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Frequently asked questions

OEM Powered by Takara Bio

OEM partnerships require close collaboration, effective communication, and confidentiality over an extended period. Browse our frequently asked questions to learn how we power your project from concept to commercialization and beyond.

Find answers to your questions

Timeline and budget

What is the lead time for obtaining a custom enzyme?

The lead time will depend largely on your requirements. Our expertise in custom enzyme technology will aid in the selection of your ideal enzyme solution. Once these criteria are defined, we will provide an accurate lead time in accordance with your development timeline.

What are the costs associated with an OEM partnership for your products?

Our team will work closely with you to provide a solution that meets your budget without compromising quality or performance, ensuring the best value for your investment. Many OEM formulations are priced at or even below our enzyme list prices, given the large volume of product manufactured. There are no hidden costs, like documentation or contract fees, associated with an OEM partnership; these are included in the cost of the final product.

Are pricing tiers or options available?

We offer tiered pricing based on order volume; larger orders mean lower manufacturing costs, allowing us to provide more cost-effective options. Let us know your needs, and we’ll tailor a pricing plan to fit your budget.

Product related

What if I am unsure about which enzyme to use?

Our team of experienced scientists will consult with you on specific assay requirements related to your sample type, buffer composition, amplicon size and complexity, reaction volume, and other parameters. Based on this information, you will receive a recommendation on an enzyme/buffer system that fits your precise specificity, sensitivity, and workflow requirements.

How can I get a sample of an enzyme or product?

Our popular samples can be found on this page, but the selection is not limited to what’s displayed there. Request samples of your choice by completing the form on the sample request page. Alternatively, email oem@takarabio.com.

What products can be custom manufactured?

As an original manufacturer, we can customize almost any catalog product, whether it’s a complete kit or a specific component.

What types of product customizations are possible?

We offer a wide range of customization options to fit your unique needs. Options include but are not limited to configurations, private labeling, custom formulations, specialized quality control testing and/or documentation, preparation of cryo-ready mixes, lyophilization, and simplified packaging to accommodate automated workflows.

Can I request an enzyme at a higher concentration than what is available for the catalog product?

Yes, we can supply higher concentrations of our catalog products. Although it varies by each enzyme, most enzymes can be manufactured at concentrations up to 20 units/µl. Some enzymes can also be formulated without glycerol, which allows greater flexibility in assay setup for high-throughput, dry-down, and other applications. For a complete list of glycerol-free enzymes, see the formulation-friendly dropdown on our Request samples page.

What if I require an enzyme formulation that is not listed on your website?

A dedicated project team consisting of project management, R&D, Operations, and QC will work with you to assess the feasibility of developing an enzyme formulation that is compatible with your assay design and platform. If it is feasible, we can create a small-scale test batch to evaluate performance. After transferring the method to manufacturing, production can be scaled up and validated accordingly. The end result will be a custom enzyme that meets your research objectives.

Do you have lyophilization capabilities?

Yes. We can prepare lyophilization-ready mixes for dry down in strip tubes, plates, or cartridges/consumables and will work closely with you to optimize the reaction conditions. Please note that certain enzyme formulations contain additives/components that are not amenable to lyophilization. In such cases, the formulation will be optimized to suit the dry-down process.

Can you package a custom enzyme under my brand?

Yes. We will work with you to define your specific packaging requirements and recommend the best possible solution for your private labeling. Our professional design team will create high-quality labels with your product description and a logo image.

Can you provide multiple lots of a custom enzyme for evaluation?

Depending on your specific requirements, multiple lots from small-scale batches can be provided for testing lot-to-lot consistency. These multiple lots can be from different batches derived from the same fermentation (e.g., in the case of DNA polymerases) or from different fermentations.

How do I get started with a customized product?

You can get started easily by completing the request form on the left or emailing oem@takarabio.com. An OEM business development partner will respond shortly.

Quality assurance

What quality system does TBUSA fall under?

Our quality management system has received a certification specific to medical devices and related services under ISO 13485:2016. This ISO certification demonstrates our unwavering commitment to delivering the highest quality products. It ensures that all of our customers benefit from using products that meet rigorous industry standards. We can provide a copy of our certification upon request or it can be accessed directly from the Quality and Compliance section of our website.

Can you perform specialized quality control and/or functional testing on a 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 the custom product. If required, we will work with you to design customized quality control tests that fit your specific requirements. We will also provide expert guidance on recommended testing procedures and ensure the necessary documentation and data are available for your project.

Can you provide customized certificates of analysis (CoA)?

Yes. We will work with you to finalize the quality control tests and generate a customized certificate of analysis that reflects your unique catalog numbers, lot numbers, and quality criteria.

Support and partnership

What level of customer support can you offer to an OEM partner?

Dedicated support specialists can assist with your entire development workflow and guarantee successful integration of our enzyme into your product portfolio. We act as your personal manufacturer, providing all technical information and documentation required for your products.

When is the best time to contact you about a potential OEM partnership?

Starting the partnership at the earliest stage possible can save on time and redevelopment costs. Our R&D scientists, manufacturing experts, and QC and Operations specialists are ready to assist your product development and accelerate your time to market. As a partner, we are fully invested in your experience, growth, and success—working alongside you every step of the way.


Start a conversation with us

Begin a partnership by connecting with our OEM team. Initiate the confidential discussion by emailing oem@takarabio.com or completing the form on the upper left. If you are on a mobile device, click on the hamburger icon () on the top left of your screen, then scroll down to access the form.

We'll reach out to understand your needs and establish how we can help further your success. In the meantime, we invite you to explore our OEM resources.


Learn more about our OEM services

OEM overview

Bright ideas become brilliant solutions when you are supported by our expert OEM team.

Portfolio

Review technology highlights and customization options.

Process

Take a look inside the process of an OEM partnership with Takara Bio.

Facilities

Learn about our extensive manufacturing infrastructure and stringent quality standards.

Request samples

Compare a selection of powerful enzymes and request samples for evaluation.

FAQs

Get answers to frequently asked questions about Takara Bio's OEM and custom enzyme manufacturing services.

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Takara Bio USA, Inc. provides kits, reagents, instruments, and services that help researchers explore questions about gene discovery, regulation, and function. As a member of the Takara Bio Group, Takara Bio USA is part of a company that holds a leadership position in the global market and is committed to improving the human condition through biotechnology. Our mission is to develop high-quality innovative tools and services to accelerate discovery.

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Takara Bio USA, Inc. provides kits, reagents, instruments, and services that help researchers explore questions about gene discovery, regulation, and function. As a member of the Takara Bio Group, Takara Bio USA is part of a company that holds a leadership position in the global market and is committed to improving the human condition through biotechnology. Our mission is to develop high-quality innovative tools and services to accelerate discovery.

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  • Human ACE2 stable cell line
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  • DNA-seq
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  • cDNA synthesis kits
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