iuvo BioScience is headquartered in Rush, NY and maintains a 30,000-square-foot preclinical laboratory testing facility that offers on-site AAALAC accredited vivarium and specialty testing services for the medical device and pharmaceutical industries. iuvo has a talented team whose breadth of testing and consulting expertise spans multiple disciplines including Analytical Chemistry, Microbiology, Toxicology, and Sterilization within the medical device and pharmaceutical industries. Our experience is particularly deep serving the ophthalmics industry, including for OTCs, drugs, devices and combination products.
iuvo offers sterilization validation services with extensive experience in ethylene oxide sterilization, as well as gamma and E-beam. Our scientific staff has years of involvement on the AAMI Standards Committees for resusable device cleaning, disinfection and validation and are able to provide consultation as well as testing services.
Our model is to take service beyond a typical CRO, providing a Partner Research Organization to work with you throughout your development program. Reach out to us to experience the difference working with a PRO can make.
Effective July 1, 2018, Oculos Clinical Research is now part of the iuvo family. A leading provider of clinical research (CRO) services for the ophthalmic industry, we now offer a fully integrated suite of services to support ophthalmic clients (medical device, pharmaceutical, biotech, diagnostics) to bring their products to the market...from Research to Release.
Iuvo BioScience has over 30 years of expertise in designing and conducting biocompatibility programs for a range of medical device types. With regulatory and scientific expertise in global medical device development, we provide focus and efficiency to the often complex registration process. Our consultant team has been intimately involved in successfully preparing numerous medical device regulatory submissions and serving as the interface with the FDA to gain timely product registration. Our collaborative approach and deep understanding of both the science and the regulatory guidelines positions us to provide the best strategies that both accelerate timelines and reduce program risk. As your partner, you will get the full support of our expertise through-out the life cycle of your product.
Our medical device consulting services include:
We also serve as representatives on teams or at meetings with regulatory agencies. In addition our Quality / Regulatory consultant group can implement Design Control as part of your product development and our analytical consultants can provide expert advice on the characterization of your materials.
Ophthalmic drug development is different.
At iuvo BioScience, our team of ophthalmic scientists know the eye, its compartmental structure and function, and the unique technical and regulatory challenges that ocular pharmaceutical development presents. To help you develop your ophthalmic product, we can partner with you in the following areas:
Iuvo BioScience offers a suite of general toxicology studies ranging from non-GLP dose ranging studies to GLP-compliant repeat-dose toxicology studies. We can conduct standard ICH –compliant testing or alternatively will design tailored custom studies for the assessment of toxicological effects. Our general toxicology studies range from single dose through repeat dose evaluation in rodent species using multiple routes of administration including oral, IV, dermal topical ocular, and intravitreal. Our expert preclinical team provides consistently high quality on-time reports with full regulatory compliance to support your research programs as well as your Regulatory submissions.
iuvo offers a comprehensive suite of in vivo services for Biologics. Our scientists have years of experience with in vivo potency studies, vaccine challenge studies including the use of BSL-2 organisms, immunogenicity as well as lot release testing. We are experienced in delivering the test material through a number of routes including tracheal, nasal, ocular, oral, rectal as well as the more traditional parenteral methods.
iuvo scientists can work with you to develop individual test protocols or comprehensive test programs with our expertise in delivering the biologic and collection of samples.
Iuvo BioScience performs routine on-site testing for the evaluation of viable and nonviable contamination in cleanrooms.
Our trained staff offers consultation regarding cleanroom validation, maintenance, and risk assessment to ensure compliance to current standards as specified in ISO 14464-1, ISO 14464-2, USP <1116>, USP <797> and USP <800>. Our services include supplying the appropriate growth mediums (contact and fallout plates), incubation and enumeration of samples, as well as performing testing and providing detailed reports. The sponsor may request samples for speciation or gram stain.
The bacterial endotoxin test evaluates the level of lipopolysaccharide (LPS), also known as endotoxin, present on or in a material or substance. LPS is known to cause a febrile response in humans therefore is important to monitor manufacturing processes, including water systems, for the presence of LPS. The BET is used routinely as a release test for medical devices and pharmaceuticals.
Confirming sterility is a key concern for both medical device and pharmaceutical products. iuvo specializes in the microbiology associated with compendial sterility, including USP 71 and ISO 11737-2, with special emphasis on medical devices, ocular products, pharmaceuticals and a wide variety of Biological Indicators used in the device sterilization industry. Our team has extensive experience with the increasing complexity of medical devices, employing a broad range of techniques to evaluate different products (drop methods, membrane filtration, fluid path).
iuvo has decades of experience in studies employing ethylene oxide, steam, dry heat and liquid chemical sterilants, along with electron-beam and gamma-irradiation dose validation studies. As part of our ISO 17025 accredited testing services, our technical staff maintains a high level of expertise by participating in annual training and recertification processes. All of our sterility procedures are performed in a certified cleanroom, including a transfer room that has been classified to ISO Class 7 specifications, within which we perform our transfers in an ISO Class 5 laminar flow hood.
In addition to the many engineering controls, all procedures are strictly controlled to minimize contaminants in the environment where transfers take place. Technique is critical to maintaining reliable testing, since any contamination can ruin a test and operators are always the most common source of contamination. The state of control is evaluated routinely through environmental, personnel and fall-out monitoring to ensure functionality is maintained and meets the requirements specified for cleanrooms in ISO 14644-1 and ISO 14644-2.
Stability studies are designed to assess the impact of time and storage condition (i.e., temperature, humidity) on the quality of active pharmaceutical ingredients and drug products. Iuvo BioScience can provide stability storage for pharmaceuticals stored under ICH-recommended conditions and, furthermore, can support the analytical testing necessary to understand the quality impact of each storage condition as a function of time. In addition to pharmaceutical stability studies, iuvo BioScience is capable of performing similar studies for formulated medical devices.
Sensitization is the ability for a test material to induce allergenicity or sensitization, and is part of the overall ISO-10993 biocompatibility assessment.
Sensitization testing requires multiple applications of the test material or test material extract to determine if the material will induce a hypersensitivity reaction. Over a period of approximately 4 weeks, animals undergo induction, exposure and challenge phases to assess the allergenic properties of the test material.
Safety Testing, used for lot release assessment of Biologics, is a requirement for both domestic and international regulatory bodies. iuvo has decades of experience performing compendial-based release testing as well as customer driven protocol-specific tests. We are able to initiate and release testing quickly to meet our customers’ manufacturing schedules. In addition, we are able to work with our customers during development of a novel material to assess safety.
Accelerated aging studies (sometimes referred to as extended shelf life testing) are performed by iuvo BioScience for clients who wish to be able to market their product more quickly than real-time stability studies would permit.
The design of these studies, which are performed in parallel with real-time aging studies, is based on ASTM F1980, and exposes both products and packaging to extremes of temperature and humidity. iuvo maintains both walk-in incubators and smaller test chambers specifically for these projects. All chambers are equipped with automatic phone-out temperature and humidity alarms, and we maintain an on-site electrical generator to minimize any interruptions in the aging studies. Temperature and relative humidity data are captured and stored electronically over the course of the study.
Combining Accelerated Aging with Product and Packaging Testing
Our package integrity testing program is available to clients who perform the accelerated aging and real-time incubation studies at our facility or elsewhere. Comprehensive capabilities (listed below) of available package testing protocols includes both the standard dye migration and creep to burst physical tests and additional microbiology aerosol challenge tests in which sealed packages are exposed to a suspension of B. atrophaeus and the package contents assayed for ingress of the organism.
In addition, iuvo BioScience is one of the few test facilities able to examine the properties of porous packaging materials by the ASTM F1608 microbial ranking method. In the case of pharmaceutical products, stability indicating analyses of the active ingredients can also be performed.
Package/Container Integrity Verification
This test provides an estimation of total aerobic bacteria and yeasts/molds and absence of designated microbial species in all types of pharmaceutical articles from raw materials to finished products following USP 61 and USP 62.
Related to the microbial limits test, iuvo is able to perform the USP 2021 and 2022 assays, which outline a similar procedure for nutritional and dietary supplements. All assays result in the determination of the total aerobic bacterial and yeast/mold counts, as well as the absence of specific organisms identified as objectionable for each group of test articles.
Regulatory scrutiny of extractables and leachables (E&L) continues to increase, particularly for higher risk pharmaceutical dosage forms in the areas of inhalation products, injectables, ophthalmic solutions and suspensions, and transdermals. As a result, E&L studies are an essential component of pharmaceutical product development.
Extractables typically arise from packaging components or materials used in dosage form manufacturing. Whereas extractables represent compounds that can be aggressively withdrawn from these materials (potential drug product impurities), leachables are those compounds that migrate into drug products under nominal conditions (actual drug product impurities) and thus must be evaluated with respect to their impact on the safety, quality, and efficacy of the affected drug product.
iuvo personnel have over fifteen years of experience in the E&L field with an extensive track record of designing and executing successful E&L studies in support of NDA, ANDA, and post-market approvals (e.g., packaging changes). Members of the technical leadership at iuvo have been active in direction-setting working group organizations such as the Product Quality Research Institute (PQRI).
iuvo BioScience can provide strategic consulting services (E&L study design); study execution using sensitive, selective analytical techniques such as LC-MS and GC-MS; and toxicological safety assessment of leachables. Studies will be performed according to widely accepted principles such as those found in the PQRI, USP (e.g., <1663> and <1664>), and other standards as applicable.
Mammalian tissue culture systems are currently used to evaluate biocompatibility and toxicity of materials for use in medical devices and associated products. Cell culture testing methods have shown good correlation with animal assays and are frequently more sensitive to toxic materials. Several of these cytotoxicity test procedures are widely accepted in biomaterial screening, quality control and audit programs.
In general, these in vitro techniques use a variety of cell types which differ in relative sensitivity and the time required to conduct the assay. Results obtained with cell culture methods must be evaluated in conjunction with supporting or associated in vivo studies and with the end use of the product.
Cytotoxicity tests are required as part of the ISO-10993 test matrix for all medical devices.
Bioburden is the population of viable microorganisms on or in product located within a sterile barrier system. Knowledge of bioburden population is important for a variety of applications, including but not limited to the following:
Measuring bioburden involves a number of extraction and culturing procedures designed to provide knowledge of the number and characterization of the population of microorganisms on or in the product. The extent of characterization is dependent on how the bioburden data is to be used. iuvo has extensive experience evaluating bioburden from various medical device and pharmaceutical products utilizing diverse extraction procedures (mechanical removal, sonication, swabbing and other custom methods) and differential plating for aerobes, spores, fungi and anaerobes.
Further characterization of the bioburden is possible with selective growth media, gram staining, and identification to the species level. iuvo is able to comply with various compendial procedures and international standards (such as ISO 11737-1), as well as specific customer supplied procedures.
Antimicrobial efficacy testing is used to determine the effectiveness of killing microbes. iuvo is able to evaluate the antimicrobial and biocidal activity of various pharmaceutical and ophthalmic products following a number of compendial monographs and international standards.
Our services include the following:
Experienced analytical chemists at iuvo can provide customized HPLC and GC method development for chromatographic assays supporting medical device or pharmaceutical R&D programs. With new method development, we work closely with our customers and the Quality Assurance Department to tailor methods and procedures that meet the specific needs of our customers. Methods can be validated and run routinely by our staff or we can collaborate with our customers to transfer methods. Routine testing performed by our staff is performed on qualified and calibrated instrumentation using controlled procedures to provide our customers with reliable results in a timely fashion.
Method validation services are also available to demonstrate method capability and performance. Method validation conducted at iuvo is compliant with pertinent USP, ICH, and FDA guidelines.
Iuvo BioScience’s expert pharmaceutical consulting team specializes in providing critical input to companies on their preclinical programs to support the development of new pharmaceuticals and their submission to regulatory agencies worldwide. Our collaborative approach and deep understanding of both the science and the regulatory guidelines positions us to provide the best strategies that both accelerate timelines and reduce program risk. We provide a breadth of expertise with our decades of collective years of direct global pharmaceutical Industry experience and treat each project as our own.
Our pharmaceutical consulting services include:
We also serve as representatives on client project teams or at meetings with regulatory agencies.
Sterilization Validation Consulting
Meeting Your Sterilization Needs
iuvo BioScience brings over 40 years of experience to the design and validation of sterilization processes. Our experience includes extensive work on validation of ethylene oxide cycles (including products with temperature, moisture and ethylene oxide sensitivity) as well as validation of radiation, steam and reusable device cleaning validations..
Our knowledgeable, experienced personnel are available to discuss the intended use, design and material composition of your product to assist in determining the extent of processing required.
Members of our team sit on many of the standards setting boards, so we are always on the cutting edge of changes in regulations, helping to provide you the best advice to ensure that you are never unprepared for changing regulations.
The Microbiology Department has been the cornerstone of iuvo’s laboratory services since STS’ inception over 40 years ago. With diverse expertise in both the medical device and pharmaceutical spaces, iuvo will be a trusted partner throughout the life cycle of your project. Our experts sit on various standards boards, such as AAMI and ASTM, and with that comes the assurance that iuvo is always in a position to offer sound guidance rooted in the current industry paradigms.
iuvo’s Microbiology consulting services include:
Analytical Chemistry Consulting
Analytical chemistry is a key discipline in generating understanding of products both under development and already in the marketplace. For those instances where understanding can only be generated by a product-specific, scientifically rigorous testing strategy, iuvo can be your partner in devising analytical strategies to develop that understanding. Our experienced staff will collaborate directly with you to recommend testing strategies aimed at developing the required understanding with an eye toward expediency and the responsible use of resources.
Extractables and leachables (E&L) is one area of analytically-intensive testing that often requires a strategy specifically tailored to the product of interest. By consulting with iuvo BioScience, you can leverage our 15+ years of successful experience in developing E&L testing strategies in the support of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and the assessment of post-market packaging changes.
iuvo BioScience is committed to maintaining the highest level of quality and compliance to international standards, including FDA, ISO 13485, ISO 17025, EU, JPAL, etc. Our long history of strong compliance, combined with new additions such as our 2016 accreditation to ISO 17025, are testaments of our commitment to excellence in Quality and Compliance.
Now, iuvo BioScience has expanded the broad array of technical and laboratory services available to our clients to include offerings in Quality and Compliance. Areas of expertise include the following:
Let us know how iuvo can help support your Quality and Compliance needs.
iuvo BioScience has decades of experience serving the medical device industry, helping medical device companies with all levels of testing. Whether through early stage research; to biocompatibility, stability and aging studies in support of filing for product approval; right through to product release and environmental testing of manufacturing areas, iuvo has experience to help get your product to market.
Although iuvo was founded in 2015, the company continues a tradition of collaborating with medical device companies which started with the company's founding as STS over 40 years ago. In addition, many of our technical leaders sit on the standard setting boards such as AAMI, so we stay up to date on the changing regulations to ensure we can provide you with the best advice on how to effectively take your product to market.
Our experts in toxicology, microbiology, and analytical chemistry are ready to help support your device testing needs and to work with you, hand in hand, through the approval process.
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