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General Costs and Time
If the target analyte and
necessary antibodies are available, assay
development generally costs between $30,000 -
$100,000 and usually takes 4-8 months. Once
developed, continued production of the kit
typically costs $50 - $300 per 96-well microtiter
plate kit (see Typical
Kit Components). Finished rapid tests may
range between $0.50 - $5.00 per strip or cassette.
The cost of manufacturing depends on the
composition of the reagents and how many kits you
will need in a year. Several sample proposals
are listed here.
Sample
Proposals
Proposals
are often broken down into 4 phases, which detail
time and cost estimates (see the sample proposals
listed here). Payments are typically
structured with a front fee of 30% of the estimated total, and milestone payments disbursed
thereafter, which can be paid after each phase or
monthly. For
examples of pricing and time-lines for assay
development, see the following sample proposals:
Microtiter
Plate Antibody-Sandwich Sample Proposals
Microtiter
Plate Antigen-Down Sample Proposals
Microtiter
Plate Competitive Inhibition Sample Proposals
Rapid
Test Sample Proposals
If
you would like ICT to prepare a detailed quote for
your specific project, we will spend several hours
doing a feasibility study and creating an assay
development plan for $500-$2000. If ICT develops
the kit for you, we will apply this fee to the
cost of development. Give us a call and we’d be
happy to discuss your project and determine if a
feasibility is even necessary. Please review our Assay
Development Questionnaire and call
1-800-829-3194.
Manufacturing
When the assay is
completed, reagents for 25 immunoassay kits will
be provided. They can be supplied as individually
packaged kits or in bulk packaging. When stored at
2o-8o C, each kit will have
a shelf life of at least 6 months. If you
need more kits, ICT will manufacture the
components as you order them (this usually
requires a 3-6 week lead-time). Once developed,
the cost for additional kits typically ranges from
$50 to $300 each (with a minimum manufacturing
charge of $2,000). This price will be
determined during development and depends on the
expense of the kit components, the type of
packaging required, and the volume ordered. If
you will be testing samples at different
locations, we can ship the finished assay kits
directly to the other laboratories. If the
assay has a commercial application, ICT can
private-label the test in kit format so it can be
marketed by your organization or through a
distribution partner (immunoassay kits retail
between $150 - $1,500 each). With the development
of a rapid strip test, anywhere from 100 to 10,000
tests are provided at the end of the project; the
cost for manufacturing may range between $0.50 -
$5.00 USD per test after that.
Packaging
ICT can arrange for
boxes, vials, and containers, and will include the
costs of these components in our quotes. As labels
vary considerably in look and price, the cost of
labels (and their design) is not reflected in most
quotes. However, we do include the cost of generic
labels and labor for printing lot information,
sticking them onto the components, and packing the
kits. If you already have some type of label or
package format in place that you use on other
products, you may want to continue with that
presentation. You can supply these components to
ICT, or have us purchase them directly. We can
continue to use your design (if you already have
one), or have our designers create a packaging
system.
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Total Development and Manufacturing Costs per Kit
With a development and
manufacturing order for 1,000 kits, it may cost
$30,000 to develop the assay, $30,000 for the
monoclonal and polyclonal antibodies, and $100 per
kit for continued manufacturing (1,000 kits * $100
each = $100,000). All totaled, you would initially
receive 1,025 kits for $160,000, which calculates
to $156.10 per kit.
Number of Samples and Cost per Sample
Based on an initial
manufacturing run of 1025 kits for $160,000, if 25
samples are tested in triplicates on each 96-well
microtiter plate, 25,625 samples can be tested
overall, which calculates to $6.25 per sample for
materials. If 40 samples are run in duplicates per
plate, 41,000 samples can be tested at $3.91 per
sample.
Timelines
Another issue, of course, is
time. It takes 4-8 months to develop a kit.
If antibodies are not available for use in the
kit, it will take an additional 3-6 months to
generate antibodies, and
cloning and expression of the antigen may take an
additional 4-8 months if antigen is not available. (ICT
will contract out cloning & expression
services.) Once developed, kits will be
manufactured as ordered, often just requiring a
3-6 week lead time, depending on volume. More
time may be needed for extensive validation
procedures, to create specific documentation, and
to comply with government regulations if
applicable (e.g., 510k submission).
Kit
development, if the antibodies and antigen are
available......4-8 months.
Antibody development, then kit
development.........7-14 months.
Antigen expression, antibody development, then kit
development.....11-22 months.
Other Services
We can also handle the
development of monoclonal and polyclonal
antibodies for the kit, as well as purify and
conjugate them (see Purification
). ICT
also offers consultation and a line of diluents
and reagents to help you make your own assay (see
ELISA Solutions).
Consultation
If you have questions with any immunochemistry project, Immunochemistry
Technologies can help you by offering our
scientific expertise as consultants. Through
our extensive experience in immunoassay
development, we can provide current information
and important insights into assay methodologies
and related immunochemistry topics. If you have
high backgrounds, we may have a tip to solve the
problem; or an ELISA buffer that may help. Just
call us at 1-800-829-3194 for some quick help.
For
extensive consultation projects, ICT can provide a
quote of estimated time and expenses and will
negotiate a specific payment schedule with each
customer. ICT generally charges $250 an hour for
consultation with a 4-hour minimum fee paid in
advance ($1,000). Clients are billed in 15-minute
increments.
Background Information on ELISA Technology
For more detailed information and techniques on
ELISA technology, please visit our other website
pages:
What
is an Immunoassay and what is the History of the
technology?
What
are the Typical Components in an Immunoassay Kit?
How
do I run an Immunoassay?
How
Do I Coat Plates?
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