and commercialization were interviewed to establish the following:
- What a large-scale manufacturing process would be for an allogeneic therapy with stem-cell expansion and an autologous therapy with stem-cell expansion
- The cost of each component of the manufacturing process
Selected individuals were sent an email requesting an interview. A total of 186 emails were sent, resulting in 32 individuals ultimately being interviewed (10 face-to-face, 19 by phone, and 3 via email). Interviews did not follow a rigid question format. The following four groups were interviewed:
- Experts in the regulation of stem-cell therapies in the UK and US
- Senior managers at leading stem-cell companies in the UK
- Prominent academics and clinicians focusing on stem-cell therapies
- Specialist companies focusing on specific cost components, such as the shipment of stem-cell products
A cost range for each component of the manufacturing process was established on the basis of minimum and maximum estimates obtained (see Table I). The cost range applies to both allogeneic and autologous therapy unless otherwise stated.
Table I: Cost range for each component of the manufacturing process for stem cell therapy. 1£ = US $1.6.
COST PER DOSE OF THERAPY
The following categories of data were calculated for allogeneic and autologous therapy:
Table II: Cost to set up a manufacturing facility capable of producing 2500 doses of stem-cell therapy a year. 1£ = US $1.6.
- The cost to set up a manufacturing facility capable of manufacturing 2500 doses of allogeneic and autologous therapy a year (see Table II).
Table III: Cost to manufacture 2,500 units of stem cell therapy a year, 1£ = US $1.6.
- The cost to manufacture 2500 doses of therapy a year (see Table III). This calculation did not take into account the cost of setting up the manufacturing facility itself. The figure obtained was divided by 2500 to obtain the manufacturing cost per dose of therapy.
Table IV: Cost to manufacture 2500 units of stem cell therapy a year factoring in the cost of setting up the manufacturing facility, 1£ = US $1.6.
- The cost to manufacture 2500 doses of therapy a year factoring in the cost of setting up the manufacturing facility (see Table IV). The calculation entailed dividing the cost to set up the manufacturing facility over its lifespan (i.e., 10 years). The manufacturing cost per dose of therapy was finally calculated.