Custom Services for Cell & Gene Therapies

Your Trusted Supplier From Discovery to the Clinic

We are in the journey with you to create revolutionary cell and gene therapies. Leverage the scientific expertise of our scientists to streamline your program to develop, scale up, and manufacture your cell or gene therapy. We will work with you to produce exactly what you need.

All of our custom products and contract services are governed by rigorous quality assurance measures, so you can be confident in the accuracy of the data and the performance of our custom products. Importantly, our manufacturing facilities ensure that, following the success of your initial research, we can provide large-scale masses of critical, specialized reagents to assure your continued success. Work performed within our FDA-regulated facility means that you can move seamlessly into regulatory agency submissions with our regulatory affairs team as a partner.

Our policies conform with the requirements of the Code of Federal Regulations (21 CFR 820); Quality System Regulations for Medical Devices, ISO 13485:2003 Standard and ISO 9001:2008 Standard, the In Vitro Diagnostic Directive 98/79/EC and the Canadian Medical Device Regulations.

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Custom services for cell and gene therapy

Custom Services

GMP Proteins

High-quality raw material and ancillary components for ex vivo cell manufacturing, including GMP cytokines and growth factors.

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GMP Antibodies

Manufactured recombinantly to ensure consistent performance and secure supply.

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GMP Cell Processing and Engineering Services

Genome engineering, activation, fill & finish for Phase I and II clinical trials.

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GMP ProDots™ Proteins

Pre-aliquoted and instantly dissolvable for closed-processing cytokine addition.

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Custom Cell Culture Media Manufacturing and Services

GMP media production, optimization of formulations, specialty media testing.

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Custom Chemistry Services

Custom synthesis, chemical sourcing, chemical analysis, and custom compound libraries.

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“No cell therapy is beyond your reach with our custom services for cell and gene therapies. At the heart of Bio-Techne is a desire to innovate and challenge the status quo while providing the safest raw material possible to cell therapy manufacturers. We understand the unique workflow and changing landscape of the cell therapy field and promise to partner with you at the cutting edge of this research. Through our custom services expertise, we will be with you on your journey to the patient, every step of the way.”

 

Sean Kevlahan, PhD

Senior Director of Cell and Gene Therapy

Bio-Techne

Sean Kevlahan, Director of Cell and Gene Therapy