Austrian diagnostics company seeks contract manufacturer for In Vitro Diagnostic test kits

TechnologyRakúskoTRAT20200331001
Requests
Summary: 
Vienna-based diagnostics service provider seeks company to design, assemble and package in-vitro diagnostic (IVD) test kits for a proprietary product. Assay development is concluded and relevant product specifications are in place. The cooperation partner needs all required permits and expertise in designing, packaging, assembling and validating the kits. Support is needed for labelling and preparing the required documentation. They seek a partner for manufacturing agreement within Europe.
Description: 
The company was founded in 2012 as a spin-off of a renowned Austrian biotech company. They possess a globally unique proprietary technology for the molecular characterisation and assessment of specific peptides, which play a key role for the regulation of blood pressure, water balance as well as acute and chronic inflammation. This novel technology is used to enable a more targeted therapy to treat high blood pressure or to newly develop such medications by rational design. The company already offers its technology as in-house analytical services to worldwide customers and now wants to expand its portfolio to diagnostic test kits so that customers/laboratories are able to apply the technology directly. Therefore, the company is looking for an experienced partner for manufacturing of the test kits and preparation of the necessary documentation in German and English. The test will comprise well plates, liquids and a chromatography column (Original Equipment Manufacturer, OEM). All items and reagents will be ordered by the company and delivered directly to the assembling and manufacturing partner. The specifications of the columns are secret knowledge and therefore they will be provided by the company itself. Compliance with the applicable statutory and regulatory requirements (In Vitro Diagnostics Regulation, IVDR) is an absolute must. Commercialisation of the test kits may be conducted jointly by both companies, provided the manufacturing partner already possesses an international network, but this is not a must. Commercialisation by the seeking company only is also possible. The envisaged end users are laboratories / lab groups worldwide which will offer the analysis as a service to their own customers. In principle, all laboratories / lab groups offering blood tests of any kind and having a mass spectrometer LC-MS/MS at their disposal, may be able to offer these test kits. In the launch phase, the production volume will be about 200 test kits in total. Depending on monthly sales the production will be augmented accordingly. The basis of the cooperation will be a manufacturing agreement with a small or medium-sized company established in Europe, preferably but not limited to the DACH region (Germany, Austria, Switzerland). All the relevant know-how regarding the technology of the assay will be transferred to the manufacturing partner.
Type (e.g. company, R&D institution…), field of industry and Role of Partner Sought: 
Manufacturing agreement: The company has developed an innovative assay for the molecular characterization and assessment of specific peptides. The technology developed will be transferred to the partner together with relevant expertise and know-how in order to enable the partner to manufacture respective test kits. The company is looking for an experienced partner in IVD test kit manufacturing. Compliance with applicable statutory and regulatory requirements (IVDD (In Vitro Diagnostic Directive) and in the future IVDR) is an absolute must. The kit manufacturer should be ISO 13485-certified. The partner should be a small or medium-sized company preferably located in the DACH (Germany, Austria, Switzerland) region, but this request is not limited to it.
Technical Specification or Expertise Sought: 
In detail, the following expertise and tasks are required from the cooperation partner: - IVD packaging configuration (box, cartons and tray design) including box closure, containers and packaging accessories - Drafting the required labels and documentation (instructions for use, safety data sheets, etc.) - Assembling of the kits by complying with applicable regulatory (IVDR) and safety requirements; Preferably, the kit manufacturer is equipped with a liquid chromatography-mass spectrometry (LC-MS/MS) device and is ISO 13485-certified.
Stage of Development: 
Already on the market
Comments Regarding Stage of Development: 
The test is already offered as in-house analytical service to customers worldwide.
IPR Status: 
Patents granted
External code: 
TRAT20200331001