CONTRACT DEVELOPMENT & Manufacturing for Molecular Diagnostics
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 are able to accommodate individualized product specifications for our international customers.
FOR YOUR CHALLENGES
Advantages You Can Trust
Expertise You Can Rely on
Solutions you can choose
Dedicated Project Team
For each contract development and/or manufacturing project, we assemble a multidisciplinary team of experts that accompanies you throughout your individual project.
Transparent Project Management
Project goals and timelines are jointly set, and you will be regularly updated of our progress during web-based or on-site progress meetings.
Our quality management system fulfills national and international norms (ISO 9001 and ISO 13485) for the development and the production of molecular biological diagnostic tests.
Research, Development, Manufacturing
You can rely on a company that brings over twenty years of expertise in research, development, and manufacturing of in vitro diagnostic (CE-IVD) products.
Diversity in Indications
Benefit from our expertise in the diverse fields of molecular diagnostics. We have a proven record in developing molecular diagnostic tests in various molecular applications, such oncology, infectious diseases, forensics, and veterinary.
We actively work with you to manage project related regulatory aspects, provide guidance and help navigate the often-perplexing environment of industry regulations.
We provide a wide range of molecular diagnostic platforms for the detection and quantification of biomarkers at various levels of multiplexing.
Complete IVD Realization or Elements
Biotype addresses all the aspects of product development and manufacturing, right from the idea to the large-scale production of a marketable CE-IVD. You decide whether you want us to support you throughout the entire process or only during certain steps and phases of the product life cycle.
Small- / Large-Scale Requests
Your project scale is entirely customizable. With our Contract Manufacturing services, we provide small batches for clinical studies or large batches for international commercialization. With our Contract development services, we accommodate for small or large sized projects.
YOUR CUSTOM SOLUTIONS
Biotype acknowledges the molecular diagnostics’ market demands. Together, we consider the needs of your project and provide the best technology for the job. Our Custom Solutions Project Team will guide you throughout the entirety of the project from first contact to the delivery of the finished goods.
Business Development Manager
Dr. Kathleen Clauß
Dr. Manja Böhme
Dr. Kerstin Korn
Head of Operations and Project Management
Dr. Christoph Schanzenbach
Head of Applied Research
Head of Contract Manufacturing
YOUR INDIVIDUAL WORKFLOW
Biotype services cover every step right from the idea to the marketable product. No matter how creative or demanding your ideas are, Biotype’s transparency and clear-cut workflow will guide you to the required product: Prototype, RUO, or CE-IVD.
Acknowledging your needs and demands
Building a multidisciplinary project team of experts that will determine a complete solution, timeline, and appropriate technologies
Developing the product according to your needs: Prototype, RUO, or CE-IVD
Manufacturing at different scales: small or large batches
Clinical validation of the specificity and sensitivity of your product
Customized packaging of your product
Continued support throughout the life cycle of your product
MOLECULAR DIAGNOSTIC TECHNOLOGIES TO MEET YOUR NEEDS
We provide a wide portfolio of platform technologies for the detection and/or quantification of DNA, RNA and immunological biomarkers.
Sanger / NGS Sequencing
The proprietary Modaplex technology merges the Polymerase Chain Reaction (PCR) and Capillary Electrophoresis (CE). This automated platform allows simultaneous quantification of up to 50 parameters.
PRODUCT REALIZATION ACCORDING
TO YOUR REQUIREMENTS
We develop your idea into a marketable product, no matter how creative or demanding your ideas are. Our development process is modular; CE-IVD development can be paused at the Prototype or the RUO stage, providing you with flexibility while developing a molecular diagnostic (MDx) test.
- Extensive experience in the field of PCR molecular diagnostics and in-vitro diagnostics
- Bridging Studies and Assay & Workflow optimization
- Various types of biomarkers
- Flexible use of platform technologies
- State-of-the-art laboratories with (Biosafety level BSL-2 and Genetic Engineering Safety Level (S1)
- Development processes following Design Control Guidelines
- Start with small projects to minimize risks
Production at Biotype takes place within well-equipped modern facilities, which include clean rooms, quality-control laboratories, and state-of-the-art equipment. Our facility design allows a unidirectional workflow to minimize in process contamination risks and follows the rules of good laboratory practice (GLP).
- Customized and cost-effective manufacturing processes (manual or high throughput automated)
- Batch sizes to meet your needs (small and large scale)
- Flexible formats (Bulk ware or dispensed)
- Physical separation of Pre- and Post PCR reagent production
- Production under clean room conditions
- Batch-related stability monitoring
- Supply chain management
- Whole-process quality control
We can design and produce custom packaging for your products. Through an interactive design process, we assure you that the boxes, labels, inserts, and user manuals meet all the regulatory requirements and that their design is aligned with your corporate identity.
- Individual scale, format, and labeling
- Aligned with your corporate identity
- High-quality materials from certified suppliers
- Stability and transport studies
Biotype GmbH has established an integrated quality management system that fulfills the requirements and the recommendations of the international norms DIN EN ISO 9001:2015 and 13485:2016 for the sales, development, manufacturing, and services of molecular tests for research and in-vitro diagnostic applications.
- ISO 9001 Certificate
- ISO 13485 Certificate
Our broad experience in international regulatory affairs in the field of in vitro diagnostics ensures efficient and smooth market entry. Biotype guides you through the certification process framed by the 98/79/EG directive governing in vitro diagnostic medical devices.
OEM PRODUCTS AND SERVICES
Biotype serves as an original equipment manufacturer for PCR related reagents and consumables. Use our proprietary reagents and integrate these in your workflows and kits.
References and Size Standards
- Allelic ladders for precise genotyping for capillary electrophoresis
- DNA ladders for precise DNA-sizing for capillary electrophoresis
- Patented matrix standards for capillary electrophoresis
- Proprietary Hot Start Taq Polymerase
- Proprietary PCR buffer systems
- Quality Controls (Control DNA, plasmids)
- Quality Sensor for internal control of DNA isolation, amplification, and PCR inhibition
- Sampletype i-sep® sample preparation and DNA extraction system for medical and forensic labs
- Sampling sets for send-in laboratory services
- Proprietary software for easy interpretation of raw data from (q)PCR-platforms
- Proprietary Laboratory Information Management System (LIMS/lab book)
- Our proprietary software can be connected to your existing software platforms and devices