OriGen Biomedical is a leading producer of cryopreservation and cell culture products. Our focus is to produce a range of products to support the treatment of cancer, genetic conditions, and other life-threatening diseases. OriGen Biomedical® products are designed with the patient and user in mind, and we strive to maintain excellent customer service to ensure that patient care is the priority.

OriGen Biomedical is a growing, privately-held medical device manufacturer founded in 1997 and headquartered in Austin, Texas. Quality is the foundation of all product designs at OriGen, and each product is produced with the intention that it will improve patient health. OriGen is certified annually to ISO 13485 standards and regularly inspected by the FDA, MDSAP, ISO certification organizations, and our customers.

Our distribution center serves to reduce the time to patient by providing stock products for quicker turnaround times out of the Netherlands.

Regulatory and Accreditation information can be found here.

READ ABOUT THE HISTORY OF ORIGEN

Our Vision

To be the supplier of choice for single-use disposables within cell and gene therapy and to support transformational therapies across the world.

User-Inspired Design Commitment

We strive to find product solutions to make your operations more intuitive, safer, and more efficient. OriGen’s engineers will work with you to develop products that fit your lab practices, not make you change your practices to fit the products. Contact OriGen to find out additional information on this process.

Quality Commitment

Product quality is the foundation of all product designs at OriGen, and each product is produced with the intention that it will improve patient health. OriGen is certified annually to ISO13485 standards and regularly inspected by the FDA, ISO-certification organizations, and our customers.

Customer Commitment

We offer superior products and real customer service. We listen to our customers and work with them to develop products that meet their needs. OriGen is not just another supplier; we are a partner committed to providing you with solutions tailored to your organization. As an OriGen customer, you can be sure the same attention to detail has gone into every product with the OriGen label.

Notable OriGen Milestones

2022

OriGen Celebrates 25 Years in Business

OriGen looks back and celebrates the people, partnerships, and places that helped us become the company we are today. Read more »

2022

OriGen Biomedical Announces Closure of St. Elmo Manufacturing Facility

The St. Elmo Manufacturing Facility has ceased all production activities and shut down. The closure of the facility will affect no customers or employees. Read more »

2022

TissueVault™ Bag USA Class 1

The OriGen Biomedical® TissueVault Freezing Bags are intended to freeze cells and tissues. Read more »

2022

OriGen Receives CE Mark and Globally Launches CryoStore FLEX Freezing Bag

OriGen has been granted CE mark approval for the CryoStore FLEX Freezing Bag product line, indicating its compliance with specific requirements of relevant EU Medical Device Directives. Read more »

2021

CE Certification for St. Elmo Manufacturing Site Recieved

OriGen Biomedical is pleased to announce that we have received European CE certification for our St. Elmo Manufacturing Site, located at 2301 East St. Elmo Rd, Bldg One, Suite 110, Austin, TX 78744, USA.  Read more »

2020

Expanded into St. Elmo Facility: 1 Cleanroom

2019

Granted MDD EU Expanded Access until 2024

2019

CryoStore Multi-Chamber Bag 510K Received

The United States Food and Drug Administration (FDA) cleared the CryoStore Multi-Chamber Freezing Bag through the 510(k) process for the indication of freezing blood components. Read more »

2017

Opened Direct EU Distribution Channel in the Netherlands

2012

Expanded Burleson Facility

Added two additional clean rooms; one for sterile fill and one for product manufacture. Read more »

2010

Evolve™ Cell Culture Bag CC USA Class 1

The Evolve Cell Culture Bag is intended for use in cell culture. Read more »

2010

Moved to Burleson Facility: 1 Cleanroom, 1 Sterile Fill Suite

OriGen moves to its current Headquarters at 7000 Burleson Rd, Bldg D Austin, Texas  78744. Read more »

2009

CE Mark for CryoPur™ DMSO Received

OriGen Biomedical® DMSO and DMSO formulations are intended for the preservation of stem cells and blood components in a frozen state. Read more »

2007

Chinese NMMA CryoStore Clearance Received

2007

CE Mark for TissueVault™ Bag Received

The OriGen Biomedical® TissueVault Freezing Bags are intended to freeze cells and tissues. Read more »

2003

CE Mark for CryoStore Bag Received

The CryoStore bag is designed to freeze blood components. Read more »

2003

CE Mark for O-Wrap™ Bag Received

The OriGen Biomedical® O-Wrap Bag is intended to contain other freezing bags to protect them in long-term frozen storage. The O-Wrap bag is suitable for direct use in liquid nitrogen freezing applications. Read more »

2003

CE Mark for PermaLife™ Bag Received

The OriGen Biomedical® PermaLife bag is intended for use in cell culture and in protecting, storing, and freezing cells and tissues. Read more »

2003

CryoStore Bag 510K Received

The United States Food and Drug Administration (FDA) cleared the CryoStore Freezing Bag through the 510(k) process for the indication of freezing blood components. Read more »

1997

OriGen Biomedical, Inc. Founded

Richard Martin establishes OriGen in Austin, TX.
Read more »

1990

PermaLife™ Bag 510K Received

The United States Food and Drug Administration (FDA) cleared the PermaLife Cell Culture Bag through the 510(k) process for the intended use in cell culture and in protecting, storing, and freezing cells and tissues.  Read more »

OriGen Biomedical® is a registered trademark of OriGen Biomedical, Inc.