Microbiology Testing
Microbiology testing is an important requirement for the bioanalytical method development in the biologics manufacturing which involves a variety of testings. With our comprehensive menu of microbiology services, our expert teams can provide services across the product development lifecycle. BOC Sciences provides independent microbiological testing services including assessment of microbial contamination, quality control testing, shelf life testing.
Figure 1. Nucleic Acid Detection of SARS-CoV-2 Using CRISPR/Cas Assays. (Uyanga, G; Changchun, L. 2020)
Our Services
To make it easier and better for researchers, BOC Sciences provides microbiology testing service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
- Microbial Identification
BOC Sciences can accurately identify microbial contaminants bu employing a variety of advanced instruments to help our customers make adjustments to their biologics manufacturing processes to avoid contamination
- Pharmaceutical Testing
Our team offers a series of microbiology laboratory testing services, including bacterial endotoxin testing, biological indicator testing, VHP sterility testing, and in vitro microbial kill rate studies. These tests can help you confirm that no endotoxins are present in your manufacturing process
- Medical Device Testing
To ensure that medical devices are sterile during the production process, we offer sterility testing, bioburden verification and testing, and bacterial endotoxin testing
- Cleanrooms
BOC Sciences provides on-site microbiological air and surface environmental monitoring services for cleanrooms and other controlled environments, and ensures that your sites are properly maintained
- Utility Testing
Our microbiological testing services include complete compressed air and purified water testing services with a fast turnaround time. Our experienced staffs can help you determine the specific tests you need and assist you with sample collection
- Contamination Response Investigations
Our team is capable of responding to biofilm formation, disinfectant neutralization, efficacy verification, cleanroom validation
Microbiology Testing Support
Sterile Products
- Bioburden: Determines the number of viable aerobic microorganisms and the sterilization dose required for sterility testing
- Sterility: We perform sterility testings along with bacterial/fungal inhibition testings to assess whether the test product has an inhibitory effect on the growth of microorganisms
- Endotoxin testing: BOC Sciences supports gel-clot, kinetic turbidimetric and chromogenic assays as qualitative testings. We offer initial screening and validation of products. In addition, in vivo pyrogen and monocyte activation testing (MAT) are available for materials that are not suitable or sufficient for endotoxin testing
Non-sterile products
- Microbial limit testing: We conduct it to allow quantitative enumeration of bacteria and fungi that may grow under aerobic conditions
- Preservative efficacy testing
Other microbial testing capabilities
- Cytotoxicity: Testing for the presence of toxins in medical devices and their components or raw materials
- Water analysis: Quantification of total viability and coliform counts required for process water
- Mycoplasma: Determine the presence of mycoplasma in test articles (culturable and non-culturable agar, and PCR)
- Mycoplasmosis: Determine if the test article inhibits the growth of mycoplasma
- Spirochetes: Detect the presence of spirochetes in the test article
- Mycobacteria: Determine the presence of mycobacterium in the test article, which is important for vaccine products
- Disinfectant testing: Verify the effectiveness of disinfectant procedures in cleanrooms or other controlled areas
- Antibiotic testing: Assess the efficacy (or activity) of antibiotics by their inhibition of microorganisms
- Environmental monitoring
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of microbiology testing at competitive prices for global customers. Personalized and customized services of microbiology testing can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Uyanga, G; Changchun, L. CRISPR-Based COVID-19 Testing: Toward Next-Generation Point-of-Care Diagnostics. Frontiers in Cellular and Infection Microbiology. 2020.
