Production

Coating of membrane components 

Instead of master sheets or complete LFA cassettes, we offer our customers the opportunity to coat specific membrane components with our BioDot dispensing platforms. It is possible to apply lines using cannulas,  Spraying solutions with airjet units or saturating entire membrane zones with solutions. All variants can be offered as reel-to-reel coating with up to 100 m per roll. Upon request, the membrane components can then be positioned on self-adhesive surfaces and cut to size as a master sheet.

Lyophilization of chemical products

The Senova has several freeze-drying units and can dry products on both a development and production scale.

With the largest existing drying system, the lyophilization of 1500 vessels with a filling volume of up to 2 ml per run is currently possible. Contact us to discuss custom drying process requirements.

Conjugation of bioreagents with nanomaterials or crosslinking of bioreagents

The conjugation of antibodies and nanomaterials is an essential step in the production of lateral flow assays.

Senova therefore also offers contract conjugations of bioreagents to different nanomaterials, for example based on gold or silica particles. We can also implement customer-specific conjugations of multiple bioreagents based on different coupling reactions. Since there is a wide range of possibilities in this topic, please contact us directly in order to find an efficient solution strategy for your conjugation request.

Production of LFA functional samples

Depending on which test is to be produced, full production capacity is not always required. If batch sizes of < 8,000 cassettes are required, we take over production with smaller BioDot dosing platforms.

The membrane components are manufactured individually in 30 cm units and installed as master sheets. Depending on whether master sheets or completely assembled cassettes are required, the implementation can be adjusted. Please note that the price per test for the functional samples can differ significantly from the price for large production batches, as the functional samples involve significantly more effort due to personnel costs.

Measurement of nanomaterials and dispersions with ie 1nm to 10 µm

The production of nanomaterials requires extensive quality controls regarding the required product properties. In the case of spherical nanoparticles, the hydrodynamic diameter, the polydispersity and the surface charge of the particles play a fundamental role.

All nanoparticles produced by Senova are checked for the above properties with a Malvern Zetasizer Advance Ultra red label. The size determination is based on the measurement of dynamic light scattering (DLS) and the surface charge is determined by measuring the zeta potential. The measurements can be carried out for almost all types of nanomaterials and are particularly suitable for quality control with the data sheets we have prepared.

We gained our greatest experience with the measurement of nanomaterials. If you have other dispersions, for example from the food, dye or cosmetics industry, we can carry out preliminary tests for you in order to then plan the measurements using established protocols.

Conducting seminars and workshops on the topic of lateral flow assay

There is numerous development work on lateral flow assays within the IVD industry and often there is still potential for optimization even after development has been completed because certain aspects were not taken into account or even ignored. As experts in lateral flow assays, we share our experience from over 20 years of assay development in the form of lectures and workshops.

At these events, there will be presentations on solutions to problems in test development as well as important content in the validation and IVDR-compliant approval of IVD products. We announce planned workshops on our website well in advance; individual appointments can be arranged for lectures or seminars.

Senova offers a model assay that can be used for training purposes or exercises. The LFA specifically recognizes a model antigen that does not occur in nature. The type of sample application can be chosen variably. The antigen solution can be applied directly with a pipette under ideal conditions, or sprayed onto a surface and then picked up with a swab and transferred into a buffer solution.

Design and pilot production of test housings and test components using 3D printing

The test housing and the sampling components included in the test kit form the interface between the user and the test strip and sometimes place high demands on functional and design issues.

Senova can look back on over 15 years of experience in the development of strip tests and associated test housings and has its own test cassette series on which more than 15 clinical tests are currently adapted. We would be happy to accompany you through all levels of test housing development; from the initial design idea, to the conception and integration of functional elements, the production of technical drawings, the high-resolution prototype production using the 3D printing process, the transfer to production scale to the automated laser marking of the finished product. We also have extensive experience with joining techniques and assembly strategies in the context of large-volume production (injection molding).

We would be happy to put you in touch with our industrial partners for production transfer.

Products bei Senova

At the Weimar location, our partner Senova covers all components required for the production of in-vitro diagnostics based on lateral flow technology. As an EN DIN ISO 13485:2016 certified service provider, we offer our customers both individual components and customer-specific materials through to ready-to-sell diagnostic kits made in Germany.


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