How to Prevent Nucleases contamination?

Deoxyribonuclease (DNase) and ribonuclease (RNase) are hydrolases that can cleave the phosphodiester bond of polynucleotide chains to degrade DNA and RNA molecules. Nuclease widely exists in the environment, materials, and consumable surfaces. During the production process of biological products, there is also a high possibility of residual nuclease residue and contamination, including endogenous RNase contamination in biological samples, as well as exogenous contamination from water, buffers, consumable surfaces, environmental microorganisms, and humans. Moreover, nucleases typically possess strong activity, and even trace amounts of DNase/RNase contamination can cause significant degradation of DNA/RNA, thereby affecting experimental and production processes.

With the boom of the biopharmaceutical industry in recent years, an increasing number of biological products are used for disease prevention and treatment. Technologies such as mRNA, cell and gene therapy, and virus vector-based vaccines have been widely used. While there is great anticipation for the astounding effects of these new technologies, the market has also raised higher requirements for the quality and safety of biopharmaceutical products. Various regulations and policies have been introduced to ensure product safety and control impurity residues. The 2020 edition of "Pharmacopoeia of the People's Republic of China" specifically mentions the need to control process-related impurities, including nuclease, in the R&D and production of the biologics in sections "General Instructions on Vaccine for Human Use", "General Instructions on Recombinant Monoclonal Antibody Products for Human Use", "General Instructions on Gene Therapy Products for Human Use", and "Technical Guidelines for the Research and Evaluation of Cellular Therapeutic Products”.

As a supplier of bioprocessing products, BioLink is pleased to introduce the DNase-free and Nuclease-free single-use consumables, in addition to the existing RNase-free consumables under the NovaLinX^® series. These products aim to address the concerns of potential DNase/RNase contamination during drug manufacturing processes, making the elimination of DNase/RNase more efficient, convenient, and cost-effective.

BioLink's innovative product, RNase-free bag, launched this time, feature a patented design of "master bag + satellite bag"， which ensures 100% DNase/RNase testing release and provides a perfect solution for customer retention testing.

The master bag and satellite bag have the same material and production environment, and undergo consistent gamma irradiation conditions after packaging. After irradiation, satellite bag-1 is used for the release of nuclease detection products, and satellite bag-2 is used for nuclease detection before use or retesting after use. The worst case for the satellite bag extraction ratio can be used to represent the nuclease level in the master bag.

Features for NovaLinX^® RNAse-inhibiting bags

▶ Master bag + Innovative design of double satellite bags

▶ Identical materials/production environments of master bag and satellite bags

▶ Satellite bag-1 (QC release) is used for nuclease detection before product release

▶ Satellite bag-2 (customer retention) is used for customer sampling verification

▶ Different specifications/models of single-use bioprocess products are already covered (such as storage bags, bioreactor bags, cell bags.)

▶ The production environment is typically for the single-use bioprocess consumables - ISO Class 7 cleanroom

▶ Environmental monitoring bags (monthly testing to monitor the nuclease level in the production environment) - produced on the last day of the month on the production line (Worse Case)

NovaLinX®	Nuclease	Storage bag	Storage bottle
DNase-free	DNase-free	5 ml-50 L	5 ml-2 L
RNase-free	RNase-free
Nuclease-free	DNase-free & RNase-free

Relate Product：https://www.biolink.com/products/novalinx-rnase-free-single-use-bioprocess-bags/

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