Ancillary Material Grade Small Molecules

The Tocris range of Ancillary Material Grade Small Molecules are intended to be utilized as ancillary reagents in the manufacture of cell therapies, for example in regenerative medicine or immune cell therapy. Specifically, they are to be used in the manipulation and culture of cells but are not intended to be present in the final cell therapy product. When developing human cell therapies, patient safety is a major consideration, so there is a need for ancillary reagents (or raw materials) manufactured with a higher level of control compared with standard research reagents used in preclinical studies. This extra level of control is provided by our Ancillary Materials Grade product range.

What Does Ancillary Material Grade Mean?

Tocris' Ancillary Material Grade products are manufactured using a greater number of quality controls and quality assurance measures than Tocris standard catalog products. This ensures that the products are as suitable as possible for the onward manufacture of cell therapies. Our Ancillary Material Grade product range offers an economical and time efficient solution to provide ancillary reagents/raw materials suitable for cell-based therapies transitioning to the clinic, whilst retaining some of the key benefits of cGMP including:

• Animal-free production (Transmissible Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE) certification);
• Segregated manufacturing area to reduce cross-contamination risk;
• Enhanced Quality Control testing including bioburden and endotoxin of final products;
• Raw material traceability.

Ancillary Material Grade Quality Attributes

Figure 1: A comparison of standard catalog (RUO) with Ancillary Material Grade products. Each block represents a stage in the manufacturing process, control measure or guidelines followed to assure the quality of the final product; the size of the bar represents the relative time expended.

For more information see GMP and Ancillary Materials Grade Small Molecules.

Regenerative Medicine

Regenerative medicine is the repair or replacement of damaged or diseased tissue to restore normal tissue function. The reprogramming of a patient's somatic cells to induced pluripotent stem cells (iPSCs) and their subsequent differentiation into specific cell types allows for implantation of autologous cells for tissue repair. Alternatively, human iPSC lines derived from peripheral blood cells of an HLA (human leukocyte antigen)-matched healthy volunteer may be obtained from a cell bank and used for allogeneic transplantation. Cord blood-derived embryonic stem (ES) cells may also be used for this purpose. The directed differentiation of cells for regenerative medicine may be achieved by using reagents, such as small molecules, growth factors and cardiac repair, type 1 diabetes and neurodegenerative disorders, such as Parkinson's and Alzheimer's diseases. Our Ancillary Material Grade small molecules are highly suitable for the manufacture of this type of cell therapy for regenerative medicine, and have been developed to assist in transitioning cell therapies from preclinical research to the clinic.

Immune Cell Therapy

Immune cell therapy has recently emerged as a form of immunotherapy and involves collecting a patient's immune cells, manipulating and expanding them ex vivo, then transfusing them back into the patient; this is also known as adoptive cell transfer (ACT). Chimeric Antigen Receptor modified T cell therapy, or CAR-T, is a form of immune cell therapy that has received regulatory approval for the treatment of hematological malignancies in patients. It involves the engineering of donor-derived T cells to express multivalent CARs on the cell surface, which recognize tumor-associated antigens. The introduction of the CAR genes into the patients' cells can be achieved by viral transfer or CRISPR/Cas9 gene editing. Small molecule viral transduction enhancers or CRISPR Reagents may be used to improve the efficiency of the genetic modification process.

The introduction of chimeric antigen receptors into natural killer (NK) cells (CAR-NK) is also being investigated as an approach for the treatment of hematological and solid tumors, as well as HIV immunotherapy. NK cells can be derived from multiple sources, including induced pluripotent stem cells (iPSCs), enabling allogeneic NK cell transplantation, which rarely induces graft versus host disease (GvHD).

How Can We Help With Your Cell Therapy Project?

Are you developing stem cell or gene therapies? We'd love to hear how small molecules can help you. Enquire about our AM-grade production queue.

Literature for Ancillary Material Grade Small Molecules

Tocris offers the following scientific literature for Ancillary Material Grade Small Molecules to showcase our products. We invite you to request* your copy today!

*Please note that Tocris will only send literature to established scientific business / institute addresses.

Stem Cell Research Product Guide

This product guide provides a background to the use of small molecules in stem cell research and lists over 200 products for use in:

• Self-renewal and Maintenance
• Differentiation
• Reprogramming
• Organoid Generation
• GMP and Ancillary Material Grade Products

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Stem Cells Scientific Review

Written by Kirsty E. Clarke, Victoria B. Christie, Andy Whiting and Stefan A. Przyborski, this review provides an overview of the use of small molecules in the control of stem cell growth and differentiation. Key signaling pathways are highlighted, and the regulation of ES cell self-renewal and somatic cell reprogramming is discussed. Compounds available from Tocris are listed.

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Stem Cell Workflow Poster

Stem cells have potential as a source of cells and tissues for research and treatment of disease. This poster summarizes some key protocols demonstrating the use of small molecules across the stem cell workflow, from reprogramming, through self-renewal, storage and differentiation to verification. Advantages of using small molecules are also highlighted.

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Stem Cells Poster

Written by Rebecca Quelch and Stefan Przyborski from Durham University (UK), this poster describes the isolation of pluripotent stem cells, their maintenance in culture, differentiation, and the generation and potential uses of organoids.

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