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Takara Bio—your partner for better clinical test and kit development
In today's competitive molecular diagnostic testing market, you need to be confident that your manufacturing partner can provide you with continued access to the latest technologies your customers have come to expect. Developing and performing diagnostic tests requires a supplier who can be trusted to consistently deliver reliable products and services that will help you improve efficiencies, reduce costs, streamline operations, and get your products to the market. With over 50 years of experience, plus manufacturing capabilities and distribution centers in six countries, we are well equipped to provide our market-leading products with superior inventory management and logistical support.
Leverage a market leader’s expertise
High-quality products. Scalable manufacturing. Industry-leading customer support.
A partnership with Takara Bio gives you a strong competitive advantage. Our world-class scientific and manufacturing expertise have enabled us to successfully support some of the top testing labs in the US and globally for decades. As a primary manufacturer of enzymes and reagents, we control all aspects of product manufacturing, from incoming raw materials to release of finished goods. This has enabled us to actively support numerous testing labs in receiving COVID-19 test EUAs using our standard, custom, and OEM one-step RT-qPCR kits, some of which are marked CE-IVD.
- Accelerated time to market, improved efficiency, optimum solutions
- High-quality reagents with consistent performance and reliability
- Product customization including high-concentration and glycerol-free solutions
- State-of-the-art facilities for scalable fermentation
- Flexible shipping options with on-time delivery and continuity of supply
- Robust quality systems and materials management capabilities with strict control of confidential information
Rely on our global custom manufacturing and OEM capabilities
Manufacturing in six countries. Global distribution. Sustainable packaging solutions.
As your partner, we minimize your risk associated with inventory management by providing the logistical support to meet your delivery requirements. 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. Our sustainable packaging solutions are designed to accommodate your brand requirements while optimizing ease-of-use, function, flexibility, and storage conditions during shipping and in the laboratory.
- Product development and manufacturing capabilities to deliver customer-branded products
- Custom product formulations, vialing/dispensing, labeling, and packaging
- Modified packaging to accommodate automated workflows
- Custom quality-control specifications to meet your assay QC and documentation needs
- Lyophilized or lyophilization-ready (glycerol-free) enzyme and buffer formulations
- Single-lot sourcing (for use in preclinical studies, etc.)
- Bulk supply of critical reagents used at high frequency
Count on superior quality and support
Stringent quality standards. Comprehensive quality-assurance testing. Expert support.
We have established a comprehensive quality assurance system that enables us to meet our commitment to customer satisfaction. Our rigorous quality management system meets ISO 13485:2016 standards, and cGMP for select products, to ensure your product is being manufactured to a highly consistent and reproducible standard. All our custom manufactured products are provided with proof of performance and certificates of analysis to validate specifications. Additionally, we will work with you to determine if your custom product formulation requires further quality assurance testing.
We are committed to enable you to create the best possible assays that have the biggest impact in your marketplace. When you collaborate with our team, you are getting more than just high-quality products; you are also gaining a dedicated team of experts who are ready to provide support at every step of your product's life cycle. You can rely on our broad range of enzyme products, expertise, and services to provide superior solutions that meet your customer's needs.
What quality system does Takara Bio USA, Inc. fall under?
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.
Can I request an enzyme at a higher concentration than what is available for the standard catalog product?
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.
Can you package a custom enzyme under my brand, either as part of a kit or standalone?
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.
What is the process for custom enzyme or formulation development? What if I require a custom enzyme formulation that's not in your portfolio?
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.
Can you perform specialized quality control, functional testing, and documentation for the custom enzyme according to my specifications?
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.
Can you provide multiple lots of custom enzymes for testing?
Yes, we can provide multiple small-scale and/or production-scale lots for evaluation or validation.
Can you handle shipping to different sites, including internationally?
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.
What is the lead time for obtaining a custom enzyme?
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.
What if I am unsure about which enzyme to use/would best suit my needs?
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.
How can I get a sample of an enzyme?
Start the conversation
Contact our business development experts and get started on the right track with your molecular diagnostic project.
Takara Bio USA, Inc.
United States/Canada: +1.800.662.2566 • Asia Pacific: +1.650.919.7300 • Europe: +33.(0)1.3904.6880 • Japan: +81.(0)77.565.6999
FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. © 2021 Takara Bio Inc. All Rights Reserved. All trademarks are the property of Takara Bio Inc. or its affiliate(s) in the U.S. and/or other countries or their respective owners. Certain trademarks may not be registered in all jurisdictions. Additional product, intellectual property, and restricted use information is available at takarabio.com.