Custom Solutions
Contract development & manufacturing
of molecular diagnostic tests
BIOTYPE’s contract development & manufacturing service covers all challenges from the idea up to the realization of a marketable product. As a European Molecular Diagnostic company and a proven OEM supplier, we are committed to high-quality standards and can accommodate individualized product specifications for our international customers.
BIOTYPE Custom Solutions
YOUR One Stop Shop for CDMO Services
Contract Development
- Expertise in molecular and in vitro diagnostics
- Modular development following Design Control Guidelines from idea to CE-IVD market
- Advanced bioinformatic analyses with machine learning and AI for diverse biomarkers
- Adaptable biomarkers and platform technologies
Multiplex Assay Development
- Multiplex primer and assay design
- Assay condition testing and enhancement
- Analytical performance testing
- Clinical performance testing
- Assay manufacturing and ready-to-use delivery
Contract Manufacturing
- Customizable and cost-effective manufacturing, manual or automated
- Adaptable batch sizes under clean room conditions following GLP guidelines
- Efficient supply chain management
- Robust quality control oversight
Custom Packaging
- Tailored packaging design and production
- Customized scale, format, and labeling options
- Alignment with your corporate identity
- High-quality materials from certified suppliers
Regulatory Consultancy
- Regulatory support from idea to marketable product
- Establishment and recording of all required documentation
- Application and CE registration
Quality Management
Our quality management system that fulfills the requirements and the recommendations of the international norms DIN EN ISO 9001 and 13485 or the sales, development, manufacturing, and services of molecular tests for research and in-vitro diagnostic applications.
“Since 2009 Biotype has delivered high-quality materials that consistently meet our high demands in contract manufacturing. Thanks to Biotype, our long-standing OEM service partner for forensic applications.”
“Starting the cooperation with Biotype in 2013 the successfully joint development of DNA based Lateral Flow Stripes was the most important step to further develop this technology for our company.”
“In 2022, we started the pilot production of the first CE-marked IVD assay for the measurement of NAD metabolites in human blood together with BIOTYPE. We are highly satisfied with BIOTYPE's professional, always solution-oriented approach, which has ensured rapid progress while maintaining the highest quality. In addition, their location in the heart of continental Europe secures efficient distribution and easy availability of NADMED kits around the world.”
"We are grateful for BIOTYPE's critical role in verifying and transforming our WID®-easy PCR assay into a commercially available product.Their data-driven approach, expertise and quality control have been critical to our success and have ensured the accuracy and reliability of our product. We look forward to continuing to work together to make a difference in women's health worldwide.”
Our Partners
Contact
Reach out to the BIOTYPE Custom Solutions team for your new project
