Your Premium Service Provider for

Development, Manufacturing, and Validation of Genetic Tests

We are the PCR Experts

Sensitive and Specific Detection
of Multiple Genetic Markers

Molecular Diagnostic solutions

Biotype’s premium contract development & manufacturing service covers all challenges from the idea up to the realization of a marketable Product. As an international biotechnology company and a proven OEM supplier, we are committed to high-quality standards and are able to accommodate individualized product specifications.

Integrated solutions for your challenges

Advantages You Can Trust

Advantages

Personalized Project Team

For each OEM-project, we assemble a multidisciplinary team that accompanies you throughout the entirety of the 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.

Certified

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.

Experience You Can Rely on

Experience

Research, Development, and Manufacturing

You can rely on a team that brings almost twenty years of experience in research, development, and manufacturing of in vitro diagnostic (CE-IVD) products.

Diversity in Indications

Benefit from our experience in various indications, such as pathogen detection, oncology, forensics, and veterinary.

Regulatory Competence

Development is performed according to FDA Design Control Guidance for medical devices (FDA Quality System Regulation 21 CFR Part 820).

Solutions You Can Choose

Solutions

Flexibility in PCR Platforms

We provide a wide range of PCR platforms for the detection and quantification of DNA and RNA targets at various levels of multiplexing.

Complete IVD Realization or Elements

Biotype addresses all the aspects of product development, 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.

Small-Scale or Large Batches

Regardless if you need small batches for clinical studies or large batches for international commercialization we provide scalable production capabilities.

YOUR Personalized Project Team

Biotype understands what it takes to get a product to the market. We know about the demands of PCR diagnostics and life science. Together, we consider the needs of your project, select the best technology for the job, and guide you throughout the development process.

Dr. Kathleen Clauß

Key Account Manager
B2B

Dr. Joeri Kint

Head of Product Management
B2B

Dr. Kerstin Korn

Head of Scientific Affairs Project Management

Dr. Manja Böhme

Head of Development Project Management

Dr. Werner Brabetz

Head of Intellectual Property and Regulatory Affairs

your individual Workflow

The Biotype OEM service covers 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.

CUSTOMER REQUEST

Listening to you and understanding your needs

PROJECT DEFINITION

Building a multidisciplinary project team, determining a complete solution, timeline, and appropriate technologies

CONTRACT DEVELOPMENT

Developing the product according to your needs: Prototype, RUO, or CE-IVD

CONTRACT MANUFACTURING

Manufacturing at different scales: small or large batches

VALIDATION

Clinical validation of the specificity and sensitivity of your product

CUSTOM PACKAGING

Customized packaging of your product

TECHNICAL SUPPORT

Continued support throughout the life-cycle of your product

CUSTOMER REQUEST

Listening to you and understanding your needs

PROJECT DEFINITION

Building a multidisciplinary project team, determining a complete solution, timeline, and appropriate technologies

CONTRACT DEVELOPMENT

Developing the product according to your needs: Prototype, RUO, or CE-IVD

CONTRACT MANUFACTURING

Manufacturing at different scales: small or large batches

VALIDATION

Clinical validation of the specificity and sensitivity of your product

CUSTOM PACKAGING

Customized packaging of your product

TECHNICAL SUPPORT

Continued support throughout the life-cycle of your product

PCR Technologies to meet your needs

We provide a wide portfolio of PCR platforms for the detection and/or quantification of DNA and RNA.

Capillary Electrophoresis

Agarose Gel Electrophoresis

Lateral Flow

Pyrosequencing

qPCR

Digital PCR

Modaplex

Exclusive Technology

The 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

CONTRACT DEVELOPMENT

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 companion diagnostic (CDx) test.

 

  • Extensive experience in the field of in vitro diagnostics
  • Modular product development: Prototype, RUO, or CE-IVD
  • Transparent project management

CONTRACT MANUFACTURING

Production at Biotype takes place within modern facilities, which include clean rooms and quality-control laboratories.

 

  • Flexible manufacturing in different scales (small and large batches)
  • Production under clean room conditions (cGMP)
  • Long-term storage and stability testing
  • Proprietary reagents (enzymes, master mixes, standards, ladders, and controls)
  • Bulk ware or aliquoted single reactions

CUSTOM PACKAGING

We can design and produce custom packaging for your products. Through an interactive design process, we assure you that the boxes, 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

QUALITY

Biotype Diagnostic GmbH has established an integrated quality management system that fulfills the requirements and the recommendations of the international norms DIN EN ISO 9001 and DIN EN ISO 13485 for the development, production, and distribution of molecular diagnostic devices.

 

Product realization according to your requirements

CONTRACT DEVELOPMENT

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 companion diagnostic (CDx) test.

 

  • Extensive experience in the field of in vitro diagnostics
  • Modular product development: Prototype, RUO, or CE-IVD
  • Transparent project management

CONTRACT MANUFACTURING

Production at Biotype takes place within modern facilities, which include clean rooms and quality-control laboratories.

 

  • Flexible manufacturing in different scales (small and large batches)
  • Production under clean room conditions (cGMP)
  • Long-term storage and stability testing
  • Proprietary reagents (enzymes, master mixes, standards, ladders, and controls)
  • Bulk ware or aliquoted single reactions

CUSTOM PACKAGING

We can design and produce custom packaging for your products. Through an interactive design process, we assure you that the boxes, 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

QUALITY

Biotype Diagnostic GmbH has established an integrated quality management system that fulfills the requirements and the recommendations of the international norms DIN EN ISO 9001 and DIN EN ISO 13485 for the development, production, and distribution of molecular diagnostic devices.

 

YOUR GUIDE FOR REGULATORY QUESTIONS

Our broad experience with 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.

From Idea to IVD

Additional Services & Products

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

Consumables

  • Proprietary Hot Start Taq Polymerase
  • Proprietary PCR buffer systems
  • Quality Sensor for internal control of DNA isolation, amplification, and PCR inhibition

Sample Preparation

  • Sampletype i-sep® sample preparation and DNA extraction system for medical and forensic labs
  • Sampling sets for send-in laboratory services

Software Solutions

  • 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

Our Partners

What our partners say about us

“Since 2009 Biotype has delivered high-quality material that consistently meet our high demands in contract manufacturing. Thanks to Biotype, our long-standing OEM service partner for forensic applications.”

 Keith Elliott

Senior Manager Global Marketing

QIAGEN UK

“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.”

Tilmann Bur

Vice President Clinical Diagnostics

R-Biopharm

“In 2015 Biotype and Genolytic initiated the MycoTYPE Skin laboratory service. The companies interacted on a daily basis to develop and optimize the processes for the teams and the customers. It was an inspirational and successful time.”

Prof. Dr. Jörg Gabert

Genolytic GmbH, Leipzig

Contact

YOUR CONTACT PERSON

Dr. Kathleen Clauß

Key Account Manager B2B

+49 351 8838 445

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Biotype Diagnostic GmbH

Biotype Diagnostic GmbH
Moritzburger Weg 67, 01109 Dresden

info@biotype.de, Tel.: +49 351 8838 400, Fax: +49 351/8838 403

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