NovaLinX^® Nuclease-free Single-use Consumables

NovaLinX^® Nuclease-free Single-use Consumables mainly include storage bottles, satellite bags, and manifold bags. RNase/DNase testing is optional to prevent the potential introduction of RNase/DNase during drug production.

Deoxyribonuclease (DNase) and ribonuclease (RNase) are a class of hydrolase that can degrade DNA and RNA  molecules by severing the phosphodiester bonds of polynucleotide chains. Nucleases are widely found in the environment, on the surface of materials and consumables. In the production process of biologics, there is also a large potential for residues and contamination of nucleases, including endogenous RNase contamination of bi-ological samples, exogenous contamination of water, buffers, surface of consumables, as well as environmental microorganisms and human beings. Nucleases are often extremely reactive, and small amounts of DNase/RNase contamination can lead to significant DNA/RNA degradation, which can have a significant impact on experimen-tal and manufacturing processes.

With the boom of the biopharmaceutical industry in recent years, more and more bioproducts are being used in disease prevention and treatment. Technologies such as mRNA, cellular and gene therapies, and vaccines based on viral vector modification are gradually gaining widespread use. While anticipating the remarkable effects of these new technologies, the market has also put forward higher requirements for the quality and safety of bioproducts. In order to ensure the safety of bioproducts and the control of impurity residues, numerous relevant regulations and policies have been launched. The “2020 edition of the 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 these 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 Thera-peutic Products”.

NovaLinX^® single-use consumables mainly include storage bottles, satellite bags, and manifold bags. RNase/DNase testing is optional to prevent the potential introduction of RNase/DNase during drug production.

Features of NovaLinX^® Nuclease-free Single-use Consumables

Features of Satellite Bag

• Master bag + innovative design of double satellite bags (enabling 100% individual inspection of RNase/DNase-free bags)

• Identical material/production environment of the master bag and satellite bags, consistent gamma irradiation after packaging

• Irradiated satellite bag-1 (QC release): for Nuclease inspection prior to product release

• Irradiated satellite bag-2 (customer verification): for customer verification and review

• The extraction ratio of the satellite bag is at the worst case, which represents the Nuclease level of the master bag.

• Imported 9101 film.

• The production environment is usually an ISO Class 7 clean workshop for single-use bioprocessing consumables.

• Environmental monitoring bag (monthly monitoring of production environment Nuclease level.) - produced on the last day of the month on the production line (Worse Case)

Features of Satellite Bag

• Master bag + innovative design of double satellite bags (enabling 100% individual inspection of RNase/DNase-free bags)

• Identical material/production environment of the master bag and satellite bags, consistent gamma irradiation after packaging

• Irradiated satellite bag-1 (QC release): for Nuclease inspection prior to product release

• Irradiated satellite bag-2 (customer verification): for customer verification and review

• The extraction ratio of the satellite bag is at the worst case, which represents the Nuclease level of the master bag.

• Imported 9101 film.

• The production environment is usually an ISO Class 7 clean workshop for single-use bioprocessing consumables.

• Environmental monitoring bag (monthly monitoring of production environment Nuclease level.) - produced on the last day of the month on the production line (Worse Case)

Why Choose Nuclease-free Single-use Consumables?

Deoxyribonuclease (DNase) and ribonuclease (RNase) are a class of hydrolase that can degrade DNA and RNA molecules by severing the phosphodiester bonds of polynucleotide chains. Nucleases are widely found in the environment, on the surface of materials and consumables. In the production process of biologics, there is also a large potential for residues and contamination of nucleases, including endogenous RNase contamination of biological samples, exogenous contamination of water, buffers, surface of consumables, as well as environmental microorganisms and human beings. Nucleases are often extremely reactive, and small amounts of DNase/RNase contamination can lead to significant DNA/RNA degradation, which can have a significant impact on experimental and manufacturing processes.

With the boom of the biopharmaceutical industry in recent years, more and more bioproducts are being used in disease prevention and treatment. Technologies such as mRNA, cellular and gene therapies, and vaccines based on viral vector modification are gradually gaining widespread use. While anticipating the remarkable effects of these new technologies, the market has also put forward higher requirements for the quality and safety of bioproducts. In order to ensure the safety of bioproducts and the control of impurity residues, numerous relevant regulations and policies have been launched. The“2020 edition of the 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 these 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”.

Specifications of NovaLinX^® Nuclease-free Single-use Consumables

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