Company Categories: Consulting Services, CRO, Drug Delivery Systems and Drug Development
Microbiological Contract Research
DetailsAntiinfectives Intelligence is a leading microbiological contract research provider specialising in comprehensive antimicrobial testing and packaging safety services for pharmaceutical products, medical devices, and healthcare products.
Utilising state-of-the-art methodologies and technologies adhering to international ISO and CLSI standards, Antiinfectives Intelligence collaborates closely with clients across the pharmaceutical and medical sectors to provide customised solutions for microbiological safety and efficacy testing that safeguard patient health.
Packaging Safety and Antimicrobial Efficacy Testing
Aii focuses on two primary service areas: comprehensive packaging and material testing and advanced antimicrobial resistance testing. These services are integral for pharmaceutical, biotech, and healthcare industries aiming to ensure the safety, efficacy, and regulatory compliance of their products.
Packaging and Material Safety Testing
Repeated use of medical containers such as nasal sprays, eye drops, and inhalation sprays can pose a risk of contamination. Antiinfectives Intelligence offers specialised testing services to ensure that these products remain safe throughout their usage period. By assessing the integrity of containers and their resistance to microbial contamination, the company helps manufacturers prevent risks associated with infections and compromised product efficacy.
Oligodynamic Testing: This powerful method assesses the antimicrobial properties of materials, particularly those infused with silver ions, which are widely used in pharmaceutical packaging and medical devices to inhibit microbial growth. By evaluating the oligodynamic effect of these materials, Aii ensures that products are effectively protected against microbial contamination, thus enhancing their safety and efficacy during prolonged use.
Dynamic Tightness Testing: This test evaluates the potential contamination of both the initial dose and contents of containers when exposed to test organisms. It is crucial for multi-dose products like nasal sprays and eye drops to confirm their prolonged safety.
In-Use Testing for Long-Term Product Safety: This test validates that medical containers continue to provide a sterile barrier even after repeated use, protecting the contents from microbial contamination. This testing is particularly important for multi-dose products used over an extended period.
Pharmaceutical Aerosol Testing: This service evaluates the packaging of pharmaceutical aerosols, such as nasal sprays and inhalers, ensuring effective filtration of airborne particles or pathogens. It is particularly vital for nasal sprays with air-filtering matrices to validate their safety and sterility under the stress of aerosol delivery. Aii’s testing ensures compliance with regulatory standards, enhances product reliability, and supports the development of safe aerosol delivery systems.
Microbial Safety Testing of Formulations: Beyond container integrity, it is vital to assess whether the formulation itself could inadvertently promote microbial growth. The Nutritive Properties Testing service offered by Antiinfectives Intelligence evaluates the impact of a product’s formulation on microbial proliferation. By using specified test organisms, as defined by the European Pharmacopoeia (Ph. Eur.), the company ensures that formulations are safe for prolonged use without encouraging contamination.
Testing of Plastics and Non-Porous Surfaces: With expertise in the testing of plastics and non-porous surfaces, the company evaluates packaging materials for their ability to resist microbial colonization. These assessments are essential for industries relying on materials that come into frequent contact with sensitive formulations or medical devices.
Antimicrobial Resistance Testing
Antimicrobial resistance (AMR) is one of the most significant threats to global health today. AntiInfectives Intelligence is at the forefront of this challenge, offering an extensive array of antimicrobial resistance testing services to support the development of new antibiotics and antimicrobial agents. The company has a unique collection of over 20,000 bacterial isolates, allowing for detailed resistance profiling and efficacy assessments.
Key antimicrobial resistance testing services provided by Aii include:
Microbroth Dilution: This method is the gold standard for determining the Minimum Inhibitory Concentration (MIC) of antibiotics against specific bacterial strains. By accurately identifying the lowest concentration required to inhibit bacterial growth, Aii helps clients develop more effective antimicrobial therapies.
Agar Dilution and Disk Diffusion Testing: These techniques assess the susceptibility of bacterial isolates to various antibiotics. Agar Dilution provides a precise measurement of MIC on solid media, while Disk Diffusion Testing offers a quick and effective way to screen antimicrobial efficacy by measuring zones of inhibition around antibiotic-impregnated disks.
Gradient Testing: A variation of the disk diffusion method, gradient testing uses antibiotic strips with varying concentrations to directly determine the MIC on an agar plate. This method is valuable for quantifying antimicrobial potency while providing visual confirmation of efficacy.
Minimal Bactericidal Concentration (MBC) Testing: While MIC testing identifies the lowest concentration needed to inhibit bacterial growth, MBC testing goes further to determine the concentration required to kill 99.9% of bacterial cells. Aii’s expertise in MBC testing provides critical data for the development of drugs that aim to eliminate pathogens, reducing the risk of recurrence and resistance development.
Time-Kill Assay: AntiInfectives Intelligence also offers Time-Kill Assays, which are dynamic tests designed to evaluate the rate at which an antimicrobial agent can kill bacteria over a set period. By exposing bacteria to specific concentrations of an antimicrobial agent and measuring the bacterial count at different time intervals, Aii provides insights into bactericidal activity over time, crucial for optimising dosing regimens, as well as concentration-dependent and time-dependent killing effects, helping clients refine their drug formulations for maximum efficacy.
This detailed data enables pharmaceutical companies to design more effective treatment protocols and optimise their drug formulations to achieve faster and more reliable patient outcomes.
Specialised Microbiological Testing
AntiInfectives Intelligence offers specialised microbiological tests to further evaluate the efficacy of antimicrobial materials and formulations. Kill-Kinetics Studies focus on measuring how quickly antimicrobial agents can inactivate bacterial populations. By assessing kill rates, Aii provides valuable data on the speed and efficacy of antimicrobial products, which is essential for developing rapid-acting treatments.
Tailored Microbiological Research
Antiinfectives Intelligence prides itself on offering customised solutions to meet the unique needs of its clients. From pharmaceutical companies to medical device manufacturers and research institutions, the company tailors its services to address specific challenges, ensuring optimal outcomes and client satisfaction. This personalised approach distinguishes Antiinfectives Intelligence as a trusted partner in microbiological research and quality control.
Multicenter Studies for Clinical Validation
In addition to laboratory testing, AntiInfectives Intelligence supports clients through Multicenter Studies, which are crucial for validating the safety and efficacy of new antimicrobial therapies. These studies involve multiple clinical sites and large patient cohorts, ensuring robust and reliable data for regulatory submissions. Aii’s expertise in managing multicenter studies enables pharmaceutical companies to accelerate the approval process and bring innovative antimicrobial solutions to market faster.
Training and Knowledge Dissemination
Antiinfectives Intelligence is committed to advancing scientific knowledge and industry best practices. The company offers training programs designed for students, researchers, and professionals, helping them build expertise in microbiological methods. Additionally, Antiinfectives Intelligence engages in scientific publications and conference presentations, sharing their findings and promoting scientific dialogue within the microbiology community.
About Antiinfectives Intelligence
Headquartered in Cologne, Germany, Antiinfectives Intelligence is a global leader in contract research, policy advisory, and strategic consulting in the realm of anti-infective therapies. Since its founding in 2000 as a spin-off from the University of Bonn, the company has maintained a commitment to excellence in microbiology, helping pharmaceutical and medical device manufacturers navigate the complexities of product safety, regulatory compliance, and scientific innovation.
Antiinfectives Intelligence brings together scientific expertise, data analytics, and industry insights to realise the most effective strategies for the development, regulation, and stewardship of antibiotics and other anti-infective agents. The company’s expertise is trusted by leading pharmaceutical manufacturers, including Pfizer, GSK, MSD, Shionogi and others, to ensure their products meet the highest safety standards and advance public health.
ProductsDownloadsVideosPress ReleasesContactAntiinfectives Intelligence GmbH
c/o Rechtsrheinisches Technologie- und Gründerzentrum
Gottfried-Hagen-Straße 60-62
51105 Cologne
GermanyPhone: +49 221 16995085
