Lab Services
LAB SERVICES
As part of the IPAR ISPC methods provider, Relvit Center Lab is involved in all aspects of the selection, safety, and substantiation phases. We can fully support the unique demands of both nutraceutical and dietary supplement analysis.
Relvit understands the complexities of this industry and can deliver the rigorous analytical services needed to create safe, high-quality products that meet industry standards. With more rigorous testing, our clients can provide higher quality products to their customers, thereby standing out from their competition.
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Relvit’s Cell-Based Bioassay Capabilities
Relvit can skillfully incorporate cellular assays into your drug development program, adapting to your project needs. With years of cell and tissue culture experience and a dedicated BSL 2 facility, our team can work with any cell type in both monolayer and suspension formats, including different immortalized cell lines (such as MDCK, CHO, HEK293, and more), primary cells, and tissue samples (such as brain, blood, milk, and more).
Our scientists support clients at all stages of their drug development program from discovery, preclinical research, and clinical trials, all the way to commercial manufacturing and post-market surveillance. In particular, we place special importance on our ability to help our clients confidently navigate regulatory filings and approval processes. To support our client’s CMC activities, we offer a complete suite of CMC testing services, including in vitro potency testing, in vitro cellular uptake, MTS assays, permeability studies, and large molecule characterization, as well as IND/BLA submission support and regulatory consulting.
We know firsthand that CMC activities are not the same for every biologic drug candidate. That’s why our scientists are adept at rapidly executing custom cell-based bioassay development and validation, in addition to other more routine cellular assays. These custom assays accurately and robustly assess your biologic drug, regardless of modality, mechanism of action, and drug target. Importantly, our method development and biological assay validation services are always built to be stage appropriate.
Our Bioassay Capabilities Include:
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Potency assays: custom bioassay development and validation per ICH guidance, including:
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Biologic drug cellular uptake
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Cellular response to a biologic drug
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Bioassay method optimization
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Drug permeability assays
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Cell proliferation and viability determination (MTT/MTS assays)
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Cytokine screens
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Reporter gene assays by fluorescence
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Gene expression analysis
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Cell signaling assays
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Ligand binding assays
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Cell death & apoptosis testing
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In vitro cytotoxicity studies
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Drug target identification & isolation from tissue samples
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Biologic drug characterization
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Basic research and drug discovery
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BLA submission support
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Routine lot testing
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Potency testing within a stability assessment
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Cell banking
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Media qualification and characterization
Alongside our cell culture and biologic drug development skillsets, Relvit has repeatedly shown the ability to collaborate effectively with teams across a diverse spectrum of biopharma organizations. Having worked with everyone from small virtual drug discovery groups to large biopharma companies, we understand the challenges you’re facing and can help. Whether you lack in-house biological expertise and specialized equipment, or simply don’t have the capacity to execute your own bioassay plan with your current resources, Relvit can support your biologic program with tailor-made bioassay services and experienced regulatory consulting.
COVID-19 Diagnostic Test Development Laboratory
Researchers pursuing the next generation of COVID-19 diagnostics can benefit from Relvit’s deep bench of viral and immunological diagnostic expertise. Throughout the pandemic, we have leveraged our long-standing experience in this space to develop a number of COVID-19 diagnostics for various partners. Our purpose-built labs and Ph.D.-led scientific teams stand ready to act as an extension of your team and facility. Additionally, our consultative experts can also provide significant know-how around the changing regulatory landscape and agency guidelines.
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A dedicated, consultative team of scientists with a deep understanding of viral and immunological diagnostic test development
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Regulatory knowledge and experience needed to support EUA applications with data and documentation
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Flexible and customized co-development partnership arrangements and structures to share in the cost of COVID-19 testing platforms
Tests where authorization would increase testing accessibility, like
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Point-of-care (POC) tests
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Home collection tests
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At-home tests
Tests that would significantly increase testing capacity, like
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Tests that reduce reliance on test supplies
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High-throughput, widely distributed tests
SARS-CoV-2 Testing & Diagnostic Co-Development Opportunities
Relvit is committed to standing alongside our clients and partners in the fight against COVID-19. As part of this commitment, Relvit has active co-development projects underway with our partners. If you’re looking for a co-development partner who may share in the cost of your next generation COVID-19 testing platform, connect with us to discuss options for potential co-development arrangements. We are steadfast in our support of clients and partners as they develop solutions to meet public health needs during this unprecedented time. If you have a partnership agreement in mind, we want to hear from you. If not, we will propose our ideas once we talk more.
Molecular Diagnostic Tests
Molecular diagnostic tests have played a central role in pandemic control strategies, since they can determine if an individual has an active infection, quantify viral load, and indicate when individuals have fully cleared the virus post-recovery. Typically, molecular tests (e.g. Nucleic Acid Amplification Tests or NAATs, such as RT-PCR or droplet digital PCR) detect SARS-CoV-2 RNA in nasopharyngeal secretions and saliva to diagnose infection. These tests are highly sensitive and are able to detect both early and asymptomatic infections.
Among our history of molecular diagnostic projects, Relvit has significant experience helping local public health organizations develop their own molecular diagnostic tests that detect and quantify SARS-CoV-2 variants. In addition to molecular diagnostic development service experience, Relvit has been performing PCR-based COVID-19 tests for many months of the pandemic. This hands-on test execution further helps us understand the key considerations for designing optimal tests.
Antigen Diagnostic Tests
Antigen tests detect one or more specific proteins (i.e. antigens) from viral particles. Most currently authorized antigen tests can be used in point-of-care (POC) formats to provide answers fast—with results in as little as 15 minutes. Although antigen tests are highly specific, they tend to be less sensitive than molecular tests. However, antigen tests have the capability to scale to test millions of individuals daily due to their relatively low cost of production, easy-to-use format, and rapid turnaround time compared to molecular tests. Antigen tests also offer advantages in terms of greater flexibility when it comes to the handling and transport of specimens. For these reasons, they are often used to diagnose active COVID-19 infections as well as in time sensitive cases or when molecular tests are not possible.
Serology & Antibody Tests
Molecular diagnostic tests have played a central role in pandemic control strategies, since they can determine if an individual has an active infection, quantify viral load, and indicate when individuals have fully cleared the virus post-recovery. Typically, molecular tests (e.g. Nucleic Acid Amplification Tests or NAATs, such as RT-PCR or droplet digital PCR) detect SARS-CoV-2 RNA in nasopharyngeal secretions and saliva to diagnose infection. These tests are highly sensitive and are able to detect both early and asymptomatic infections.
Among our history of molecular diagnostic projects, Relvit has significant experience helping local public health organizations develop their own molecular diagnostic tests that detect and quantify SARS-CoV-2 variants. In addition to molecular diagnostic development service experience, Relvit has been performing PCR-based COVID-19 tests for many months of the pandemic. This hands-on test execution further helps us understand the key considerations for designing optimal tests.
Pharmaceutical Testing
We work with our partners to build comprehensive programs that incorporate the assays, methods, and instruments that will best help them to reach their goals. This may include:
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Biologics Analysis
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Therapeutic Protein Characterization
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Monoclonal Antibody Characterization
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Gene Therapy Analytical Testing
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Cell Culture & Bioassay Services
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Biomarkers & Bioanalytics
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Bioanalysis & Clinical Biomarker Services
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Toxicity & Clearance Assays
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Chemistry, Manufacturing & Controls (CMC)
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Comprehensive CMC Program Support
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Extractables & Leachables
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Compendial Testing
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Release Testing
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Stability Testing
Pharmaceutical Formulation & Process Development
Our experts have in-depth knowledge of active pharmaceutical ingredients, excipients and delivery methods, as well as the expertise to anticipate and avoid potential interactions in biopharmaceuticals and therapeutics.
Relvit provides support for an extensive variety of pharmaceuticals, devices, and supplements, including:
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Solid & oral medications (tablets & capsules)
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Emulsions
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Microspheres
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Over-the-counter (OTC) medications
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Cosmeceuticals
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Generics
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Implants
From formulation development to Chemistry, Manufacturing, and Controls (CMC) guidance and post-approval support, our team will be your scientists, regulatory experts, and consultants.
Thorough physiochemical characterization of drug substances is essential to achieving optimal formulation and robust dosage forms. The chemists and scientists at our laboratories have the technical capability and hands-on experience necessary for:
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API and excipient characterization for small and large molecules
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Faster development of optimal dosage forms
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Continued support for formulations as they undergo standard testing
We customize our approach at any stage of biopharmaceutical development whether it’s modifying a formulation or developing a comprehensive development program across your drug product portfolio.
Formulation & GMP Manufacturing Services
A thorough physicochemical characterization of drug substances is essential to achieve a good formulation and a strong dosage form design.
Our pre-formulation team will deliver you a plan that will provide a reliable formulation underpinning and accelerate your drug product’s path to the clinic.
If you’re looking for a reliable third-party laboratory to develop a pre-formulation process, Relvit is your solution. We provide pharmaceutical pre-formulation studies, API characterization, dosage form design, and all the components you need to accelerate your drug development.
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Raw Material Sourcing
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Salt Screening & Selection
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Particle Size Morphology Analysis
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Polymorph Screening
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Distribution Coefficients
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Moisture Content
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Solubility Profile
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Aqueous
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pH
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Organic
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Excipient Selection
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Stability of API
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Heat
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Light
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Oxidative stress
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pH
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Structure Characterization
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Dissociation Constants
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Hygroscopicity & Lipophilicity
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Surface Tension
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Powder Flow Testing
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Polymorphism Studies
Nutritional Supplement Testing Services
Key ingredients assays
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Heavy metal impurity detection
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Moisture analysis
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Shelf-life testing
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Raw materials testing and identification
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USP/NF certification
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Lot testing/release
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Label claim verification
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Adherence to retailer standards (including Amazon Dietary Supplement Analysis)
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Formulation and product development
Nutraceutical Product Testing Services:
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Biomarker assays of active ingredients
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Heavy metal impurity detection
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Pesticide and herbicide screening
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Shelf-life testing
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Raw materials testing and identification
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Certification to industry standards
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Label claim verification
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Formulation and product development