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.

INTEGRATED SOLUTIONS
FOR YOUR CHALLENGES

Advantages You Can Trust

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.

ISO 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.

EXPERTISE YOU CAN RELY ON

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 and immunoassay-based diagnostics. We have a proven record in developing molecular and immunoassay diagnostic tests in various applications, such oncology, infectious diseases, forensics, and veterinary.

Regulatory Compliance

We actively work with you to manage project related regulatory aspects, provide guidance and help navigate the often-perplexing environment of industry regulations.

SOLUTIONS YOU CAN CHOOSE

Platform Flexibility

We provide a wide range of molecular diagnostic and immunoassay 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
PROJECT TEAM

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.

Biotype Custom Solutions Project Team - Jens Frerichs

Jens Frerichs

Business Development
Manager

Biotype Custom Solutions Project Team - Dr. Kathleen Clauß

Dr. Kathleen Clauß

Liaison Manager
Custom Solutions

Biotype Custom Solutions Project Team - Dr. Manja Böhme

Dr. Manja Böhme

Head of
Custom Solutions

Biotype Custom Solutions Project Team - Jana Goss

Jana Goss

Head of
Regulatory Affairs

Biotype Custom Solutions Project Team - Dr. Kerstin Korn

Dr. Kerstin Korn

Head of Operations
and Project Management

Biotype Custom Solutions Project Team - Dr. Christoph Schanzenbach

Dr. Christoph Schanzenbach

Head of Applied Research

Biotype Custom Solutions Project Team - Jana Hahm

Jana Hahm

Head of
Development

Biotype Custom Solutions Project Team - Alin Schwarz

Alin Schwarz

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.

Project Definition

CUSTOMER REQUEST

Acknowledging your needs and demands

Project Definition

PROJECT DEFINITION

Building a multidisciplinary project team of experts that will determine a complete solution, timeline, and appropriate technologies

Contract Development

CONTRACT DEVELOPMENT

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

Contract Manufacturing

CONTRACT MANUFACTURING

Manufacturing at different scales: small or large batches

Validation

VALIDATION

Clinical validation of the specificity and sensitivity of your product

Custom Packaging

CUSTOM PACKAGING

Customized packaging of your product

Technical Support

TECHNICAL SUPPORT

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.

Pyrosequencing

Gel Electrophoresis

Lateral Flow

Elisa

qPCR

Capillary Electrophoresis

Digital PCR

Sanger / NGS Sequencing

Modaplex

Exclusive Technology

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

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 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

CONTRACT MANUFACTURING

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

Custom Packaging

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

Quality Management

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

Regulatory Consultance

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

Consumables

  • 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

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

“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

Biotype Custom Solutions Project Team - Jens Frerichs

Jens Frerichs

Business Development Manager

+49 351 8838 414

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