Good Manufacturing Practice Protein Services

GMP Protein Services

As proteins are produced in biological systems, changes in the manufacturing environment or processes can make them susceptible to batch-to-batch variability. Extraordinary attention to detail at all levels of the manufacturing process is necessary to ensure consistency. R&D Systems GMP proteins are designed to specifically meet the stringent requirements necessary for their use as cell therapy reagents or as ancillary proteins used in manufacturing. Develop a GMP protein from scratch or take an existing protein to GMP level.

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GMP Protein Vials

Protein Services


Dedicated controlled-access animal-free laboratories ensure that at no point in production are these products exposed to potential contamination by animal components or byproducts. Some animal-free proteins are also GMP.


Proteins are manufactured under guidelines that allow for their use as ancillary materials in cell therapy or for further manufacturing processes. They may or may not be manufactured using animal-free processes depending on the characteristics of the given protein.

Animal Component-free Process (ACFP)

ACFP recombinant proteins are expressed in an animal-free certified insect cell line using dedicated animal-free raw materials and labware. Production and purification procedures use equipment and media that are confirmed animal-free but performed outside of our dedicated animal-free laboratory. Some ACFP proteins are also GMP.

The R&D Systems GMP Advantage:

Often our GMP proteins originate from the same clone, sequence, and expression system as our traditional research grade materials. This makes the conversion to GMP as seamless as possible. We can convert an existing protein to GMP or we can completely develop a protein of interest from scratch.

  • Full QA Review
  • Individual specification sheets
  • N-terminal Sequence
  • Viral Testing
  • Mycoplasma Testing
  • Additional Bioactivity/Bioburden
  • Lot specific C of A
  • On site audits
  • Traceability
  • Batch-to-batch consistency

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