This service may result in a variation of an existing OriGen product that is more ideally suited for your organization’s processes.

OriGen Biomedical is a global leader in cell culture and cryopreservation products. OriGen Biomedical is well known for its excellent customer service and high-quality products. It is industry-preferred cryopreservation bags and unsurpassed quality cell culture bags have been the Gold Standard for years. OriGen’s customer service partners with our engineering team to adapt customer needs into thoughtfully designed products to better fit laboratories’ protocols, not force labs to change protocols to match OriGen’s products. This is done through OriGen’s Custom Product Development.

When is custom product development recommended?

  • Productivity Improvements in the Laboratory

    The consultation can assist your organization in saving time in processing cellular products. This time savings can be from streamlining processes, reducing sterile docking, and many more reductions in staffing cost. The consultation with the OriGen Business Development Team may focus on where your laboratory is losing time in processing.

  • Protect Cells and Reduce Cell Loss

    The consultation can assist your organization in finding ways that you may save cells through more efficient processing. The consultation with the OriGen Business Development Team may focus on where cells may be lost in a process and how to decrease cell loss.

  • New Protocol

    The consultation can assist your organization with discovering which products may be necessary for a new protocol. The consultation with the OriGen Business Development Team may be focused on starting off a new process on the right foot.

  • Future-Focused Product Development and Clinical Trials

    The consultation can assist your organization with discovering which products may be necessary for new product development and clinical trials. This consultation with the OriGen Business Development Team may focus on what your organization will need as your new product is scaling from Phase I to Manufacturing.

When is custom product development NOT recommended?

  • Individual Product Cost Reduction

    Products that are designed as a result of the OriGen process improvement consultation are rarely cheaper than a stock OriGen product. This is a result of manufacturing changes, tooling, and regulatory costs. If your organization is hoping to reduce the cost per bag, this is not the best approach to doing that. A reduction in cost through productivity improvement and reduced cell loss are possible, which will be more beneficial in the long term for your organization.

  • End Product is Outside of OriGen’s Area of Expertise

    OriGen manufactures disposable, single-use, sterile products made primarily for cell culture, cryopreservation, and other blood processing procedures. If the intended use of a new product is outside of OriGen’s area of expertise, the process improvement consultation may not be the best fit. Feel free to contact OriGen to discuss the project, as the project may still complement our area of expertise or we may be able to assist your organization in finding a better fit for the project.

  • Product is Needed Immediately or Within 12 Weeks

    The consultation is not a short process as it may take anywhere from 17 to 24 weeks for projects without additional regulatory or tooling requirements. The process improvement consultation is meant to provide organizations with a long-term solution to productivity challenges. It is not meant for one-time projects that are immediately needed.

Possible Outcomes of Custom Product Development

OriGen Designs and Develops New Products 

A product that meets your specific processes and protocols will be made for your organization. The product may require new tooling or regulatory approvals and will incur development expenses that will be included in the final cost. All customer-driven development products have a minimum order quantity. The minimum order quantity and any development costs will be specified in the proposal prepared by OriGen.

OriGen Existing Products May Be Suggested

Often an existing OriGen product or combination of products can be used to achieve your desired outcome. Existing products are generally more affordable and can be provided with a shorter lead time than developing a product. OriGen may recommend a current stock or non-stock product that will work well for your organization.

No Product Is Developed

OriGen performs a multi-functional evaluation of each project request to ensure the resulting product is feasible and would meet OriGen’s and your quality standards and expectations. The project evaluation may suggest that OriGen is not the best company to manufacture a product for your organization. In this case, OriGen may recommend an alternate company.

Custom Product Development Phases

1. Client Concept

You approach OriGen with an unmet need or pain point in your organization’s cell therapy and/or cryopreservation process.

2. Design Inputs

The OriGen Business Development Team will work with you to create a list of design inputs to drive the product design. Regulatory requirements will also be established which can add significant time and cost to a project.

3. Project Evaluation

OriGen will evaluate the feasibility of the project request and notify you of our decision to proceed with the project. Please note that due to the large volume of customer development requests, OriGen may not be able to proceed with all projects.

4. Proposal

If the project fits within OriGen’s capabilities, and we feel confident we can meet your needs and expectations, OriGen will provide a proposal that includes a concept drawing, pricing, and lead time.

5. Samples and Design Modifications

OriGen can provide sample products for a customer-approved proposal. After reviewing the proposal and the samples, OriGen will incorporate your feedback by making necessary design modifications.

6. Finalize Development

When the design is agreed upon by you and our development team, OriGen will finalize the product details. Please note that the design may not be changed after samples are approved. Late-stage design changes will incur a change fee.

7. Manufacture Product

OriGen will manufacture and send the product. You can expect to receive products within 17 – 24 weeks from the receipt of a Purchase Order. Please note that new tooling, regulatory submissions/approvals, and/or validations will significantly impact lead times.

Interested in Custom Product Development?

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