Why Use Custom Services?
We Fit Our Product to Your Process.
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
Cell and Gene Therapy Custom Services
Our 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.
Our 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.
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
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.
Watch Our Custom CGT Webinar!
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.
Streamlining Transition to Animal-Free and GMP
- Why consider animal-free or GMP
- How to choose a raw materials supplier
- Support for your translational research
- Data comparisons between RUO, AF, and GMP
- Customization
- Preclinical to clinical manufacturing
This new eBook provides an overview of several biological and manufacturing challenges facing the development and production of T cell therapies. It follows with examples of how Bio-Techne products and services can address these challenges at each stage of the process.
Serum-Free and Animal-Free Cell Culture
Increase the consistency of your cell cultures as you approach translational studies for regenerative medicine and cell therapy programs. Adopting these media will
- Reduce variability in media composition
- Simplify compliance with regulatory guidelines
- Simplify comparability testing for raw material changes
Why Use Bio-Techne?
Our mission at Bio-Techne is to deliver innovative solutions that enable cell and gene therapies to reach more patients - which is why we offer a vast array of customisable products and services. Here are just a few reasons why you should consider us for your custom Cell and Gene Therapy needs:
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.
Luminex® is a Registered Trademark of Luminex Corporation.