Custom molecular diagnostic and immunoassay contract development & manufacturing
MDG, your European IVD partner
MDG (Molecular Diagnostic Group) along with its German subsidiary, Biotype, is specialized in developing and manufacturing in-vitro diagnostic (IVD) products especially molecular diagnostic and immunoassay solutions. Thanks to our US and German locations, we are helping US IVD companies to rapidly access the European IVD market by offering a wide range of solutions.
Molecular and immunological diagnostic service provider
Biotype in-vitro diagnostic is a fully integrated CDMO specialized in molecular diagnostic and immunoassay of RUO, prototypes and IVD products. Biotype offers custom development and manufacturing services of a wide range of solutions for the detection and/or quantification of DNA, RNA and biomarkers.
EU-Compliance – Fully compliant with new EU IVDR (European in-vitro diagnostic regulation 2017/746)
Our QMS (Quality Management System) meets the requirements of the national and international norms ISO 9001 and ISO 13485 for the sales, development, manufacturing and services of molecular tests for research and in-vitro diagnostic applications.
• Application & CE Registration
• IVDR support
Operations – We have mastered each step of the process to launch products on the European market in a rapid and cost-effective way
Global project management through a dedicated team of in-vitro diagnostic scientists, EU IVDR quality and regulatory experts as well as European IVD sales managers. Our Custom Solutions Team will be there from first contact to delivery of your product.
• Pre and Post PCR reagents
• Liquid or lyophilized (various volumes from 5ul to 100 ml in tubes, strips, plates or bottles)
• Scalable production
• Modern facilities
• Raw materials procurement/supplier network
• Quality control
• Storage and logistics traceability
• Stability and transport studies
• Manual or high throughput automation (10 to 24,000 vials/day)
• Kit assembly
|Flexible scale format:
• Small and large batches
• Labelling to align with your corporate identity
Development – The standard workflow includes a feasibility study, optimization phase, and validation
Fully equipped to manufacture IVD Buffers, Primer Mix, Positive controls, Enzymes, Size and Matrix Standards in state-of-art laboratories (Biosafety level BSL-2, Genetic Engineering Safety Level (S1), Clean room (Class C). Our facility design allows a unidirectional workflow to minimize in process contamination risks and follows the rules of good laboratory practice (GLP).
• Assay validation
• Full range of biomarkers and flexible platform technologies
• Analytical and Clinical performance studies
• Robust testing and performance evaluation
Commercialization – Our broad experience encompasses production of a marketable CE-IVD and ensures efficient and smooth market entry
With more than 100 collaborators, the company based in Dresden is producing hundreds of IVD reagents and molecular diagnostics kits per year in various applications: oncology, infectious diseases, forensics, and veterinary.
• Supply chain management
• Collaboration networking
Expertise – Extensive experience in the field of PCR molecular diagnostics and in-vitro diagnostics
With over 20 years’ experience, we have successfully positioned ourselves as trusted providers of state-of-the-art solutions for molecular diagnostics in Europe.
|• Trustworthy & reliable communication
• Flexibility and rapid implementation
• High commitment
Our subsidiary, Biotype, is based in Germany which is the largest in-vitro diagnostic market within Europe. This central position in Europe is ideal for developing the global European market efficiently. Thanks to our senior business development team and European IVD distributor network, we ensure a fast commercialization of molecular and immunoassay in-vitro diagnostic kits and reagents.
Get onboard and have a safe journey to Europe with MDG!