OriGen Biomedical is a global leader in cell culture and cryopreservation products. We strive to have excellent customer service and consistently provide high-quality products. Our industry-preferred cryopreservation bags and unsurpassed quality cell culture bags have been the Gold Standard for years. Institutional processes, protocols, and operational needs can differ substantially from one organization to the next. To alleviate this, OriGen prioritizes the capability to adapt products to better fit your organization’s needs, not force you to adapt to match existing OriGen Biomedical® products. This is done through Custom Product Development.

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

When is custom product development recommended?

  • Productivity Improvements in the Laboratory

    We 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 OriGen may focus on where your laboratory is losing time in processing.

  • Protect Cells and Reduce Cell Loss

    OriGen can help your organization find ways that may save cells through more efficient processing. Together, we can try to figure out where cells may be lost in a process and how to decrease cell loss.

  • New Protocol

    OriGen can assist in the discovery of which products may be necessary for new protocols. Together, OriGen and your organization can focus on starting off a new process on the right foot.

  • Future-Focused Product Development and Clinical Trials

    OriGen can help determine which products may be necessary for new product development and clinical trials. We can recommend what you 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 more affordable than a stock OriGen Biomedical product. This is a result of manufacturing changes, tooling, and regulatory costs. If your organization is hoping to reduce the cost per item, this is not the best approach to doing that. A reduction in cost through productivity improvement and reduced cell loss is 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, custom product development 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

    Custom product development is not a short process. For projects without additional regulatory or tooling requirements, it typically takes 17 to 24 weeks. 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 custom development products have a minimum order quantity. The minimum order quantity and any development costs will be specified in the proposal prepared by OriGen.

Existing Products May Be Suggested

Often, an existing OriGen Biomedical 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. If suitable, OriGen may recommend a 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 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 manufacturer.

Custom Product Development Phases

1. Client Concept

An unmet need or pain point in your organization’s cell therapy and/or cryopreservation process is discovered and brought to OriGen.

2. Design Inputs

We 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 the decision to proceed with the project. Please note that due to the nature of custom development requests, OriGen may not be able to proceed with all projects.

4. Proposal

If the project fits within our 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 you with sample products for a customer-approved proposal. After reviewing the proposal and the samples, we 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 then manufacture and send the product. You can typically 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?

Contact Us Today!