Takara Bio—your partner for better clinical test and kit development

Our quality management system has received a certification specific for medical devices and related services under ISO 13485:2016. The ISO certification demonstrates our commitment to quality and to all our customers benefiting from using Takara Bio products around the world. We can provide a copy of our certification upon request. 

Yes, we can supply higher concentrations of most enzymes in our catalog. The specific concentrations vary by enzyme and buffer formulation, but we will work to provide a solution that meets your requirements.  

Yes, Takara Bio's trusted manufacturing capabilities include our ability to provide custom components, as well as labeling and packaging solutions, for your kits. We will work with you to define your configuration, formulation, and specific packaging requirements in order to recommend the best possible solution. Our professional design team will then create high-quality logos and images that meet your high standards. 

We have over 40 years of experience in designing products created specifically for our customers’ research needs. We work closely with you to understand your product requirements so we can develop a product that meets your needs. We will assemble a dedicated project team consisting of project management, R&D, Operations, and QC to work alongside your R&D team to develop an enzyme that is compatible with your assay design and platform.

We start by working with your R&D team to develop the appropriate materials and protocols. After transferring the product to manufacturing, we will work on scale-up and validation. We provide samples for you to test, and, upon approval, we proceed from R&D to operations to manufacture a verification batch. Once the verification batch is approved, we will move to a production-scale batch to provide you with a sample to test. The result will be a custom enzyme that meets your objectives, saving you time and development costs. 

Yes. Our team of development scientists gets involved early in the project planning and development phases to advise on the manufacturing and quality control testing required for a custom product. We perform functional testing on all our enzymes and can provide guidance on the type of functional testing required. If required, we will work with you to design customized quality control testing that fits your desired specifications and provide guidance on recommended testing and documentation. We will generate a customized certificate of analysis that reflects your unique catalog numbers, lot numbers, and the pass/fail criteria that you require. Additionally, we will also provide any technical information related to your custom enzyme such as a user manual, SDS, and quality documentation. 

Yes, we can provide multiple small-scale and/or production-scale lots for evaluation or validation. 

Yes, we routinely work with groups operating in multiple regions and can coordinate shipping, inventory, and logistics. Takara Bio has manufacturing capabilities in six countries and six distribution centers globally. Our primary distribution center in Madison, WI, USA, supports our global locations and distributors. We will work with you to ensure timely delivery to any region required. 

Our goal is to reduce your time to market, and the lead time will depend largely on your criteria or requirements. Contact us at the earliest stage possible. Starting the partnership early can help define criteria for success quickly and identify key contracts, R&D, operations, and manufacturing actions that may be necessary in delivering your custom-tailored solution that meets all your validation requirements. Once these aspects are agreed upon, an accurate lead time can be provided.

Our expert scientists can provide technical insight on experimental design and optimization, which will save you time and development costs. Our team will consult with you and discuss your specific assay requirements related to your sample type, buffer composition, amplicon size and complexity, reaction volume, and other parameters. Based on this information, we will recommend an optimal enzyme/buffer system that fits the precise specificity, sensitivity, and workflow requirements of your diagnostic assay.

You can request a sample of one of our high-concentration or glycerol-free enzymes by contacting us. We also have sample sizes of many of our catalog products. Alternatively, you can request a sample by contacting your local Territory Manager.