QC Testing Services
We Care About Your Compliance
We Care About Your Compliance
QC Testing Services
At Svar Life Science, we take compliance seriously. Our QC team – working in our GMP-certified laboratory – is committed to providing you with quality services, in compliance with the latest regulatory requirements. We work closely with QA and R&D teams to provide you with an outstanding GMP Bioassay service to support the release, stability, and in-process testing of your drug.
Bioassays for all Steps in Drug Development
Our services cover the entire lifecycle of drug development and include method development, qualification, validation, and continuous method improvements for early and late development projects. Our scientific experts ensure high-quality bioassay design and provide guidance on development, validation, transfer, and optimization of new or existing assays.
We help you overcome the challenge of developing and implementing bioassays:
- Development of potency assays
- Validation or qualification of potency assays for QC lot release and stability testing
- Routine analysis in a GMP environment to support your GMP lot release, stability testing, and in-process testing
Our QC Testing Services Offering
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QC TESTING SERVICE
Once the assay is developed, assay validation or qualification is performed to confirm that it fits its intended purpose. Method qualification typically describes activities that demonstrate the suitability of a method for use in the early stages of drug development, while assay validation includes experiments to demonstrate that the method is reliable for long-term use in the late phases of drug development.
To meet all the specifications in the ICH and USP guidelines, we typically evaluate the performance of potency assays in terms of precision, specificity, accuracy, linearity, range, and robustness.
Assays to be qualified or validated are product-specific methods, and the scope of validation or qualification procedures depends on the phase of drug development.
Our QC Testing Services offer both qualification and validation of bioassays in a GMP-certified laboratory according to ICH and USP guidelines to ensure that the developed methods meet the performance criteria necessary for use in lot release and stability studies.
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QC TESTING SERVICE
Potency measurement is a requirement for regulatory submission and lot release testing. The assays used for GMP lot release must comply with current GMP regulations, while those used for non-clinical lot release do not require GMP compliance. Typically, the data collected from non-clinical studies can be used for planning clinical trials in humans.
Our QC Testing Services Team performs testing on:
- Non-clinical release samples
- GMP lot release samples
Our potency assay platform includes both Ligand Binding (LBA) and Cell-Based Assays, applicable to all phases of drug development. We discuss the different assay development and testing strategies to ensure that your bioassay meets the criteria requested by regulatory authorities. If an assay is in place, we start by evaluating the historical performance data.
Our team of scientific experts ensures that the chosen bioassay is robust and fit for its purpose. Moreover, we ensure that the selected bioassay is reliable and mimics your drug's intended mechanism of action (MoA).
For the GMP lot release testing, we will work with your team to establish a release specification that defines the range of acceptable potency values.
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QC TESTING SERVICE
Stability studies play a crucial role in the estimation of the shelf life of new drugs. Typically, drug products, drug substances, and placebo samples are stored under controlled environmental conditions including humidity, temperature, or exposure to light, followed by analysis at different time points. The data accumulated over time is used to determine the effects of different environmental conditions on product quality and to estimate shelf life.
Stability studies are performed during all phases of drug development, including post-licensure studies, which are used to further monitor drug stability.
Our GMP QC Services provide potency testing of stability samples to support both GMP and non-GMP stability studies. Additionally, we perform exploratory stability testing.
Our Expert QC Services team is standing by to discuss the design of your stability study and the interpretation of guidelines such as:
- Q1A(R2): Stability Testing of New Drug Substances and Products
- Q5C: Quality of Biotechnological Products – Stability Testing of Biotechnological/Biological Products.
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QC TESTING SERVICE
In-process testing is an integral part of the routine check performed during production to ensure that the established product quality is met. The analysis is performed on samples from the manufacturing process to ensure it is being manufactured to specification.
To assess drug potency in samples collected from different stages of the bioprocess, bioassays developed to support this testing are usually distinct from routine product lot-release assays since their purpose is to detect unexpected changes in the samples from the process. A drug substance or final product that fails to meet in-process or final release specifications will be rejected for use.
At Svar Life Science, we offer the following services to support your production and process development activities:
- Potency testing per your standard operating procedures (GMP or non-GMP)
- Optimization and development of potency assays
Discuss your testing strategy with our expert team
Discuss your testing needs with our QC Team to ensure that the in-process testing is performed in accordance with internationally recognized harmonized standards such as ICH and USP. Contact us using the form below.
Development of Bioassays for Potency Testing
Potency assays are quantitative measures of the biological activity of a drug product or drug substance. Within drug development and pharmacology, potency is defined as the concentration of a drug needed to produce 50% of that drug's maximal effect.
Potency tests are required for batch release and stability assessment of new biological drugs to ensure the drug's continued quality, safety, and efficacy. For this reason, biological activity is a critical quality attribute for biopharmaceuticals, and its measurement plays a crucial role in the drug approval process.
Our bioassays offering
Our offering includes both Ligand Binding Assays (LBA) and Functional Cell-Based Assays. LBAs measure the interaction between a drug and ints target, while functional cell-based assay measure the biological response triggered by the drug.
We begin our development work with a deeper understanding of the unique properties of your molecule, followed by a customized development of either LBA or Cell-Based Assays. If cell-based assays are chosen, we can offer a broad range of cell types, available as in-house products. Read about our Custom Development Services.
Our cell-based iLite® reporter-gene assays are designed to demonstrate a measurable biological response and are widely used for a reliable indication of drug activity. In general, cell-based assays are viewed as more biologically relevant than ligand-binding assays to predict the therapeutic response in a biological system.
To comply with the current regulatory requirements, we encourage the establishment of multiple potential potency assays as early as possible to ensure an accurate assessment of the drug's efficacy in the late phase of drug development.
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