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Safety Analysis for Nucleic Acid Drugs

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As a provider of advanced preclinical development services, CD Formulation's scientists understand the sensitive and ever-changing landscape of nucleic acid drug development. We utilize superior analytical platforms and technologies for safety analysis of nucleic acid formulations to consistently meet our clients' needs at every stage of development.

Why Nucleic Acid Safety Analysis?

Nucleic acid drugs, as an emerging class of therapeutic products, have chemical structures and mechanisms of action that are very different from those of traditional drugs, which increases the complexity and importance of their safety assessment. Nucleic acid drugs require rigorous safety analyses during development and application. The reasons for conducting these analyses include, but are not limited to, the following.

Ensuring Drug Safety

The metabolism and distribution of nucleic acid-based drugs in the body, as well as potential side effects, need to be thoroughly evaluated. Safety analysis helps identify potential toxicity and other adverse effects, ensuring patient safety.

Compliance with Regulatory Requirements

Drug regulatory agencies around the world have strict requirements for safety assessments during the development of new drugs. Conducting a standardized safety analysis is an important step in obtaining marketing authorization for a drug.

Therapeutic Efficacy Assessment

Safety analyses for nucleic acid drugs also help assess their therapeutic efficacy and applicability, aiding in determining the optimal dosage and mode of use for the best therapeutic outcomes and lowest risk.

Fig.1 Why nucleic acid drug safety analysis. Fig. 1 Benefits of nucleic acid drug safety analysis. (CD Formulation)

Explore Our Nucleic Acid Safety Analysis Services

At CD Formulation, we understand the critical importance of safety assessment in the development of nucleic acid-based therapeutics. Utilizing state-of-the-art analytical techniques and in-depth industry knowledge, our team of experienced experts provides comprehensive safety analysis services tailored to the specific needs of our clients. Safety analysis helps ensure quality control of products during manufacturing, preventing contamination and formulation process defects.

Items	Descriptions	Our advantages
Particulate Matter Analysis	We accurately detect and analyze the particulate matter content of pharmaceuticals using advanced equipment, such as high-resolution microscopes and laser particle sizers.	We utilize cutting-edge imaging technologies and algorithms to guarantee high accuracy and reproducibility of test results. This enables us to promptly address various customer requirements and deliver personalized services.
Sterility Testing	Combining traditional cultural methods with modern PCR techniques, we comprehensively test the sterility of nucleic acid drugs.	Our laboratories are equipped with stringent sterility control measures, and our testing procedures have been validated numerous times to ensure the accuracy and reliability of sterility testing.
Bioburden Testing	We utilize membrane filtration and direct inoculation methods to accurately determine the microbial load of drugs.	Our instruments are highly sensitive and can detect very low numbers of microorganisms, significantly enhancing the sensitivity and specificity of the test.
Bacterial Endotoxin Testing	Rapid and accurate detection of endotoxin levels can be achieved using the LAL method or recombinant Factor C test kits.	Our endotoxin testing process has been optimized multiple times to ensure accurate and reproducible results, while also delivering rapid outcomes to meet urgent customer requirements.

Our Analytical Technology Platforms for Nucleic Acid Drugs Safety Analysis

At CD Formulation, we pride ourselves on our strong commitment to quality, innovation, and customer satisfaction. Our team of experienced experts and state-of-the-art analytical technology platforms enable us to provide unparalleled safety analysis services for nucleic acid-based therapeutics.

Gel Electrophoresis Platform

Accurately assess the purity and integrity of nucleic acid molecules.

Liquid Chromatography-Mass Spectrometry (LC-MS) Platform

In-depth characterization of molecular structure and impurities.

Circular Dichroism (CD) Spectroscopy Platform

Evaluate the secondary and tertiary structures of nucleic acid compounds.

Differential Scanning Calorimetry (DSC) Platform

Determine the thermal stability and potential degradation pathways.

Cellular Assay Platform

Evaluate biological activity and potential cytotoxicity.

Our Workflow of Nucleic Acid Safety Analysis Services

Fig.2 Analysis of nucleic acid drugs' safety workflow. Fig. 2 Workflow of nucleic acid drug safety analysis. (CD Formulation)

Sample Preparation

Samples are handled and prepared in advance to ensure the integrity and stability of the testing materials.

Performance Characterization

A detailed analysis of the physical, chemical, and biological properties of nucleic acid compounds, including their potential structural and functional features.

Impurity Identification

Comprehensive identification and quantitative analysis of potential impurities and degradation products in the drug are essential to ensure the sample's purity.

Stability Assessment

A systematic evaluation of the stability of compounds under various storage and environmental conditions is essential to determine their long-term effectiveness.

Biocompatibility Testing

The biocompatibility of compounds is assessed through cytotoxicity and immunogenicity tests to ensure their safety for living organisms.

Comprehensive Risk Assessment

This evaluation comprehensively assesses the overall safety and potential risks of nucleic acid drugs by synthesizing various analytical data, thereby providing a scientific basis and support for decision-making.

Why Choose Us for Nucleic Acid Safety Analysis?

Comprehensive Analytical Technologies

Particulate matter analysis using advanced instrumentation and techniques.
Comprehensive sterility testing following international standards such as the European Pharmacopoeia (EP), United States Pharmacopoeia (USP), etc.
Accurate bioburden testing to detect the number of viable bacteria in drug samples to ensure the quality of the drug product.
Highly sensitive bacterial endotoxin testing using techniques such as gel and photometric methods.

Strict Quality Control

Strict SOPs are in place for each testing step in nucleic acid safety analysis to ensure standardization and traceability of the testing process.
We have established a comprehensive internal and external audit mechanism to ensure the credibility of the results.

Publication Data

Technology: Enhancing the safety of LNA miR-221 inhibitors using phosphorothioate modification technology

Journal: Journal of hematology & oncology

IF: 8.731

Published: 2023

Results:

The authors developed a 13-oligomer-locked nucleic acid (LNA) miR-221 inhibitor (LNA-i-miR-221) with a backbone fully modified by phosphorothioate (PS). This drug down-regulates miR-221, shows anti-tumor activity against human xenograft tumors in mice, and displays good toxicokinetics in rats and monkeys. Heteroscedastic cross-species scaling enabled the authors to determine a first-in-class safe starting dose of LNA-i-miR-221 for clinical translation.

Fig.3 Safety testing of LNA miR-221 selective inhibitor Fig. 3 CONSORT diagram for LNA miR-221 inhibitors. (Tassone P, et al., 2023)

CD Formulation's deep industry experience and commitment to continuous improvement ensures that we remain at the forefront of providing state-of-the-art solutions to our clients. Contact us today to learn how we can support your nucleic acid drug safety analysis needs and help you bring your formulations to market.

Reference

Tassone P, Di Martino M T, Arbitrio M, et al. Safety and activity of the first-in-class locked nucleic acid (LNA) miR-221 selective inhibitor in refractory advanced cancer patients: A first-in-human, phase 1, open-label, dose-escalation study. J HEMATOL ONCOL. 2023, 16(1): 68.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.

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