Developments in the technology of utilizing liquid nitrogen instead of
the industry standard of dry ice are revolutionizing the shipping of
biochemical samples, vaccines, and hazardous materials. The company Cryoport,
Inc. (OTC.PK: CYRX) is developing a suite of one way, cryogenic
shipping containers, which utilize liquid nitrogen, and allows for the
possibility of bypassing several of the drawbacks that make dry ice shipping
a relatively unreliable and costly process. Cryoport estimates that the
total available market for cryogenic one way shippers is in excess of $3
billion, using only the pharmaceutical and biotech industries as a
benchmark. The company recently announced that one biotech firm placed an
order for Cryoport's current reusable shipper and will need several hundred
additional units over the next 6 months. Brian Eriksen Noer reports.
The transportation of infectious, biological, and
chemical materials, as well as vaccines, has traditionally relied upon the
use of dry ice packed into specially designed and insulated shipping
containers. This method of shipping, while prevalent is not without its
drawbacks, including time and temperature constraints, in addition to rather
complex handling procedures for the shipping agents. Developments in the
area of liquid nitrogen based cryogenic shipping containers have brought the
previously cost constrictive technology to within acceptable parameters of
affordability and efficiency, so much so in fact, that cryogenic shipping
has now become a viable alternative to traditional dry ice (which is itself
categorized as a hazardous material) shipping methods.
The use of dry ice shipping containers is constrained
on airplanes due to weight and toxicity. Therefore, baggage handlers need to
exercise special care when handling dry ice and this type of container may
also be bumped from flights in which animals are stowed in baggage
compartments. Dry ice also typically sublimes back to a gas within 48 hours
in most packages. This unreliability can have costly consequences when the
required temperature parameters are pushed to the extremes during the trip
from origin to destination.
The development and use of liquid nitrogen in specially
designed cryogenic shipping containers is reaching an increasingly
affordable price range, and also negates many of the drawbacks associated
with traditional biochemical shipping procedures. In addition, liquid
nitrogen, in the vapor phase, is not considered such a hazardous material;
consequently, its use is far less restricted than the use of dry ice as a
refrigerant. One company working towards the mainstream adoption of this
technology is Cryoport Inc. (OTC.PK: CYRX).
Cryoport's cryogenic shippers have been certified for
the safe transport of infectious materials such as anthrax as well as other
diagnostic and infectious biological material and, are therefore able to
assist in helping provide countermeasures against bioterrorism. These same
shippers have also been recently evaluated by departments within the US
military as capable of providing a more effective transportation system,
over any other methods currently available today, for such biologicals.
Cryoport Inc.
Cryoport was founded in 1999, and until 2002 was
working on the development and design of re-usable cryogenic shippers. In
mid 2002 Cryoport re-engineered their product to be more substantial and in
the process improved upon the reusable aspect of their containers. "Our goal
was to bring to market a one way shipper, which could be used to transport
specimens without the worry of getting the container back, making it
appropriate for Homeland Defense applications, especially given the current
situation in which most countries are very much on the defensive" said Peter
Berry, Cryoport CEO.
"A one way shipper negates the costs of container
ownership: asset tracking and maintenance, shrinkage of inventory, return
shipping costs and decontamination. Our focus is on a one way throw away
unit, which after it has been used to transport infectious materials, can be
disposed of very easily."
CryoPort's plan is to bring to market a range of one
way shippers; including the capacity to ship single or multiple doses, and
multiple holding times: 8-10 day units for "in country" use or 12 - 16 day
units for overseas shipment. The company had planned to announce the roll
out of a series of one-way shippers of varying capacities, between the
middle of this year to early 2006, however due to an accelerated R&D
schedule (as the result of additional funding) the development stage of the
"phase one" shipper is now complete. Prototype models of the new disposable
cryogenic shipper are scheduled to be made available to select clients as
early as this month.
"We are working with
several companies in the biotech industry," continued Berry, "who are
currently in clinical trials with vaccines. These vaccines are living cells
and therefore require the use of cryogenic temperatures not only during
storage but also during shipping, as opposed to using dry ice. Cryogenic
preservation at the time of manufacture can only happen at a temperature
below minus 150 centigrade. These vaccines could be shipped via
conventional dry ice containers; however the survivability window is only a
few days, which is not enough time to ship the vaccine safely overseas. One
biotech company that we are working with is therefore looking to embrace a
cryogenic shipping solution. The number of single dose shipments that they
anticipate shipping over the next five years averages 250,000 doses per
year. Another biotech company recently purchased 100 of CryoPort's reusable
lightweight shippers with a projected need over the coming months for
several hundred more."
Dry Ice versus Cryogenic Shipping
According to Berry, there are two drivers for the mass
industry acceptance of a cryogenic shipping protocol: one is for material
that requires cryogenic preservation in order to maintain the effectiveness
or survivability of a specimen. "This type of specimen has to be stored at
cryogenic temperatures and carefully cooled using cryo-protective agents.
This is called cryopreservation and only liquid nitrogen can do that, dry
ice cannot and as the biotech industry becomes increasingly more involved
with complex molecular and cellular materials there will be a greater demand
for cryogenic shipping."
The use of cryogenic shipping is also being driven by
the need for reliability of temperature, cost effectiveness and convenience
of use. "A large majority of specimens today are transported by dry ice and
may not require cryopreservation," said Berry, "but if we are able to offer
an easier to use, more cost effective and reliable protocol for moving
specimens, there is a greater chance of adoption by the industry."
Historically there has not been a reliable, easy to use
cryogenic solution. The containers currently in use are expensive,
constructed of metal, and usually built to accommodate multiple specimens of
50 or more. This type of cryogenic container has not been a practical
option. By manufacturing a "cryogenic overnight box type of concept" (as
Berry puts it) cryogenic shipping competes very nicely with the dry ice
solution currently available, and removes the impracticality of having to
physically handle large amounts of dry ice in the process.
Drawbacks exist with dry ice shipping: large quantities
of dry ice are required by weight, usually 20 to 30 pounds, within the
packaging to provide a 48 hour holding time for the specimens. In addition,
these specimens are typically only shipped mid week, therefore if shipments
are made towards the end of the week the weekend storage time requires
re-icing of the container.
Another drawback to dry ice shipping occurs when
specimens increase in temperature and then deteriorate. In this scenario the
impaired results obtained during specimen analysis not only affect accuracy
but also make drug effectiveness and dosing studies very difficult to
complete and hence delay time to market. Clinical trials often anticipate
and build in the hidden cost of loss of specimens along the transportation
line.
Cryogenic containers are currently manufactured out of
metals. The use of metal components affects the ability to manufacture such
containers in high volume. In phase two of their operations, Cryoport plans
to utilize component materials such as plastics and polymers. "Unlike
metal," said Berry, "which involves welding, container components made out
of molded materials can be glued together. This mass manufacturing technique
will allow us to build tens of thousands of containers per month. A typical
cryogenic vessel manufacturer would build fifty thousand containers per
year.
By comparison the company referenced above, projecting
an annual need to ship 250,000 doses would be making an average of 40,000
single dose shipments per month.
Berry explained that plastics and polymers do have
permeability issues, however since their shippers are designed for one-way
transportation only, the process can tolerate some amount of permeability by
using chemicals to mop up some molecular seepage and also due to the
shipping container's shorter shelf life. This is the type of R&D that
Cryoport is currently working on.
Brian Noer
Brian Noer has a degree in Business and Economics from the University of
Western, Ontario. His career in the financial markets spans fifteen years
and several continents, including: Manager with The Bank of Montreal in
Canada, Associate Analyst with the structured finance group at Moody’s
Investor Services in the UK, and Editor for several financial trade
magazines in the UK for both Thomson Financial Publishing and Euromoney PLC
(titles include Thomson’s trade magazines “The International Securitisation
Report”, and “Capital Market Strategies”, and Euromoney’s “Asset Finance
International”). Brian recently joined the InvestorIdeas.com portal team as
a Writer, Editor and Research Associate.
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