GMP-Grade Cytokine/Antibodies

Standardized GMP-grade Production Environment and Management System

A GMP-grade clean production workshop of nearly 10,000 square meters is constructed, and GMP is implemented to ensure the controllability and traceability of materials and processes. Filling in the preparation workshop is in accordance with the requirements of Class B sterile preparations and the formulations are prepared with pharmaceutical-grade excipients.

Regulations for Production and Quality Control

Good Manufacture Practice (2010)

GMP Appendix — Cell Therapy Products (Draft for Public Comment)

Chinese Pharmacopoeia

Chapters <92> and <1043>, USP

General Chapter 5.2.12, Ph. Eur. 

Quality Assurance

▪ Animal origin-free materials and pharmaceutical-grade excipient formulations

▪ Sterile, ampicillin-free, pathogens-free (HBV, HCV, HIV), mycoplasma-free

▪ Endotoxin of less than 10 EU/mg, residual host cell protein of less than 0.005%, residual exogenous DNA of less than 100 pg/mg

▪ High purity, high activity, high stability

▪ Good inter-batch consistency

▪ Packaging in pharmaceutical-grade vials

GMP-Grade BenzoNuclease®

BenzoNuclease® (Novoprotein): Excellent Quality and Low Price. The GMP-grade BenzoNuclease®, developed by Novoprotein, is animal origin-free and ampicillin-free. BenzoNuclease® efficiently degrades DNAs and RNAs of all forms, including single-/double-stranded or linear/circular/supercoiled. The product is reliable in quality, performance, and supply capacity. The Drug Master Files (DMF) filing by U.S. FDA has been completed, meeting the specifications of drug application.

"Magic gene editor"-Introduction of CRISPR/Cas9 system and selection of transfection system

Novoprotein provides GMP grade Cas9 and scientific research grade Cas9/Cas12a/Cas13a and other Cas family protein products with high-quality to support gene editing research.

Product advantages:

Pure protein system, no risk of exogenous gene introduction

Cas9 protein degradation rate is fast, which effectively reduce off-target effect.

Culture without animal source medium

Low endotoxin, no residual endonuclease, exonuclease, and RNA enzyme

Nuclear localization signals (NLS) wereadded to both ends of the protein, and the protein can enter the nucleus for genome editing.

In vitro cutting efficiency is higher than 90%

The manufacturing and quality control of GMP grade products comply with GMP regulation for tracking each and every step of the manufacturing process, including raw material sourcing.

Quality control of mRNA stock solution -- Insurance for vaccines

Based on the advantages of experienced mRNA raw enzymes technologies, Novoprotein have developed a series of related detection kits by continuously explored the methods and processes of mRNA synthesis and quality control.

1. Pyrophosphatase, Inorganic ELISA Kit, Cat. No.: PA101

2. RNase Detection Kit

3. NovoFast dsRNA ELISA Kit（Cat. No.: RD017）

4. mRNA Capping Detection Sample Preparation Kit（Beads）(Cat. No.:CD001)and mRNA Capping Detection FlashPrep Kit (Cat. No.:CD002)