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AIT Bioscience

Indianapolis, Indiana, US

AIT Bioscience provides expert bioanalytical assay services for small molecule and biotherapeutic drug programs from early discovery to IND enabling toxicology through clinical studies to NDA/ANDA/BLA filing.

Our processes & systems were designed from the ground up by veteran industry experts who thought it was time to approach bioanalytical processes differently. With years of experience in quantitative bioanalysis and drug development support for small biotech and large pharmaceutical companies, our scientific team spent months evaluating the issues that plague current CROs in order to identify a more efficient way to conduct business in a regulatory setting. Our “greenfield” solution: a paperless environment that assures correctness from one step to the next.

Instead of addressing issues uncovered in data review after the fact, AIT Bioscience employs novel electronic systems that detect and resolve... Show more »

AIT Bioscience provides expert bioanalytical assay services for small molecule and biotherapeutic drug programs from early discovery to IND enabling toxicology through clinical studies to NDA/ANDA/BLA filing.

Our processes & systems were designed from the ground up by veteran industry experts who thought it was time to approach bioanalytical processes differently. With years of experience in quantitative bioanalysis and drug development support for small biotech and large pharmaceutical companies, our scientific team spent months evaluating the issues that plague current CROs in order to identify a more efficient way to conduct business in a regulatory setting. Our “greenfield” solution: a paperless environment that assures correctness from one step to the next.

Instead of addressing issues uncovered in data review after the fact, AIT Bioscience employs novel electronic systems that detect and resolve potential deviations and errors in real time. Plus, you will be able to closely monitor our laboratory’s progress on your project, allowing you to manage your project with greater efficiency.

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Multiplex PK Assays
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MSD Assays
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AITB's MSD Platform is one of our go-to instruments for sensitive PK assays, Immunogenicity (Anti-Drug Antibody), and multiplex biomarker assays. It is fully integrated into our Electronic Lab Notebook quality system and Watson LIMS for ease of data integration and data review. AITB can support de-novo assay development, or... Show more »

AITB's MSD Platform is one of our go-to instruments for sensitive PK assays, Immunogenicity (Anti-Drug Antibody), and multiplex biomarker assays. It is fully integrated into our Electronic Lab Notebook quality system and Watson LIMS for ease of data integration and data review. AITB can support de-novo assay development, or an transfer of a sponsor's assay. This includes AITB's ability to reliably prepare the appropriate conjugated reagents required for MSD analysis.

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Mesoscale Discovery Sector S 600
Ligand Binding Assays
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At AIT Bioscience our Ligand Binding Assay team is both highly experienced and equipped technically
to meet the bioanalytical challenges presented by today’s diverse array of biotherapeutics. AIT Bioscience has redesigned how a bioanalytical lab should operate; this has allowed us to develop a paperfree Electronic Lab Notebook... Show more »

At AIT Bioscience our Ligand Binding Assay team is both highly experienced and equipped technically
to meet the bioanalytical challenges presented by today’s diverse array of biotherapeutics. AIT Bioscience has redesigned how a bioanalytical lab should operate; this has allowed us to develop a paperfree Electronic Lab Notebook (ELN) environment where LBA data are captured electronically into Watson LIMS. What this means is your quality reviewed data and reports are generated more quickly to enable you to make informed decisions sooner. The ELN provides complete trace-ability and transparency for all study data inputs. With PhD scientists and experienced CRO professionals at the core of our Ligand Binding Assay team, AIT Bioscience uses our expertise and innovation to provide you with valuable PK/TK, PD and immunogenicity information to support your pre-clinical and clinical studies. Experience the benefits of working with a technically-
advanced and truly innovative LBA team of professionals.

Ligand Binding Assay Services
• PK, Biomarker, Anti-Drug Antibody (ADA), and neutralizing antibody
• Method transfer and optimization
• Method development, fit-for-purpose qualification, and full validation
• Rapid sample analysis of preclinical and clinical studies
• Tiered Approach to Anti-Drug Antibody sample analysis (Tier 1 Screening, Tier 2 Confirmation, and Tier 3 Titer)
• Instrument platforms includes MSD, ELISA, RIA, and Gyros
• Neutralizing antibody assay (both cell and plate based)

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Oncology
Obesity & Diabetes
Fluorescent labeling
CNS/Neurology
ELISA
RIA
Neuropathic Pain
Diabetes
dermatology
Oncology
Immunooncology
Immunooncology
Cell-based assays
Ophthalmology
LC-MS/MS
Liquid chromatography tandem mass spectrometry
Price on request

Our LC-MS/MS assay development team averages > 18 yrs industry experience. We combine this deep scientific knowledge with the 'will to win' to solve the most challenging assay issues. Average assay development projects are 5 business days for most small molecule programs. Protein Mass Spec programs take longer due to... Show more »

Our LC-MS/MS assay development team averages > 18 yrs industry experience. We combine this deep scientific knowledge with the 'will to win' to solve the most challenging assay issues. Average assay development projects are 5 business days for most small molecule programs. Protein Mass Spec programs take longer due to the complexity of the projects.
We use a tiered approach to support assays from discovery to preclinical then validate the assays support IND enabling Tox and clinical studies. Our experience includes prodrugs, chiral compounds, peptides, derivatization chemistries, low molecular weight compounds, and other unique drug candidates. Beyond plasma & urine, we have extensive experience in tissue analysis, which applies to CNS, ocular, dermal, and animal health (veterinary drugs) programs. Typical lab turn around times for small molecule LC-MS/MS validations are 2 weeks for lab work and another week for draft report.

AIT Bioscience LC-MS/MS Capabilities
• Non-GLP discovery analyses — getting good results fast, for internal use
• Method development — whether you just have powder or a basic method, we can work out the kinks
• Method transfer of sponsor methods — We recognize the challenge of transferring a method and work closely with you to transfer your method to our lab, and optimize if required, regardless of LC-MS platform.
• Method validation consistent with EMEA and FDA guidances
• Fit for purpose assay qualification to balance budgets, timelines, and data submission needs
• High-throughput discovery, preclinical, and clinical sample analyses (5 business day preclinical, 10 business days clinical, expedited processing is available)
• Variety of species and matrix experience
• Microflow LC to facilitate more sensitive assays for both small molecules and biotherapeutics

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Biomarker Assay Development
Price on request

Biomarkers have numerous uses: as diagnostic indicators of disease, indicators of biological pathways for new therapeutics, for efficacy and safety determinations, and as phamacodynamic (PD) measures of therapeutics pharmacokinetic (PK) profile. The use of biomarkers can usher in a new era of predictive, preventative, and... Show more »

Biomarkers have numerous uses: as diagnostic indicators of disease, indicators of biological pathways for new therapeutics, for efficacy and safety determinations, and as phamacodynamic (PD) measures of therapeutics pharmacokinetic (PK) profile. The use of biomarkers can usher in a new era of predictive, preventative, and personalized medicine, where therapeutics can be tailored to a patient’s unique biology.

Because of the diversity of biomarker applications for drug development and diagnostics, regulatory requirements are not well defined. For the purpose of biomarker applications, the pharmaceutical industry has adapted a “Fit-for-Purpose” philosophy where the rigor of validation is defined by the intended use of the data.

Biomarker Services
• Fit-for-purpose method qualification and/or validation
• Discovery, preclinical, and clinical biomarker analyses
• Single analyte or multiple analyte measurement capabilities
• Multiple platforms including MSD, ELISA, and Gyros
• LC-MS/MS biomarker capabilities

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Cell-Based Assays
Price on request

AITB has invested in the equipment as well as the skilled personnel needed to successfully execute your cell-based assay needs. Our equipment includes the Beckman Vi-Cell analyzer, redundant incubators, and cell line storage capabilities (LN vapor phase). Additionally, we routinely assess cell lines for mycoplasma contamination... Show more »

AITB has invested in the equipment as well as the skilled personnel needed to successfully execute your cell-based assay needs. Our equipment includes the Beckman Vi-Cell analyzer, redundant incubators, and cell line storage capabilities (LN vapor phase). Additionally, we routinely assess cell lines for mycoplasma contamination to ensure clean working cell lines for use in the method. We are able to use several different detection systems in the cell-based assay including luminescence, fluorescence, absorbance, and even electrochemiluminescence.

The analysts and scientists at AITB have experience in a number of cell-based assay methodologies. We have experience developing and validating numerous cell-based neutralizing antibody assays for use in the clinic, receptor binding studies, and even developing cell-based validatable quantitative ligand binding assays to measure pharmacokinetics. Allow our experience and knowledge in the ways cells can be used as reagents and tools help you address any bioanalytical needs and questions you may have.

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In vitro Immunogenicity Assays
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With an increase in biopharmaceutical products in development, including antibodies and therapeutic proteins, the need for a robust immunogenicity assay is critical to assess the safety and efficacy of these therapeutics. The dosing of biotherapeutics can often elicit an immune response, in the form of anti-drug antibodies. The... Show more »

With an increase in biopharmaceutical products in development, including antibodies and therapeutic proteins, the need for a robust immunogenicity assay is critical to assess the safety and efficacy of these therapeutics. The dosing of biotherapeutics can often elicit an immune response, in the form of anti-drug antibodies. The potential for these therapeutics to develop an immune response is dependent on several factors: the nature of the drug (degree of foreignness, aggregation, purity, formulation), nature of the dose (route of administration, chronic vs. acute dosing, PK), and nature of the patient (immunosuppression, autoimmune diseases).

The development and validation of methods for detection of host anti-drug antibodies are required by the US FDA and other regulatory authorities. At AIT Bioscience we have developed our processes for immunogenicity evaluation based upon the FDA Draft Guidance for Assay Development for Immunogenicity Testing of Therapeutic Proteins (2009) and several other industry standard reviews. The detection of anti-drug antibodies is dependent on key elements including sensitivity, interference, functional/physiological consequences, and a risk-based application. There are multiple analytical approaches which may be appropriate for immunogenicity testing during pre-clinical and clinical trials. We use a three-tiered approach, where sample analysis begins with an anti-drug antibody screening step that will identify potentially positive samples. Potentially positive samples are tested further by using a confirmatory procedure (e.g. competition-based method) in which samples are pre-incubated in the presence and absence of excess drug to demonstrate specificity of the assay response. If sufficient inhibition is found to confirm a true positive, the positive samples will undergo a titration procedure to assign a quasi-quantitative value as the titer.

Anti-Drug Antibody (ADA) Assays
• Tiered approach to ADA detection and characterization
• Domain specificity
• Antibody isotype identification

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NAb Assays
Neutralizing Antibody Assays
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The analysts and scientists at AITB have experience in a number of cell based assay methodologies. We have developed and validated multiple cell based neutralizing antibody assays for use in the clinic, experience with receptor binding studies, and have even worked with cells to develop validatable quantitative ligand binding... Show more »

The analysts and scientists at AITB have experience in a number of cell based assay methodologies. We have developed and validated multiple cell based neutralizing antibody assays for use in the clinic, experience with receptor binding studies, and have even worked with cells to develop validatable quantitative ligand binding assays to measure pharmacokinetics. Allow our diverse experience and knowledge in the ways cells can be used as reagents and tools in the LBA lab to help you address any bioanalytical needs and questions you may have.

Since the administration of biotherapeutics can elicit generation of unwanted antibodies that can alter pharmacokinetics and/or block the desired pharmacological efficacy, it’s often important to test for the presence of circulating neutralizing anti-drug antibodies (NAb). Once an ADA response has been identified, an in vitro cell-based assay is often employed to characterize the ADA response to understand whether they are neutralizing. Cell-based assays are generally regarded to be superior and more reliable to verify if antibodies
are potentially neutralizing. At AITB we apply our in-depth knowledge in bioanalysis, experience in technical innovation, and understanding of statistical-thinking to provide clients with robust NAb assays.

Neutralizing Antibody Assays
• Cell based and LBA based capabilities
• Multi-domain therapeutics (dual cell line validation) experience

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Preclinical PK/PD Studies
in vivo Pharmacokinetics/Pharmacodynamics
Price on request

The successful development and commercialization of today’s biotechnology and conventional drugs requires the careful execution and analysis of a series of Clinical Pharmacology studies. Data from such investigations take a prominent place in product labeling, provide an underpinning for the mechanism of action, define... Show more »

The successful development and commercialization of today’s biotechnology and conventional drugs requires the careful execution and analysis of a series of Clinical Pharmacology studies. Data from such investigations take a prominent place in product labeling, provide an underpinning for the mechanism of action, define exposure-response relationships, and establish dosing requirements in different populations. At the heart of Clinical Pharmacology studies are robust bioanalytical measurements of the drug substance and the application of state-of-the-art pharmacokinetic or pharmacodynamic analyses using specific models to assess and summarize the important findings. We will help you design and carry out your research in such a way as to help you to develop an optimal plan of implementation.

In addition to supporting the pharmacokinetic analysis of small molecules, the analysis of large molecule therapeutics presents unique challenges. Ligand-binding assays are typically employed due to the specificity of capture and detection antibodies for the analyte as well as the sensitivity that can be achieved over LC-MS/MS assays. AIT Bioscience can support your TK/PK study from discovery phase through clinical trials. Our processes are modeled after industry standard white papers with acceptance criteria specifically for ligand-binding assays.

Clinical Pharmacology, Pharmacokinetics, and Modeling Services include
• Designing Clinical Pharmacology Studies to Support Development and Commercialization
• Assessing Requirements for Sampling and the Number of Subjects
• Planning PK/PD Analyses and Outlining the Scope of PK/PD Assessments for Specific Studies
• Evaluating PK/PD Data Using Non-Compartmental Models
• Modeling Concentration-Time-Response Relationships Using Compartmental and Effect Models
• Interpreting PK/PD Results and Providing Strategic Decision Support for Projects
• Reporting PK/PD Results in QA/QC’ed Reports
• Assisting Clients with PK/PD Regulatory Interactions and Engagement

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Biology
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Functional & Cell Type Specific Assays
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Immune Cell Assays
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Biochemistry & Molecular Biology
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Protein Services
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Protein Quantification
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Biomolecular Interaction Analysis
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Imaging & Spectroscopy
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Spectroscopy
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Mass Spectrometry
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Liquid Chromatography Coupled Mass Spectrometry Methods
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Pharmacology & Toxicology
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Immunoassays
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Bioanalysis
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Biomarkers
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Drug Discovery & Development
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Drug Discovery & Development Services

Drug Discovery & Development Services

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Pharmacology
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Pharmacology Services

Pharmacology Services

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