Partnering with you to meet your regulatory requirements
As the demand for biopharmaceuticals and the promise of cellular therapies grow, so does the need for high quality growth factors and cytokines used for cell culture. Our experienced Quality and Manufacturing teams will partner with you to ensure we meet all of the requirements necessary to instill confidence as your reagent supplier.
Manufacturing for quality and consistency
Because proteins are produced in a biological system, 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 specifically to meet the stringent requirements necessary for their use as cell therapy reagents or as ancillary proteins used in manufacturing.
Smooth Transition from R&D to GMP
Often our GMP proteins originate from the same clone, sequence, and expression system as our traditional research grade materials. This makes the switch to GMP as seamless as possible.
Certification and Regulatory Guidelines Followed
- Manufactured in our ISO 9001:2015, ISO 13485:2016-certified facility in Minneapolis, MN
- WHO TRS, No. 822, 1992 Annex 1, Good Manufacturing Practices for Biological Products
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
- Batch-to-batch consistency records
- Materials traceability
- Employee training documentation
- Equipment maintenance and monitoring records
- and more
Quality Control Testing
Our state-of-the-art facilities have mass spectrometry, HPLC, SDS-PAGE, SEC, and DLS/SLS. We also test for endotoxin levels, the presence of host cell content and adventitious agents, and more depending on your needs.
Custom Development Manufacturing
We can make your protein of interest from scratch or manufacture our traditional proteins to GMP standards. See more about our custom protein capabilities.
We have a dedicated animal-free laboratory to ensure that proteins are never exposed to potential contamination by animal components or byproducts. Production and purification procedures use equipment and media that are confirmed animal-free.
Frequently Asked Questions
What is different between R&D Systems traditional proteins and GMP versions?
Often the sequence, the expression system, and the basic manufacturing SOP for traditional and GMP proteins are the same. This makes the transition from using research use proteins to GMP as seamless as possible.
GMP proteins also come with extensive documentation for every level of the manufacturing process including:
- A full QA review of all batch and bottling records is done before any material is shipped
- Individual specification sheets with all testing results. These are reviewed by both our QC and QA departments.
- N-terminal sequencing of the first 10 amino acids
- Viral testing of the master cell bank upon request
- Mycoplasma testing of bulk lots
- Additional bioactivity and bioburden testing after each bottling
- Lot-specific C of A that includes all testing results
- On-site audits of our facilities, records, and quality management systems available on request
- More depending on your requirements
- Contact us for more details
Are your GMP proteins animal-free?
If possible, R&D Systems GMP proteins are made in an entirely animal-free process. However, there are some proteins that require production in eukaryotic systems to maintain activity. This may be due to protein folding or post-translational modifications that can only be accomplished by making the protein in a eukaryotic cell line. In some instances these proteins can be expressed successfully in animal-free certified Sf9 insect cell line (Animal component-free; ACFP). In all cases, it is clearly stated on the website whether a specific protein is produced in an animal-free process.
What is the difference between GMP, Animal-free, and ACFP (Animal Component-free Process)
The 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.
Our 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. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free. Some animal-free proteins are also GMP.
ACFP (Animal Component-free Process)
ACFP recombinant proteins are expressed in an animal-free certified Sf9 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 our dedicated animal-free laboratories. Some ACFP proteins are also GMP.
Are these proteins pharmaceutical grade, or can they be used directly as a therapeutic?
No. Our GMP proteins can only be used as ancillary reagents for cell culture or other processes involved in the manufacturing process.