Sterility testing is used to confirm that sterile products are free of viable microorganisms before release and clinical use. It is one of the key testing procedures in the GMP microbiological testing requirements and the ICH Q6B guideline. Reliable sterility test method development and validation is a critical step in the biopharmaceutical development process. CD Formulation has a strong track record in supporting the protein and peptide biopharmaceutical industry in cell line, intermediate, and final product testing. Our cGMP testing laboratory provides comprehensive sterility testing services, including but not limited to testing for sterility, endotoxins, microbial limits, dosage unit uniformity, and particulate matter.

Sterility & Sterility Testing

Sterility refers to the complete absence of live microorganisms or microorganisms with the potential to reproduce. Sterile drug products are usually sterilized chemically or thermally after being placed in the final packaging.

Sterility testing of protein and peptide biopharmaceuticals is used to evaluate the live microorganisms in sterile drug products and is intended to confirm that the microorganisms have been properly removed from the product by aseptic processing or that the microorganisms have been effectively killed by the terminal sterilization method. It is important to note that sterility testing is performed at time zero (immediately after manufacturing) and after stability testing over a period of time (such as 6 months or a year).

Explore Our Sterility Testing for Proteins & Peptides Formulation Services

CD Formulation strictly adheres to cGMP requirements and supports sterile and non-sterile therapeutic protein and peptide product testing to help you determine whether its production batch is sterile and verify whether the sterilization method adopted can effectively and consistently sterilize the therapeutic protein and peptide products.

We have a strong quality infrastructure, strict control measures, and sterility testing areas to support CGMP testing according to USP and EP methods to avoid contamination of sterile samples and false positive results.

Pharmacopeia sterility testing of biopharmaceutical products such as proteins, peptides, etc., is based on adding aliquots or membranes of concentrated samples to different types of culture media. Our team of microbiologists provides two sterility testing methods based on pharmacopeia definitions.

Membrane Filtration Method

In this method, the effluent of the protein or peptide drug product to be tested is transferred to a cellulose nitrate or cellulose acetate membrane filter that is capable of retaining microorganisms. Depending on the product to be tested, specially adapted membranes may be used. The filter is then transferred to two specific nutrient test media and incubated for 14 days.

This method is applicable to soluble solids, ointments, creams, antibiotic solids, aerosol products, etc.

Direct Inoculation Method

In the direct inoculation method, the protein or peptide drug product to be tested will be in direct contact with the test medium throughout the incubation period. The protein or peptide sample or sample portion (SIP) is immersed in the test medium and incubated for 14 days to allow the microorganisms present in the sample, if any, to grow and multiply under ideal conditions.

This method requires less sample volume.

In addition to the established culture-based methods, we provide four different rapid methods available, including:

• Respirometry pressure sensing technologies, detection of metabolic activity is determined by pressure transients relating to gaseous exchanges within the closed culture vessel as a result of microbial respiration.
• Growth-based carbon dioxide detection, where detection indicates the presence of viable microorganisms.
• ATP bioluminescence, where luciferin/luciferase enzyme reagent catalyzes the conversion of microbial adenosine triphosphate (ATP) into adenosine diphosphate (ADP) and light.
• Viability staining and solid phase cytometry, post staining, the detection of microbes is achieved using digital fluorescent microscopy at specific excitation and emission wavelengths.

Complementary Sterility Testing Services

To perform sterility testing more thoroughly and ensure product reliability, we also provide two additional tests to supplement sterility testing, including:

Bacteriostasis/Fungiostasis Testing – B/F Testing

In conjunction with sterility testing, bacteriostasis and fungistasis testing are also performed to evaluate whether the test article inhibits the growth of microorganisms. B/F testing must be performed to verify the sterility results and confirm that there are no antimicrobial properties in the test article that would inhibit the detection of microorganisms during the sterility test.

Vaporized Hydrogen Peroxide (VHP) Intrusion Testing

Vaporized hydrogen peroxide (VHP) intrusion testing is performed in an isolator that has been decontaminated with VHP. This test evaluates whether VHP has significantly invaded the test article container.

Our Sterility Validation Services

In addition to the necessary sterility testing, we also provide sterility testing validation services to ensure that your products meet the relevant sterility standards and regulatory requirements so that your products can be delivered to patients faster. The following figure is our general sterility validation flow chart:

Fig.1 Workflow of Sterility testing validation. (CD Formulation)

Why Choose Us for Sterility Testing of Proteins & Peptides Formulation

• We have extensive expertise and experience in performing sterility testing and sterility validation for protein/peptide biopharmaceuticals.
• Our sterility testing methods support multiple regulations, including USP, EP, JP, and PTC.
• We are equipped with a state-of-the-art microbiology laboratory to ensure high standards of contamination-free testing for your protein/peptide products.
• We can perform GMP-compliant microbiological testing on any sterile and non-sterile protein/peptide final products, including injections, aerosols, and topical products.
• We provide flexible and tailored solutions to meet our customers' specific needs and requirements.
• Fast and efficient services ensure that our customers' projects are delivered on time.

Publication

CD Formulation is committed to providing you with powerful sterility testing analytical tools to help you develop protein or peptide formulations, ensuring they meet regulatory requirements. Our team has extensive experience and expertise in designing and executing specialized experimental protocols based on customer needs, including sterility testing, sterility validation, endotoxin testing, microbial limit testing, etc. Please feel free to contact us if you are interested in our services. We will provide you with the best solutions and support.