CONTRACT DEVELOPMENT AND MANUFACTURING SERVICE OFFERING (CDMO) FREEZE DRYING MOLECULAR DETECTION TESTS

A COMPREHENSIVE AND INTEGRATED SERVICE OFFERING

Building on its success in animal health, Enalees offers its expertise in the development of molecular detection kits by genetic amplification (PCR & NAAT Nucleic Acid Amplification Tests) as well as its know-how and production and freeze-drying equipment to support you in your genetic analysis projects.

A ONE-STOP SHOP WHATEVER YOUR INDUSTRY

Whether you are in health, the environment, the agri-food sector, or in biotechnology, our dedicated project team will support you in the approach best suited to your needs: a global or partial innovative solution (development and/or manufacturing and lyophilization).

Our development and manufacturing/preservation solution will allow the rapid and accurate detection of pathogens or genetic material. For example, we can help you to develop and manufacture diagnostic tools to assess the presence of any pathogens in human biological matrices.

KNOW-HOW IN DEVELOPMENT

Our team of Ph.Ds, engineers and technicians has developed more than 60 infectious disease diagnostic kits using LAMP (Loop-mediated isothermal AMPlification) technology for our animal health business and for third parties.

This isothermal amplification retains the benefits of PCR (specificity and sensitivity) while combining rapid results (30 minutes) and robustness.

From sample preparation (DNA/RNA extraction), in our level 2 biosafety laboratory, to primer design, prototyping and optimisation of the freeze-drying protocol, right up to the determination of detection limits, Enalees will support you in your project to develop your molecular detection tests.

FREEZE-DRYING: A PROVEN PRESERVATION PROCESS

Freeze-drying consists of removing the maximum amount of water from a product, without altering its properties, in 4 key steps:

Freezing

Freezing the product.

Primary drying

Primary drying.

Secondary drying

Desorption.

Sealing

Sealing and capping of the lyophilised product.

Freeze-drying is a conservation process used in many industries because its advantages are well established: preservation of the properties of freeze-dried reagents, conservation of the finished product at room temperature, ease of use. It is for all these reasons that Enalees has been using this process for its own veterinary diagnostic products since 2018.

HIGHLIGHT ON OUR PRODUCTION EQUIPMENT

8 pipetting robots
2 industrial freeze dryer
4 pilot lyophilisators
3 sealing machines
Microbiological Safety Station (MSS)-3 PCR hoods
Cold storage
Equipment shared with our scientific ecosystem Genopole

Enalees assists you in the freeze-drying of your product (proteins, antibodies, enzymes, etc.): from their preparation, following your protocol, to the finished product certified by a dedicated quality team.

Our production capacity of 1 million tests per year allows us to ensure that your timetable is respected.

DEDICATED AND CUSTOMISED PROJECT MANAGEMENT

Enalees supports you step by step in your project, either for development and manufacturing as a bundle, or as separate package (development only, or for manufacturing only).

Depending on the complexity of the project, we will implement an adapted governance (steering committee, operational committee).

Here are the main steps of a standard project:

Project “discovery” meeting: we establish the project outline according to your needs.
Drawing up the specifications: we define the project specifications together.
Drawing up the financial estimate and technical protocol
Feasibility study of the project
Detection kit development phase (if required)
Production phase – pilot batch: we produce a test batch for technical validation with the freeze-drying process.
Production phase – scale-up: after your approval, we produce the main batch.
Deliverable

It is delivered to you in accordance with the specifications of the estimate.