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OEM customer FAQs
The most relevant questions from resellers
Early in assay development, accessing reliable components is the most critical step. This ensures the successful creation of a high-quality product. Takara Bio enzymes, buffers, antibodies, and mixes are proven to confer superior performance in the most challenging diagnostic applications developed by the market's main players. Through these questions, you will learn how partnering with Takara Bio can make your project possible.
What products can be custom manufactured?
We can custom manufacture from a large selection of DNA polymerases and enzymes that support a wide range of applications, including PCR, RT-PCR, cDNA synthesis, NGS library prep and quantitation, cloning, and gene expression.
What is the lead time for obtaining a custom enzyme?
Although our goal is to reduce the time to market, the lead time will depend largely on your criteria or requirements. Our expert advice in custom enzyme technology will help you identify the ideal custom enzyme solution to meet your specifications—from formulations, configurations, and concentrations that need to be scaled up (in any format), to labeling and packaging requirements, custom quality control testing, and documentation. Once these criteria are defined, a lead time can be provided.
Can you provide multiple lots of the custom enzyme for testing?
Depending on your specific requirements, we can provide multiple small-scale and/or production-scale lots for testing from the same bulk lot, or in the case of DNA polymerases, from different fermentations.
What quality system does TBUSA fall under?
Takara Bio USA, Inc.'s 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 you provide custom certificates of analysis?
Yes. We will work with you to finalize the quality control test and requirements, and we will generate a customized certificate of analysis that reflects your unique catalog numbers, lot numbers, and the pass/fail criteria that you require.
Packaging and shipping
Can you package a custom enzyme under my brand?
Yes. Takara Bio's trusted manufacturing capabilities are exemplified by our ability to provide custom turnkey labeling and packaging solutions to meet our customers' needs. We will work with you to define your 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 if my enzyme of choice is part of a kit? Can I order a custom enzyme only?
Yes. We can custom manufacture an enzyme for whatever your assay or platform requires, including providing it as a standalone product. We start by asking some basic questions about the format you require, including the configuration, formulation, concentration, volume, and packaging requirements. We also confirm the volume to be dispensed and whether you prefer to have the enzyme shipped in a single tube or aliquoted into smaller tubes or plates.
Custom enzyme formulation
What level of customer support can Takara Bio provide OEM partners?
Our dedicated support specialists can assist your entire development workflow and guarantee successful integration of our custom enzyme into your product portfolio. Technical information related to your custom enzyme such as a user manual, SDS, and certificate of analysis are made available, as well as additional quality documentation you request.
When is the best time to contact Takara Bio about a potential custom OEM partnership?
Contact us at the earliest stage possible. Starting the partnership as soon as possible can save on time and possible redevelopment costs if you have been unsuccessful in developing your own formulation. We can work with you as little or as much as required. We have a team of R&D scientists and manufacturing, QC, and Operations specialists ready to assist. As a partner, Takara Bio is able to share in your experience, growth, and success.
How do I get started with a customized product?
The easiest way to get started is to complete the request form on the left. An OEM business development partner will respond shortly. Our team of dedicated scientists is ready to talk to you about your custom enzyme requirements. Let us partner with you on the journey to turning your innovative ideas into tailored solutions for your customers.
What types of customizations are possible?
Customization options include private labeling, custom formulations, specialized quality control testing and/or documentation, custom vialing/dispensing, 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 standard catalog product?
Yes. We can supply higher concentrations of our catalog enzyme products. Although it varies by enzyme, we can manufacture most enzymes at concentrations up to 20 units/µl. Many of our enzymes can also be formulated with or without glycerol—for example, high concentration, glycerol-free Takara Taq and Takara Ex Taq hot-start-version DNA polymerases. Glycerol-free enzymes allow for greater flexibility in assay setup and are great for dry-down applications and automation workflows.
What if I am unsure about which enzyme to use?
Our subject matter experts can provide technical insight on experimental design and optimization, which will save you time and development costs. Our team of expert scientists 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 troubleshoot potentially suboptimal reaction conditions and recommend an optimal enzyme/buffer system that fits your precise specificity, sensitivity, and workflow requirements.
What if I require a formulation of an enzyme not listed on your website?
Takara Bio is very experienced in designing products created specifically for your research needs. In such a situation, we will switch from being your supplier to your partner in developing an enzyme that is compatible with your assay design and platform. We will create a dedicated project team consisting of project management, R&D, Operations, and QC, as well as your R&D team. First, we will work with your R&D team to develop the appropriate method. After transferring the method to manufacturing, we will work on scale-up and validation of the method. We work closely with you to understand your product requirements so we can develop a method that meets your needs. We provide samples for you to test and upon approval, we transfer the method from R&D to operations to manufacture a verification batch. Upon approval of a verification batch, we will transfer the method to the production scale batch and will provide a sample to the customer for testing. The end result will be a custom enzyme that meets the customer's research objectives, saving you time and development costs.
Can you perform specialized quality control and/or functional testing on 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.
How can I get a sample of an enzyme?
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 with you to optimize the reaction conditions. It is important to note that there are certain catalog enzyme formulations that contain additives/components that are not immediately amenable to dry down without customization, optimization, and validation in the dry-down format. In these cases, we will work closely with you to optimize the formulation to ensure it meets your performance and quality requirements.
Contact the OEM team
Do you need more information on how Takara Bio could supply the raw materials and final goods for your products?
Would you like to discuss a research collaboration agreement for Takara Bio to develop all or part of your assay?
Use the form on this page to connect with our OEM team. If you are on a mobile device, click on the menu icon () on the top left of this page, then scroll down to access the form.
You may also initiate your confidential discussion with the OEM team by sending email to email@example.com.
Takara Bio USA, Inc.
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