Development and production of immunoassay
BIOTEM offers cutting edge services for the development of custom ELISA and Lateral Flow ImmunoAssay (LFIA) for the detection and quantification of analytes.
With more than 30 years of experience and a strong expertise, BIOTEM proposes contracts with guaranteed results for the development and validation of your test.
During the preliminary phase BIOTEM and the Client performed and in-depth analysis and validation of:
- Test specifications
- Biological material available
- Project success criteria
At the end of this phase BIOTEM will propose/recommend one or several strategies for the project development.
- Analytes to be detected /quantified
- Type of test
- Performance and analytical characteristics
- Matrix (Blood, Saliva, Urine, Serum, etc.)
- Specific constrains
- Antibodies (Polyclonal or Monoclonal)
- Reference samples / Reference assay methods
- Robustness of sample preparation methods
- Storage and stability of the biological components
Lateral Flow tests (immunochromatography system assays) are based on the migration of nano or micro particles on strips for analytes detection in several areas:
- Human and animal diagnostics Point of Care testing (PoC)
- Industrial QC
- Forensics, biowarfare, etc.
- Environmental testing
- Rapid test (<15 minutes)
- Reliable and easy-to-use (no special equipment required nor trained staff)
- Semi-quantitative or quantitative results
- Non-refrigerated storage
- Economical industrial production
- Simultaneous measurement of a large number of samples
- Duration : 30 minutes to several hours
- Quantitative results
- Optimal limit of detection
- Reliable and robust
The feasibility study is the first experimental step of the development process during which BIOTEM evaluates and selects the best components available (antibodies, antigens, membranes, conjugates, etc.). BIOTEM initiates the development of different prototypes according to the development strategy previously defined.
Finally, BIOTEM will propose a development contract with guaranteed results or resources commitments (see below).
The Client and BIOTEM define together a contract containing:
- Success criteria definition
- Validation methods
- Success fees clause (payment in case of success only)
Guaranteed results contract is the best commitments that BIOTEM is proud to propose to its Clients which reflects BIOTEM’s excellence.
In occasional cases, it will not be feasible to offer results commitments (mostly when success criteria cannot be clearly defined). The test development will then consist of a series of intermediary phases (each with a set duration) during which BIOTEM allocates especially dedicated resources.
BIOTEM will send intermediary phases reports including the results and further development work suggestions. After a discussion with BIOTEM, the Client decides on the continuation of the project (GO/no GO).
- Human Health
- Animal Health
- Industrial Control Quality
- Bio Warfare
- Small Molecules
- Development of high quality monoclonal antibodies
- Exclusive conjugation technologies and antigen preparation
- Optimised tracers
BIOTEM optimises prototypes initially developed during the feasibility study. During this phase several validations of the prototypes are undertaken in order to ensure that the development is in line with the project specifications.
Regular contacts with our technical team guarantee the best conditions for BIOTEM to support customers in their project development.
BIOTEM and the Client jointly carry the formal evaluation (laboratory or field trials) of the performance and the several characteristics of the test. This validation phase is performed to meet Client’s specifications.
- Limit of detection
- Linearity / Parallelism
- Inter- and Intra-assay reproducibility
- Stability studies of the test and its components
- Transfer of technology to the Client or Client’s manufacturer
- Industrialisation and batch production
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