Drug development is full of unknowns. Don't let your reagents be one of them.

Quality Control & Assurance

At KACTUS, we focus on quality at every step of the process, from protein engineering to manufacturing, so you can be confident in the products you receive.

KACTUS recombinant proteins are designed and manufactured in-house, giving a high level of control over every step from protein engineering to product validation. We test each product for bioactivity throughout the development process to ensure function in multiple in vitro settings. Each batch undergoes strict quality control testing including purity, activity, and endotoxin. Our high level of control results in superior batch to batch consistency. Moreover, the majority of our products are expressed using mammalian cell lines, allowing for post-translational modification, native protein conformation, and low endotoxin levels. 

Vertical integration of protein engineering & manufacturing

Mammalian cell line expression systems

Comprehensive quality control testing

ISO13485 Accreditation

KACTUS quality management systems are ISO13485:2016 certified. Combined with our digital MES system, raw material tracking, and large-scale facilities, KACTUS products are suitable for long-term scalable supply.

Quality Control

Quality control is a critical aspect of recombinant protein production that ensures the purity, potency, and consistency of the final product. Our quality control systems are designed to monitor and assess the quality of the production process and final product.

Process Validation

We monitor the entire production process to ensure expression conditions are optimal for that specific protein. This includes monitoring the growth of the host cells, expression of the target gene, and purification of the recombinant protein. The expression process is optimized to minimize the presence of contaminants that can affect the purity or activity of the final product.

Analytical Testing

PURITY The purity of each recombinant protein is ensured using HPLC and by quantifying the level of impurities, such as host cell proteins, endotoxin, and host cell DNA in the final product. 

ACTIVITY The potency of our recombinant proteins is analyzed by measuring its in vitro activity, such as its ability to bind to its target molecule via ELISA or SPR assay. 

CONSISTENCY Our products are tested for batch-to-batch consistency to ensure stable bioactivity across lots. Additionally, we assess stability of our products by measuring degradation over time and resistance to environmental stress factors, such as temperature and pH changes.

Analytical Equipment

CytoFlex SRT Flow Sorter

Biacore T200

6545XT Q-TOF Mass Spectrometer

Microplate Reader

Capillary Electrophoresis

1260 High Performance Liquid Chromatography

Batch to batch cosistency

Figure 1. Immobilized Human DLL3, His Tag at 0.1μg/mL (100μL/well) on the plate. Dose response curve for Anti-DLL3 Antibody, hFc Tag with an EC50 of 5.0, 4.5, and 5.0ng/mL, respectively, as determined by ELISA.

Figure 2. Immobilized Human Siglec-10, His Tag at 0.5μg/mL (100μL/well). Dose response curve for Anti-Siglec-10 Ab., hFc Tag with an EC50 of 7.3, 7.7, and 7.4ng/mL, respectively, asdetermined by ELISA.

Figure 3. Immobilized Human CD4 at 0.5μg/mL (100μL/well) on the plate. Dose response curve for Anti-CD4 Antibody, hFc Tag with an EC50 of 10.2, 10.6, 10.6ng/mL, respectively, as determined by ELISA.

Quality Assurance

Our quality management system monitors the entire production process to ensure each batch is manufactured under the same optimal conditions for that protein. This includes monitoring the growth of the host cells, expression of the target gene, and purification of the recombinant protein. Moreover, the protein expression process is optimized during development to minimize the presence of contaminants that can affect the purity or activity of the final product.