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Higher Raw Material Grades To Fit Your Advancing Process

 

As you develop and scale your process, your requirements for raw materials will likely become more demanding. You may need to improve experimental consistency, or you may need to satisfy regulatory guidelines for clinical manufacturing. In addition, you may require increased quantities of raw materials and have confidence your suppliers can meet your needs.

We understand the need for adopting increasingly well-defined raw materials. Regardless of where your program is in this trajectory, you can rely on us to provide multiple grades of key materials – with flexibility and customization to fit your process.

Bioreactor for GMP Manufacturing

Why Consider Animal-Free or GMP Raw Materials?

 

Higher grades of raw materials offer advantages over research use only (RUO)-grade materials. Compared to RUO, these grades are manufactured with increased process control, are more extensively tested, and are supplied with more complete documentation. This additional scrutiny comes at a cost but provides the user with improved process consistency and regulatory compliance.

Incorporation of higher grades of materials early in your program can actually simplify your transition to the next stage. If clinical applications are your goal, it is far easier to perform equivalency testing during preclinical stages than later when material changes can be much more costly and time-consuming. These savings typically outweigh the additional cost of animal-free and GMP products.

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 whether or not they can support your process. With proper communication, planning, and support from a supplier, your process transition can be seamless. The transition from research use only (RUO) to animal-free and GMP materials does not have to be a big jump.

  • An experienced supplier will have a deep understanding of quality management systems and analytical testing methods. In addition, a supplier experienced in regulatory matters will help you navigate rapidly evolving regulatory landscapes.
  • A flexible supplier should be readily accessible for providing technical and regulatory support throughout the duration of your program.
  • It is perfectly valid to inquire about the supplier’s manufacturing processes and specifications for all available grades of raw materials. Differences in either physical or performance specifications could signal that your transition might not be straightforward.
  • A supplier should welcome audits of their production facilities and should make virtual audits available if in-person audits are not possible.
  • A supplier that provides Drug Master Files (DMF) with detailed information about their raw materials can assist regulatory authorities and ease applications for investigational new drugs (IND).

How We Support Your Translational Research

 

As you advance your research towards clinical manufacturing, you should have confidence that incorporating animal-free and GMP raw materials is efficient and does not functionally impact your process. In the following sections, learn about how Bio-Techne’s offerings make this transition as seamless as possible.

Cytokines and Growth Factors

 

Our animal-free preclinical and GMP proteins share the same biological activities as those produced using our standard processes. We manufacture both grades of the corresponding proteins using the same methods and are packaged with the same vialing process. This ensures the smoothest possible transition from one grade to the next.

This consistency extends to our immunoassay platforms which are used to determine cytokine concentrations during QC testing of 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.

Small Molecules

 

To meet the rapidly increasing needs of stem cell and regenerative medicine research, we offer RUO and GMP grades as well as an intermediate tier of small molecules. The synthesis of Ancillary Material Grade small molecules is based on established procedures for the equivalent RUO products but adhere to the ISO technical standard ISO/TS 20399 guidelines on the requirements for ancillary materials. We manufacture GMP small molecules to the relevant sections of ICH Q7.

Cloudz™ Cell Activation Kits

 

The GMP versions of our kits for immune cell activation are built with in-house, fully humanized GMP antibodies. The GMP kits meet USP 71 sterility guidelines and are packaged in larger volumes for the activation and expansion of larger batches of cells. We also offer a Cloudz Human NK Cell Expansion Kit that utilizes humanized RUO antibodies instead of mouse RUO antibodies.

ScaleReady Logo

Advance your cultures with an innovative cell expansion platform that alleviates scale-up challenges. Our partners at ScaleReady offer G-Rex well plates and closed-system bioreactors that allow the same protocols to be used from early research through commercial scale up, dramatically simplifying transition to GMP manufacturing.

Antibodies

 

Antibodies are essential in cell and gene therapy manufacturing, from cellular activation and isolation to phenotypic and functional characterization. Our team of dedicated experts will work with you to develop a GMP antibody from scratch to your exact specifications. Alternatively, convert an antibody from RUO to GMP and have confidence in a consistent and scalable supply. 

Cell Engineering

 

The TcBuster gene delivery system is the basis for our cell engineering services for everything from proof-of-concept work through process development and contract manufacturing. From the outset we will work with you to build in the flexibility needed to meet the demands of scaling to commercialization. As a contract development and manufacturing organization (CDMO), we offer in-house process development for gene modified therapies, GMP patient sample processing for Phase I and Phase II clinical trials, and GMP cell product manufacturing.

Cell Engineering With TcBuster Graphic

Quality Compliance

 

Ensuring compliance with all relevant guidelines from governing authorities is time consuming considering the evolving guidelines and geographical differences. Count on our team of over 120 quality and regulatory employees to ensure that you can move into regulatory agency submissions without disrupting your process.

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.

  • Converting 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)

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
Adherent cells in culture supported by extracellular matrix

Background Information

Inquire About Our GMP Capabilities