GMP Grade Proteins for Cell Therapy and Clinical Applications

2023-12-04

Recombinant proteins, particularly GMP cytokines, play a crucial role in the clinical manufacturing of biotherapeutics, necessitating a robust supply chain and scalable capabilities. Our GMP-grade recombinant proteins, manufactured in E. coli with animal-free components, cater to diverse applications such as several types of cell culture and modification. As the demand for Autologous and Allogeneic cell therapy rises, our products ensure high-quality raw materials for maximum patient safety, addressing key considerations of stability, safety, potency, and purity throughout the manufacturing process.

GMP Quality Statement
Croyez GMP® recombinant proteins are manufactured in ISO 13485:2016 and GMP-certified facility.

The processes include:

	*Animal-free reagent and laboratory*
	*Manufactured and tested under GMP guidelines*
	*Testing and traceability of raw material*
	*Records of the maintenance and equipment calibration*

	*Personnel training records*
	*Batch-to-batch consistency*
	*Documentation of QA control and process changes*
	*Stability monitors of product shelf-life*

To demonstrate lot-to-lot consistency of GMP IL-18,
the activity of three separate lots was examined and
plotted on the same graph.

To demonstrate lot-to-lot consistency of GMP IL-2,
the activity of three separate lots was examined and
plotted on the same graph.

To demonstrate lot-to-lot consistency of GMP IL-15,
the activity of three separate lots was examined and
plotted on the same graph.

Regulatory Certifications and Guidelines at Croyez GMP Manufacturing Facility

Facilities certified under ISO 13485:2016, featuring dedicated controlled-access animal-free laboratories, guarantee that products are shielded from any potential contamination by animal components or byproducts throughout the production process.
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
Sterility testing according to USP <71>.
Mycoplasma testing according to EP 2.6.7.
Bacterial endotoxin test according to USP<85>.

**Quality Control Testing for GMP Quality Management Systems**
Identity and purity	SDS-PAGE with western blotting
Concentration	UV spectroscopy
Biological activity	Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards
Safety	Endotoxin testing: kinetic chromogenic LAL assay Sterility testing: direct inoculation method Mycoplasma testing: NAT-based method (PCR) Host cell protein/ DNA content testing
Documentation	Certificate of Analysis Safety Data Sheet (SDS)

**Suggested GMP Proteins by Cell Type**
T Cell	DC	CIK	DC-CIK	NK Cell	Neuron	iPSC/ PSC
IL-1 beta IL-2 IL-4 IL-7 IL-15 IL-18 IL-21 TGF beta 1 4-1BBL IFN gamma	IL-1 beta IL-4 IL-6 IL-10 TNF alpha IFN gamma GM-CSF	IL-1 beta IL-2 IL-15 IFN gamma	IL-1 beta	IL-2 IL-15 IL-18 IL-21 TGF beta 1	FGF Noggin EGF	IL-3 IL-6 FGF-2 Activin A TGF beta 1 Noggin Flt-3L EGF SCF TPO

**Featured** **GMP Proteins**
Product	Activity (ED50)	Purity
Croyez GMP ® IL-18 (Interleukin-18), Human	<6 ng/mL	>98%
Croyez GMP ® IL-2 (Interleukin-2), Human	<46 ng/mL	>98%
Croyez GMP ® IL-15 (Interleukin-15), Human	0.5-3 ng/mL	>98%
Croyez GMP ® IFN gamma (Interferon gamma), Human	<1 ng/mL	>98%
Croyez GMP ® IL-1 beta (Interleukin-1 beta), Human	<2.0 ng/mL	>98%

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GMP Grade Proteins for Cell Therapy and Clinical Applications