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Why Use Custom Services? We Fit Our Product to Your Process.

The benefits of using Bio-Techne Custom Services for C&GT

 

You shouldn’t have to cut corners with your process just because you’re limited by raw materials packaging. We will bottle and package bulk reagents to fit your process requirements whether it’s research grade or GMP‑grade. Our flexibility in final fill of reagents allows you to:

  • Eliminate waste, both from a cost and a sustainability standpoint
  • Minimize manual handling and measurement
  • Reduce risk throughout the manufacturing process

Custom Services for C&GT

Proteins

GMP Proteins

Solve your development and scaling problems by leveraging the expertise of Bio-Techne scientists. Develop a new protein or manufacture your current version under GMP and Animal-Free quality requirements necessary for use as ex vivo cell therapy reagents.

Antibody

GMP Antibodies

Bio-Techne offers recombinant antibody conversion and GMP services to provide a dependable supply of custom engineered monoclonal antibodies. We can manufacture your cell therapy raw materials at gram quantities.

Gene Engineering Services

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 cells for your phase I and phase II clinical trials.

GMP ProDots™ Proteins

Our proprietary formulations and packaging are optimized for cell manufacturing workflows. We can provide customized numbers of ProDots spheres per single-use bag as well as different cytokines or growth factors in the ProDots formulation.

Custom Cell Culture Media Manufacturing and Services

Let us help you expedite and standardize your media production and testing. We will leverage our large portfolio of proteins and small molecules to manufacture your optimum media formulation.

Small Molecules and Chemistry Services

Our expertise covers custom synthesis of complex organic molecules and customized compound screening libraries. We offer comprehensive QC data packages, individualized analytical techniques, and a global supply network for sourcing.

Custom Immunoassays

We offer customization of Luminex® assays, Simple Plex™ assays, and Quantikine™ ELISAs. Let us take care of your assay development and optimization, ELISA kit manufacturing, and assay conversion to automated platforms.

Flow Cytometry Reagents

Flow Cytometry Reagents

Our team has decades of custom antibody conjugation experience. We can provide small to large scale custom flow cytometry conjugates with a fast turnaround and complete validation.

Cloudz Cell Activation Kit

Cloudz™ Cell Activation Kits

We can customize our dissolvable sphere technology with our vast selection of antibodies and bioactive proteins. Use screening formats to identify optimum cell receptors or a dedicated kit produced to RUO or GMP standards.

Customization at the raw material level enables cell therapy manufacturers to be confident in the security of their supply, de-risk manufacturing processes, and improve their scalability. Register to watch our on-demand webinar to learn the importance of customized raw materials for cell and gene therapy.

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Flexibility

Our GMP-grade ancillary reagents are designed to plug into your closed system ex vivo cell manufacturing systems. 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.

Reduced Risk

We develop cell therapy manufacturing products to help you reduce the risk to your process. We follow GMP regulatory frameworks and evaluate the standard of reagent design with simplicity and safety in mind. Our goal is to protect your cell therapy product by minimizing contamination and introduced human error.

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 supply complete documentation and verification of lot-to-lot consistency for every GMP product.

Scalability

Our extensive experience in manufacturing and our stringent quality system at Bio-Techne will ensure that we can deliver the GMP reagent supply required for your scale-up. With ISO 9001 and 13485 Certifications, USP and European Guidelines in place, you can have confidence in the supply and quality of our raw materials for immune and stem cell therapy manufacturing.

Senior Director of Cell and Gene Therapy

“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, Ph.D.

Senior Director of Cell and Gene Therapy

Bio-Techne

Inquire About Custom Cell & Gene Therapy Services