Enzymes & Reagents for GMP Manufacturing of Cell, Gene, and Other Biological Therapies

Enterokinase (light chain), highly specifically recognizes the Asp-Asp-Asp-Asp-Lys sequence and hydrolyzes the polypeptides at the C-terminus of Lys. It can convert trypsinogen to trypsin in vivo, and fusion proteins with this recognition sequence can also be cleaved. This product, enterokinase, produced by recombinant yeast secretion and expression system, is of a high purity, high bio-activity, and an excellent stability, which allows a wide range of working condition (4-45℃, pH 4.5-9.5) even keeps a part of bio-activity in the presence of various detergent and denatured agents. This product is from a large scale GMP leveled recombinant enterokinase production via Pichia pastoris expression. Applying pharmaceutical leveled adjuvant and material for production, strictly controlling host protein residues, nucleic acid residues and other impurities, we guarantee manufacture and quality control practice complying to GMP regulation, as well as all the materials traceable.

Different grades and packaging are available.

Different grades and packaging are available.

NovoStart® High-Specificity Probe qPCR SuperMix (UDG) is a premix consisting of specially processed HotStart Taq DNA polymerase, UDG, dNTPs (including dUTP), and carefully optimized reaction buffer. It is a 2× concentration premixed reagent. When conducting experiments, the preparation of PCR reaction solution is simple and convenient. HotStart Taq DNA polymerase treated with special process can effectively reduce nonspecific amplification caused by nonspecific annealing of primers or primer dimers. Combined with carefully optimized reaction buffer, it has high specificity and sensitivity.

Different grades and packaging are available.

CRISPR-Cas9 is an adaptive immune system developed by bacteria and archaea during the long-term evolution. The CRISPR-Cas9 system integrates fragments of invaded phage and plasmid DNA into CRISPR sequences and uses the corresponding CRISPR RNAs (crRNAs) to guide the cutting of homologous sequences by Cas9 protein and the system has immune memory ability. The artificially modified Cas9/sgRNA system can guide Cas9 protein to recognize and cut double-stranded DNA with sgRNA targets through sgRNA (single guide RNA), which can be used for gene knockout and precise DNA editing. The recombinant S. pyogenes Cas9 protein expressed in E. coli which is cultured in animal-free medium and the protein is purified by multi-step column chromatography. It is produced with pharmaceutical raw materials and the host-cell protein residues and nucleic acid residues are strictly controlled. Product production and quality control conform to GMP standards, ensure the production process and all raw materials traceable.

Fibronectin (rFN-CH296, NovoNectin) is involved in cell attachment, spreading, differentiation, and proliferation. It can greatly improve the infection efficiency of retroviruses on mammalian cells. VLA-4 and VLA-5 on the cell surface bind to the CS-1 site and the cell-binding domain on NovoNectin, respectively, and the retroviral vector binds to the heparin-binding domain, thus promoting the transfection efficiency of retroviruses and lentiviruses on cells. NovoNectin® can be mixed with anti-Human CD3 mAb for coating to enhance T cell amplification. Recombinant Human NovoNectin is expressed by E. coli, and is produced with raw materials of pharmaceutical applicable level. The host protein residue, nucleic acid residue and common pathogens are strictly controlled, and the production and quality management procedures of the product comply with GMP regulations to ensure the traceability of the production process and all raw materials.

BenzoNuclease® is a recombinant endonuclease derived from Serratia marcescensa. The protein is expressed in Escherichia coli (E. coli). BenzoNuclease® has been shown to exert a broad spectrum of substrate specificity to degrade both DNA and RNA—whether single-stranded, double-stranded, linear, circular or supercoiled. No base preference is observed. As with all endonucleases, BenzoNuclease® hydrolyzes internal phosphodiester bonds present between the nucleotides. Upon complete digestion, all free nucleic acids present in solution are reduced to 5’-monophosphate-terminated oligonucleotides, which are three to five bases in length. In scientific research, BenzoNuclease® can be used as the preferred enzyme preparation for supernatant of cultured cells and viscosity removal of cell lysate, which can remove nucleic acid interference and improve the subsequent protein purification or functional research. At the same time in the vaccine industry, protein and polysaccharide pharmaceutical industry, used to remove the host residual nucleic acid, greatly reduce the vaccine and protein products of nucleic acid pollution, reduce the processing steps, improve the yield of products. This product is expressed by large-scale fermentation of E. coli, and is produced with raw materials of medicinal specifications. The host protein residue, nucleic acid residue and common pathogens are strictly controlled, and the production and quality management procedures of the product comply with GMP regulations to ensure the traceability of the production process and all raw materials.

BenzoNuclease® is a genetically engineered endonuclease from Serratia marcescens. BenzoNuclease® acts as an endonuclease that degrades both DNA and RNA—whether single stranded, double-stranded, linear, circular or supercoiled. Upon complete digestion, all free nucleic acids present in solution are reduced to 5’-monophosphateterminated oligonucleotides, which are three to five bases in length. BenzoNuclease® is an efficient enzyme for removing all forms of DNA and RNA from biological products. In processed biological products, there may be traces of BenzoNuclease® residues, and these traces of residues will have a certain impact on the application of subsequent biological products. The residual amount of BenzoNuclease® in biological products is one of the important indicators to measure the quality of biological products. This kit can detect and quantitatively analyze the BenzoNuclease® residues in recombinant viral vectors and vaccine preparations with high sensitivity and specificity. Reaction Principle

BenzoNuclease® is a recombinant endonuclease derived from Serratia marcescensa. The protein is expressed in Escherichia coli (E. coli). BenzoNuclease® has been shown to exert a broad spectrum of substrate specificity to degrade both DNA and RNA—whether single-stranded, double-stranded, linear, circular or supercoiled. No base preference is observed. As with all endonucleases, BenzoNuclease® hydrolyzes internal phosphodiester bonds present between the nucleotides. Upon complete digestion, all free nucleic acids present in solution are reduced to 5’-monophosphate-terminated oligonucleotides, which are three to five bases in length. In scientific research, BenzoNuclease® can be used as the preferred enzyme preparation for supernatant of cultured cells and viscosity removal of cell lysate, which can remove nucleic acid interference and improve the subsequent protein purification or functional research. At the same time in the vaccine industry, protein and polysaccharide pharmaceutical industry, used to remove the host residual nucleic acid, greatly reduce the vaccine and protein products of nucleic acid pollution, reduce the processing steps, improve the yield of products. This product is expressed by large-scale fermentation of E. coli, and is produced with raw materials of medicinal specifications. The host protein residue, nucleic acid residue and common pathogens are strictly controlled, and the production and quality management procedures of the product comply with GMP regulations to ensure the traceability of the production process and all raw materials. FDA DMF {{GMP-1707_application_3.png}} [[GMP-1707_application_3.png]]