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Support For Your Move Toward Clinical Trials

As you consider initiating clinical trials for your cell therapy, there are many aspects of your preclinical research program to transform. Part of this exciting transition is building a robust manufacturing process that will require more extensive qualification of your raw materials.

We understand that need, and you can rely on us to provide appropriate grades of key materials – with flexibility and customization to fit your process. Our mission is to enable your therapy to reach more patients.

In the following sections, learn about how Bio-Techne’s offerings make your transition to GMP (Good Manufacturing Practice) as seamless as possible.

Why Should You Consider Animal-Free or GMP Raw Materials?

As your program moves farther along the transition from research to clinical manufacturing, it is increasingly important to document that your raw materials are compatible with manufacturing a therapeutic.

It is critical to utilize reagents that have been extensively tested and to document that the supplier’s manufacturing facility, processes, and operators are fully qualified. This is to ensure reagent integrity, batch-to-batch consistency, and traceability from starting material to final product. Thorough documentation is critical for demonstrating to regulatory agencies that raw material production meets all relevant guidelines. The additional scrutiny required to manufacture them comes at a cost but provides safeguards for patient safety as well as for your process.

Why Should You Consider Animal-Free or GMP Raw Materials Icons

Higher Grade Reagents

  • More extensive QC testing
  • Increased manufacturing control
  • More complete documentation

Benefits for Your Process

  • Improved process consistency
  • Reduced risk of batch failure
  • Regulatory compliance
  • Time and money savings

Benefits for the Patient

  • Improved safety
  • Increased availability of therapy

Case studies for transition to GMP cytokines

Case Studies

Meeting the GMP Cytokine Need for Cell Therapy Manufacturing

A cell therapy customer partnered with us for their transition to GMP cytokines and to reduce cytokine waste in a closed cell culture system.

Scaling GMP Protein Production

A customer requested the conversion of an existing RUO protein to GMP-grade as well as delivery of the GMP protein at the required scale.

What’s Important For Choosing a Raw Materials Supplier?

The relationship between a raw materials supplier and customer needs to be a partnership. It is important to evaluate potential suppliers based on how well they can support your process. Your transition from RUO to GMP can be seamless with proper communication, planning, and support from an experienced supplier. Incorporating GMP reagents into your process does not have to be a big jump.

Cytokines and Growth Factors

You can rest assured that incorporating R&D Systems™ GMP proteins into your process will not require you to perform extensive comparability testing. Our Animal-Free RUO and GMP grade proteins exhibit equivalent bioactivity and should perform the same in your process. We manufacture both grades of the corresponding proteins using the same methods and utilize the same vialing process.

Learn About Our GMP Manufacturing Facility

This consistency extends to our immunoassay platforms which are used to determine cytokine concentrations in cell culture media. Our Quantikine™ ELISAs and Simple Plex™ automated ELISAs are matched with the corresponding proteins to ensure equivalent results when moving from one grade to another.

R&D Systems GMP cytokines and growth factors

GMP Small Molecules

Transition your stem cell or regenerative medicine therapy to GMP with the right grade of small molecules at the right time. We offer RUO and GMP grades as well as an intermediate tier of small molecules (Ancillary Material Grade).

We manufacture GMP small molecules to the relevant sections of ICH Q7 guidelines to ensure consistency, traceability from start to finish, and animal-free production.

Browse GMP Small Molecules

Ancillary Material Grade small molecules provide increased manufacturing control compared to research grade.

Small Molecules Bottle

Gene Engineering Services

Sidestep the hurdles of gene engineering with lentivirus by using a non-viral method. TcBuster™ is a next-generation non-viral genetic modification system with the potential to deliver therapeutic payloads to multiple cell types to address a broad range of therapeutic applications.

TcBuster can help strengthen your gene engineering process.

  • Significant time savings for developing cell therapies
  • Reduced cost of gene modification
  • Ready availability throughout your manufacturing process
  • Delivery of larger genetic cargoes for multi-gene insertions

Inquire About TcBuster for Gene Engineering

Cell Engineering With TcBuster Graphic


Antibodies are essential in cell and gene therapy manufacturing, from cell activation and isolation to phenotypic and functional characterization. We can manufacture antibodies with enhanced specifications and documentation at gram quantities for your cell therapy process.

Our team of dedicated experts will work with you to

  • Develop a GMP antibody from scratch to your exact specifications
  • Convert an antibody from RUO to GMP
  • Convert an existing antibody to a recombinant version

Request Custom Antibody Services

R&D Systems GMP antibodies

Bio-Techne GMP Quality Compliance

GMP Quality Compliance

Navigate through evolving regulatory guidelines and geographical differences with less time and effort. Our Quality Team includes more than 120 employees in quality and regulatory roles worldwide. We ensure compliance with all relevant guidelines from governing authorities. We can help you move into regulatory agency submissions without disrupting your process.

Our team oversees:

  • Personnel training programs
  • Facility maintenance and safety programs
  • Validation of equipment and equipment calibration schedules
  • Raw materials inspection, testing, and tracing
  • Supplier qualification
  • Material review board oversight of variances

What If Animal-Free Or GMP Materials Are Not Available? Customize!

Rapid process innovations can make it difficult to obtain suitable off-the-shelf raw materials. At Bio-Techne, a dedicated project manager from our Custom Team will work with you to provide the right quality of raw materials at the times you need them.

We will work with you to develop and deliver GMP raw materials and services that meet your unique process requirements. We can provide customized vialing by mass and activity, construct design, formulation, and quality control analysis. If particular GMP products are not available, we can develop them specifically for you. Our expert scientists, quality assurance team, and world-class technical support, will provide solutions exactly tailored to minimize comparability testing during later stages.

  • Convert RUO materials to GMP
  • Vialing based on activity or mass to fit your process
  • Liquid bottling
  • Custom labeling
  • Batch reservation
  • Supply and quality agreements
  • Validation of specialized QC assays (such as raw material stability)

Inquire About Custom Projects

Bio-Techne custom GMP services

Background Information

Inquire About Our GMP Capabilities