Viral Clearance Studies

Viral Clearance Studies

viral clearance studies from the industry leader with unmatched experience and expertise Viral clearance is a critical component of regulatory submissions as it helps demonstrate overall safety of products. Laboratory scale-down models validate your downstream purification process for removal/inactivation of adventitious agents. The design of an effective viral clearance platform is essential for continual success. 25+ Years of Experience Exclusive Data Mining Services WuXi AppTec has the right experience for the nuanced world of viral clearance and a platform to drive higher LRVs Impeccable Regulatory Track Record WuXi AppTec The Industry Leader Study Designs that Result in Higher LRVs Unmatched Technical Expertise Highly Purified Virus Stocks With industry-leading experience and expertise, we understand the unique challenges that different products may encounter, which may lead to unexpected results. Our team has a proven track record of success especially with products for which it can be a challenge to obtaining high LRVs. For over 25 years, WuXi AppTec has been at the forefront of viral clearance studies no one has more experience or a more highly developed program.

study design claim greater log reduction values for your processes YOUR CHALLENGES Designing a robust viral clearances study takes technical horsepower. Inadequate log reduction values can raise regulatory questions. Early-stage studies don t always predict final process results. OUR SOLUTION Using advanced, globally accepted testing approaches, WuXi AppTec s team of experts will design studies that produce better results with higher log-reduction values for your process. Our experienced staff can help design your entire study, assist with the scale-down portions of the project, and then work side-by-side with you during the execution of the study. STUDY EXPERIENCE Products for which we have conducted studies for R&D, Phase 1-3, BLA, Marketing Authorization, and 510K submissions include: Monoclonal antibodies Viral vaccines Recombinant proteins Tissues Blood-derived products Virus removal/inactivation instruments, resins, Gene therapy vectors matrices, and devices PROCESS EXPERIENCE Our experience spans a broad range of different processes, including: INACTIVATION Heat / Pasteurization Low and high ph Solvent / Detergent Irradiation Sterilization High-energy light Ethanol REMOVAL Column chromatography Filtration CLEANING Kinetics of inactivation Coupon studies

high titer, highly purified virus stocks The preparation, purification and use of high-titer viral stocks is one of the most critical aspects in the performance and eventual success of a viral clearance study. WuXi AppTec has conducted extensive research to produce highly purified, high-titer virus stocks for use in viral clearance studies. We have set the standard for how these stocks should be made and the results from our clients studies demonstrate the success of our research efforts. Our ultra-purified stocks help ensure the data generated is the most accurate assessment of your processes ability to clear or inactivate virus. They can also dramatically increase total log reduction values (LRV) for nanofiltration and other steps. The LRV results from utilizing these stocks can often provide the necessary clearance to potentially eliminate low LRV steps, greatly reducing the cost of your viral clearance program and process development efforts. Studies have shown that virus purity has the ability to affect process steps as less-purified virus can cause significant interference. Ultrapurified virus stocks can reduce this interference. Industry Standard Virus Purification MVM Capsid photo using Transmission Electron Microscopy (TEM). Note potential cellular debris, cellular membranes and DNA. Ultra 3 Highly Purified Virus Preparation MVM Capsid photo using Transmission Electron Microscopy (TEM). Note high particle count, mono-dispersed, very little cellular debris. Our experience and proprietary process make for the highest purity stocks on the market With our meticulously developed and higly refined approaches to purification techniques, we have three classifications of virus for use in studies: Ultra 1 (standard) Ultra 2 (highly purified Reovirus, PrV and MuLVs) Ultra 3 (highly purified PPV and MVM) Ultra-pure viruses are purified using centrifugation and other proprietary process steps. Our standardized process mitigates the variation of lots and specially developed quality control assays help characterize the purity.

data mining services Harnessing the power of a vast database to enable clients informed decision-making WuXi AppTec s Viral Clearance Database is a powerful tool allowing users to query for information related to general or specific process step parameters and how those parameters affect viral clearance/inactivation. With database queries, clients are able to make informed decisions prior to or during critical process changes, which, in turn, permits fine-tuning of the processes helping to avoid costly delays and the inclusion of unnecessary or non-ideal process steps in their viral clearance analysis. For example, a query might review the past results of a specific process step prior to implementing a change or as an alternative to an existing process. Alternatively, the database could be mined to examine the performance and effectiveness of specific conditions that could yield better viral clearance log reduction values. 25+ years of testing results 3500+ studies 20,000+ data points Supported Products Include: Recombinant proteins Monoclonal antibodies Tissue and plasma products Gene therapy vectors Vaccines Raw materials Devices Database Features: More than 3500 different viral clearance or inactivation studies Information tabulated from 20,000 data points and continuously expanding Log reduction values obtained over a 25-year span Extensive library of inactivation and removal process steps Multiple Search Criteria Include: Process step (AEX chromatography, solvent/detergent, nanofiltration) Virus used (over 30 different types) Process step parameters (ph, flow rate, conductivity) Protein and viral load Infectivity or PCR detection methodology General scale-down parameters for individual processes

large-volume testing + virus plaque assay The targeting of robust processes with large volumes of product fractions and filtrates coupled with use of the virus plaque assay has been shown to consistently drive claims of higher log-reduction values for your purification processes. large-volume testing WuXi AppTec has performed many large-volume studies for clients, which have clearly demonstrated that a higher log-reduction value can be realized for a given process step. By testing large volumes of product material in viral clearance studies (e.g., testing a level of filtrate in quantities upwards of >200 ml), your program is best positioned to drive higher log-reduction claims through increasing the sensitivity of the assay so that a greater log reduction can be achieved. virus plaque assay The Virus Plaque Assay is a quantitative virus detection technique preferred for the benefits it yields in driving higher log-reduction values for viral clearance studies. Easily amplified to accommodate large-volume testing, the Virus Plaque Assay has proven to be a more precise method than TCID 50 for detection of infectious units for most viruses, and it facilitates the claim of more log reduction for most processes. spike based on total viral input Historically, all steps for a viral clearance study have been performed on a percent spike basis. WuXi AppTec is defining a new approach to viral clearance study design by transitioning from a percent spike methodology to a total viral load application for all steps. LARGE -VOLUME TESTING Higher Log- Reduction Value + VIRUS PLAQUE + TOTAL VIRAL ASSAY LOAD APPROACH EQUALS More Consistent Data Better Reliability Scientifically sound study designs save time, materials and money by reducing the number of process steps evaluated while maximizing the log reduction values obtained for those steps. You can have confidence in methods that decrease assay variability, ensure reproducibility, and meet global regulatory needs.

program highlights Our unmatched experience and expertise, plus exceptional program features can dramatically affect your process development efforts and help ensure your study success. WuXi AppTec is the industry leader in viral clearance studies Impeccable Regulatory Track Record More than 25 Years of Experience Unmatched Technical Expertise Study Designs that Result in Higher LRVs High Titer, Highly Purified Virus Stocks Exclusive Data Mining Services Continuous Processing Option Expanding and Flexible Capacities We have performed more than 3500 viral clearance studies and never had a single study rejected by the global regulatory authorities. Our history of global regulatory perfection is the absolute industry standard. For over 25 years, WuXi AppTec has been at the forefront of performing viral clearance studies for a wide variety of products. No one has more experience or a more highly developed program. WuXi AppTec s experts have the exceptional technical know-how to handle viral clearance studies for even the most difficult molecules, and can assist you in reaching aggressive LRV targets. Based on large-volume testing and the virus plaque assay, our scientifically-sound study designs can help reduce the number of steps needed to clear virus and dramatically increase LRVs. Our ultra-purified stocks help ensure the data generated is the most accurate assessment of your processes ability to clear or inactivate virus, and can also dramatically increase total LRV. Mining our exclusive and vast database derived from 25+ years of testing, 3500+ studies and 20,000 data points helps clients make informed decisions prior to or during critical process changes. We offer performance of continuous chromatography studies, with flexibility in client equipment selection. Also, we work with clients in R&D settings to build regulatory knowledge and evaluate integrated processes. With our commitment to continual investment to meet client demand, our expansive suite and equipment capacities allow for flexibility, ease of scheduling, quick response and fewer delays.

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