Viacell chose SEPAX

Well, it wouldn't be fair that other automated systems aren't discussed on this blog.

A burning question you must all have is:

What systems are all the other cord blood stem cell companies using?

Well, last year, Viacell announced in a short brief that they were integrating automation into its existing closed processing system using the SEPAX system, designed and manufactured by BioSafe, a Swiss rival of Thermogenesis.

The announcement stated that:

"SEPAX is the only FDA cleared cord blood processing system. Biosafe received FDA clearance in January 2007 and European CE mark approval in 2001."


THE SEPAX MACHINE: WHAT IS IT?

The SEPAX automated processing system is an all-in-one machine which is achieves a similar outcome of stem cell separation through an in-built centrifugal technology. It is approximately 14 Kg in weight (2 year old baby) and reminds me somewhat of a large square automated rice cooker (the newer Sanyo versions, that is).

The separation of stem cells from other blood components is achieved in a central core which spins the blood at high speed and through an optical reader, squeezes the separated components into the various compartments until the process is complete (watch the Quicktime animated demo). SEPAX kits are single use (just like AXP) and come with an option of storage bags, although it is rumoured that the kits will soon only come with a single compartment bag as Thermogenesis is revoking permission for the dual compartment design use (business as usual for public banks but potential consumer's angst in private banks).


THE PROS AND THE CONS

Let's start with the Pros.

1) The machine does away entirely with a centrifuge (no Beckmann or Sorvall)
2) One unit processed at a time
3) Portable
4) Closed system
5) Single disposable kit
6) No requirement for clean room
7) Used and endorsed by major european cord blood banks affiliated with Netcord*

The Cons.

1) Each unit takes approx 40 mins to process
2) One machine processes one unit at one time
(i.e. if you have 1 machines and 10 units, it will take you approx 5+ hours to complete the lot, more machines = more costs)
3) Possible breakdown of light detector (replacement downtime?)
4) Limitation of single compartmented storage systems
5) Technical oversight to ensure that the initial connections are placed correctly
6) Price (the euro has been incredibly expensive since last year)
7) Service when things go wrong (specialized engineer required from Switzerland)

CONSIDERATIONS FROM THE USER'S PERSPECTIVE

Both the AXP and the SEPAX have their pros and cons, and as a potential user, I'm interested in knowing the breakdown rates and other problems banks have in using the system. These are usually not disclosed and the user takes on the risk to find out. Unlike public banks which can afford to discard units which don't turn out right, private stem cell facilities have zero tolerance for error as every single one hurts both the client and the company's balance sheet. Additionally, if the system does not work out for the company for whatever reason, the expensive asset has to be written off (may cost millions) which would be an extremely painful decision to make.However, unlike the AXP system, the SEPAX system has been in use for a while and has not released any public recalls of their product. Hence, the only reason that I can think of for its slow uptake in the rest of the world is that unlike Europe, which promotes public banking largely for blood cancer use, America and the rest of the world is promoting cord blood stem cells for regenerative use- hence the need for a multi-compartmented bag- which is a different concept entirely.


PROFIT & LOSS

Certainly all companies selling the automated systems would stand to profit greatly from entering the cord blood stem cell market. Cord blood stem cell banks can still use generic products on the market, making it relatively affordable to bank as long as the team is technically competent. Now, automated systems will increase general standards of quality for those with less well trained staff (its a matter of practice and the total experience) but it also pushes prices up for the consumer or makes it less profitable for smaller operators. Public banks will also need to campaign for more funds in order to buy new systems and costs of processing will need to be revised from previous proposals.

For now, the small number of options in automated systems commands a forced loyalty as each system only accepts their own product. Many of the stem cell banking services that face the consumer directly will await the day that there is a generic design of standard quality which can be used with any machine, which will be more open to price transparency. Of course, that day may still be far away until either governments have budget surpluses to devote to a huge volume of public banking (when it takes precedence in funding over other healthcare priorities) or legislate to provide a conducive environment for the public to exercise their choice to bank privately should they wish to.

KNOW WHAT YOU'RE PAYING FOR

There is no doubt in my mind that automation is inevitable at some point but let's not forget that this is still version 1 with potential to move to version 2. In the meantime, I'd like to see who and how the AXP system and SEPAX system is used in private hands, and whether it is used according to manufacturer's recommendation** to achieve the desired result.


*Prof. Eliane Gluckman's - the first cord blood stem cell transplanter- facility Eurocord uses the SEPAX system, in direct rivalry with AXP whose public endorser is the New York Cord Blood Bank led by Dr. Pablo Rubenstein who developed cord blood storage procedures in the US.

**Manufacturers recommend certain minimum volumes and maximum volumes to be used with their system. Any deviation of this will not result in the promised outcomes, hence clients who are paying more for the promise of this system but don't meet the criteria will still ultimately be getting manual processing (which works well in a competent facility but not in one where the practice is limited).

The point of these systems is also to provide a "functionally closed" system of processing and there certainly wouldn't be any point in using the automated system if you had to transfer the cells from the final bag into a different storage method (e.g. vials) at the end, which would break it into a "functionally open" one instead.