Solve your development and scaling problems by leveraging the expertise of Bio-Techne scientists. Develop a new protein or manufacture your current version under Good Manufacturing Practice (GMP) and Animal-Free quality requirements necessary for use as ex vivo cell therapy reagents.
Bio-Techne offers recombinant antibody conversion and GMP services to produce a dependable supply of custom engineered monoclonal antibody. Manufacture your diagnostic and therapeutic reagents at the gram quantities required.
GMP Cell Processing and Engineering Services
Partner with our experts to develop an optimized process to take your CAR or TCR therapy to the clinic. We provide CDMO services for your gene modified therapy to process your phase I and phase II clinical trials.
GMP ProDots™ Proteins
Our proprietary formulations and packaging are optimized for cell manufacturing workflows. We will meet your requirements for amount of protein per single-use bag. We can also provide different cytokines or growth factors in this formulation.
Custom Cell Culture Media Manufacturing and Services
Let us help you expedite and standardize your media production and testing. Using design-of-experiments (DOE) and our large portfolio of proteins and small molecules, we can generate media formulations to find your optimum recipe.
Custom Chemistry Services
Our expertise covers custom synthesis of complex organic molecules, global supply network for sourcing, comprehensive QC data packages and individual analytical techniques, as well as customized compound screening libraries.
What to Expect
Consistency and Reproducibility
You want to be confident your process will be reproducible, compliant, and traceable. This starts with consistency at the raw material level. We apply stringent quality standards to all our cell therapy reagents and technologies. We are proud to provide proper documentation and lot-to-lot consistency for every GMP product.
Extensive experience in manufacturing and a stringent quality system at Bio-Techne will ensure that our GMP reagent supply meets your requirements for scale-up. With ISO 9001 and 13485 Certifications, USP, and European Guidelines in place, you can be assured in the supply and quality of our raw materials for immune and stem cell therapy manufacturing.
Our GMP-grade ancillary reagents are designed to plug into existing closed system ex vivo cell manufacturing workflows. This flexibility lets you determine the best culture vessel and manufacturing combination for scaling up your specific cell therapy. No cell therapy challenge is beyond our ability to help.
We are developing cell therapy manufacturing products to help you reduce the risk to patients. By following GMP regulatory frameworks and re-thinking the standard of reagent design with simplicity and safety in mind. Keeping your cell therapy product safe from added human error and contamination.
“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