Services

Start Your Project Now!

Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.

Here's how you can reach us...

Tel:
Email:

Bioburden Testing for Nucleic Acid Drugs

Inquiry

CD Formulation, as a leading company in life sciences research, specializes in providing high-quality testing services for the biopharmaceutical sector. By utilizing advanced technologies and methodologies, we precisely assess the presence of microorganisms in drugs and related materials. This process not only ensures that each product meets stringent safety standards before market release but also assists our clients in continually complying with industry regulations.

Background on Bioburden Testing for Nucleic Acid Drugs

The background for conducting bioburden testing on nucleic acid drugs lies in ensuring safety and efficacy during production and usage. Bioburden testing detects the total amount of microorganisms present on drugs and packaging surfaces, playing a crucial role in sterilization procedures. It helps identify issues during production that might affect sterilization effectiveness and provides scientific evidence for setting appropriate sterilization dosages. Furthermore, this test is part of routine monitoring to ensure that pharmaceutical and biopharmaceutical products consistently meet strict safety standards and quality requirements, mitigating the risk of harmful microorganisms to protect the final product's integrity and consumer safety.

Explore Our Bioburden Testing Services for Nucleic Acid Drugs

Microbial Extraction Methods in Bioburden Testing

Methods	Descriptions
Ultrasonic Processing Method	Through high-frequency vibrations from ultrasound, we effectively disrupt cell structures in samples to release microorganisms. This method is suitable for various complex matrices, ensuring efficiency and completeness in the extraction process.
Mechanical Shaking Method	This method uses mechanical devices or manual operation to separate microorganisms from substances through oscillation and shaking. The process is gentle, adaptable, and can handle a variety of sample types.
Vortexing Method	The vortex method employs centrifugal force generated by strong rotation to separate microorganisms from sample matrices. It's fast and suitable for processing large sample batches, enhancing laboratory testing efficiency.
Stomach Washing Method	Stomach washing technology is mainly applied to hard-to-extract samples by mimicking gastric peristalsis to release microorganisms. It ensures maximum microbial recovery, suitable for analyses requiring high extraction efficiency.

Bioburden Testing Services

Items	Descriptions
Membrane Filtration Method	For samples containing antimicrobial components, the membrane filtration method is the best choice. Samples are first filtered through a 0.45-micron pore membrane, with vacuum assistance to speed up the process. After filtration, the membrane is transferred to a medium for incubation, with bacterial detection at 30-35°C and fungal detection at 20-25°C for no less than five days. Finally, microorganisms are counted to precisely evaluate contamination levels, avoiding false positives from cross-contamination.
Direct Inoculation Method	We provide direct inoculation services, including the pour plate and spread plate methods. The pour plate method, with its higher theoretical precision, involves mixing the test sample with a medium until solidified in a petri dish. The spread plate method involves applying samples directly to the surface of solidified media. After samples are introduced into the culture system, they are incubated for a specific period for precise microorganism counting.
Most Probable Number (MPN) Method	The MPN method is suited for determining the approximate concentration of bacteria in samples through gradual dilution and microbial presence testing. However, multiple repetitions are needed for accurate confidence intervals, and this method isn't suitable for fungal quantification.

Workflow of Bioburden Testing Services for Nucleic Acid Drugs

Fig.1 Nucleic acid drug bioburden testing flowchart. Fig.1 Flow chart of bioburden testing for nucleic acid drugs. (CD Formulation)

Sample Preparation

Place nucleic acid drug samples in specialized test containers and add a certain amount of sterile rinse solution, usually a buffered aqueous solution, to enhance microbial suspension efficiency.

Microbial Extraction

Choose appropriate agitation methods based on the drug material's characteristics to remove surface microorganisms.

Extract Processing

After extraction, collect the extract, preparing it for separate culture to independently detect different types of microbial contamination.

Culture and Detection

Extracts are usually processed through filtration or pour plate methods to cultivate the extracted microorganisms. The results are then analyzed in detail and microorganisms are counted.

Result Analysis and Reporting

Analyze the obtained data to evaluate the bioburden status of nucleic acid drugs and provide detailed test reports.

Our Advantages of Bioburden Testing Services for Nucleic Acid Drugs

We utilize the most advanced extraction and detection technologies for precise identification and counting of microorganisms in nucleic acid drugs, providing highly accurate test data.
Tailor testing plans according to client's specific needs and product characteristics, ensuring each test phase aligns with the product's actual situation.
Every testing process strictly adheres to industry standards and regulatory requirements, helping clients ensure that their products comply with all necessary safety and quality standards before market entry.
Our efficient testing process guarantees analysis completion in the shortest time, quickly delivering results and reports to support clients in making timely production and quality decisions.

Publication Data

Technology: Analysis of biotech-derived products utilizing bioburden test platforms

Journal: European journal of pharmaceutics and biopharmaceutics

IF: 4.4

Published: 2024

Results:

This paper emphasizes a holistic approach to managing bioburden risk in thermolabile parenteral drugs that can't undergo terminal sterilization. Key findings highlight the need for control and monitoring before filter sterilization, proposing a bioburden limit as an action threshold. It suggests integrated risk assessments to address pre- and post-filtration risks, advocating a two-tier monitoring system with adjustable levels based on product history. The study underscores the importance of evaluating bacterial by-products' impact on safety and recommends smaller sample volumes for highly controlled manufacturing processes. Overall, bioburden testing serves as a verification tool for the effectiveness of microbial control measures.

Fig.2 Performance attributes of bioburden analysis. Fig.2 Performance characteristics of bioburden testing. (Bechtold-Peters K, et al., 2024)

CD Formulation is committed to supporting clients in achieving excellence in product development and production through comprehensive and reliable bioburden testing. We adhere to strict regulatory guidelines to minimize microbial risks. If you wish to learn more about our bioburden analysis services for nucleic acid drugs, please feel free to contact us.

References

Bechtold-Peters K, Chang S, Lennard A C, et al. Risk-based approach to setting sterile filtration microbial bioburden limits-Focus on biotech-derived products. EUR J PHARM BIOPHARM. 2024, 198: 114151.

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.

Related Services