Transition To GMP For Cell Therapy Manufacturing
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.
Introduction to Animal Free Proteins
What Are Animal-Free RUO Proteins?
Animal-free RUO proteins are made in an E. coli expression system and are purified and manufactured in a dedicated animal-free area using equipment and media certified as animal-free. This manufacturing process ensures that these proteins are never exposed to potential contamination by animal components or byproducts, which is particularly important for researchers concerned with experimental variables caused by the presence of trace animal components or mammalian pathogens.
When Should Researchers Use Animal-Free RUO Proteins?
Animal-Free RUO proteins are highly recommended for:
Researchers who need defined, reproducible culture conditions and are particularly concerned about experimental variables caused by the presence of trace animal components or mammalian pathogens
Researchers who are concerned about animal-derived reagents due to regulatory or ethical issues
Preclinical researchers whose work has the potential of progressing into clinical trials or clinical manufacturing
Our Animal-free RUO proteins originate from the same clone, sequence, and expression system as our Animal-free GMP-grade proteins and they are manufactured using the same methods, providing for a seamless transition from preclinical research into clinical manufacturing.