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.
To
help us determine an accurate quote for your
project, please review our Assay
Development Questionnaire and give us a call
at 1-800-829-3194. For
examples of pricing and time-lines for assay
development, see our sample proposals listed here,
which detail time and cost estimates.
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 receive 1,025 kits for
$160,000, which calculates to $156.10 per kit.
Number
of Samples and Cost per Sample
Based on 1025 kits, 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.
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.
Sample
Proposals
Proposals
are often broken down into 4 phases, which detail
time and cost estimates (see the sample proposals
listed here). Payments are often 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
Other
Services
If the antigen is not available, ICT offers custom
Cloning
& Expression services. We can also
develop monoclonal and polyclonal antibodies for
the kit (see Antibody
Development and Purification
). ICT
also offers consultation and a line of diluents and reagents to help you
make your own assay (see ELISA
Diluents ).
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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.
Payments
ICT charges $250 an hour for consultation with a
4-hour minimum fee paid in advance ($1,000).
Clients are billed in 15-minute increments.
For extensive projects, ICT can provide a quote of
estimated time and expenses and will negotiate a
specific payment schedule with each customer.
Manufacturing
When the assay is completed, we normally supply
customers with reagents for 25 immunoassay kits.
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 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. As any extra packaging
will increase costs, customers should decide if a
slick marketing design is necessary. If the assay
is to be used in-house, we recommend generic bulk
packaging where ever feasible.
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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