Accelerate Confident Biologic Development With Proven In Vivo Potency Expertise
Charles River Laboratories provides comprehensive bioassay method development, optimization, transfer, and ICH-compliant validation to support the full lifecycle of biologics, vaccines, and biosimilars. With decades of scientific experience, our team delivers robust, regulatory ready bioassays that meet global expectations for accuracy, reproducibility, and data integrity.
Unlocking Vaccine Potency: Bridging In Vivo, In Vitro, and Emerging Modalities
Navigate modern vaccine potency testing to cut risk, meet global regulations, and accelerate development, facilitating faster market entry and protecting public health effectively.
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Bioassays — especially in vivo potency assays — play a critical role in demonstrating the biological activity, efficacy, and functionality of advanced therapeutics. Our scientists bring deep expertise and GMP-compliant capabilities to support your preclinical, clinical, or post-marketing programs efficiently and confidently.
Potency is a critical quality attribute (CQA) for controlling the quality, consistency, and relevant properties of biologics, including a physiologically relevant response. In vivo potency assays remain the definitive measure of therapeutic activity. We specialize in developing, qualifying, and executing these critical studies, including:
- Hormone potency assays (FSH, LH, eCG, hCG, EP/USP compliant): qualified technicians and extensive track record of expertise in assay execution, including the critical necropsy procedures; our experts can support dose ranging and dose qualification activities for hormone-based products
- Diphtheria antitoxin potency assay: validated test system in the guinea pig model to GMP standard
- Vaccine immunopotency: long track record in rodent models (mice, rats, hamsters, guinea pigs) as well as rabbit and ferret models; expertise in various routes of drug administration (intramuscular, intravenous, intradermal, intraperitoneal, intranasal, intracranial and subcutaneous)
We also offer specialized capabilities in vaccine immunogenicity studies (such as Japanese Encephalitis, Varicella-Zoster, Meningococcus Diphtheria, and Tetanus); influenza studies, including challenge studies conducted in the mouse and ferret model and under BSL2 or BSL-3 conditions; SARS-CoV-2 challenge studies in LGV hamster model and other sub-lethal challenge studies for drug and vaccine efficacy. Many assays can be performed in accordance with EP, USP, BP, or JP guidelines. Our experts can help you navigate regulatory requirements and GMP compliance, ensuring global regulatory compatibility.
Beyond our in vivo bioassay development, optimization, transfer, and validation services, we integrate within a broader biologics testing ecosystem and support end-to-end quality control testing — in vivo biosafety for viral and bacterial agents (BCG products) as well as release testing, stability, and cell bank/seed characterization — delivered through a global facility network to harmonize quality systems and timelines.
From early feasibility through validation, we guide your in vivo potency strategy with scientific precision. Our team supports:
- Rangefinding studies to determine optimal dose levels and method range
- Assay development, optimization, and validation
- Implementation and execution for routine potency testing
Whether your goal is to demonstrate biological activity, verify product efficacy, or support regulatory submissions, our in vivo bioassays deliver quality, decision-enabling data.
Accelerate Vaccine Testing
As regulatory authorities increasingly adopt advanced analytical technologies, Next Generation Sequencing (NGS) is emerging as a powerful tool for vaccine quality control. NGS provides a fast, comprehensive alternative to historical viral safety assays—offering deeper detection capabilities, faster turnaround times, and streamlined support for clinical and commercial release. This enables developers to move more quickly from vaccine manufacturing to market with confidence in the safety and consistency of their product.
Next Level Viral Safety Testing
Biologics are vulnerable to viral contamination, posing risks to patient safety. This whitepaper discusses traditional detection methods and their limitations, and demonstrates how validated NGS technology can enhance viral safety testing, reducing risk and expediting market access.
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Regulatory for In Vivo Bioassay Validation
Our bioassay development and validation approach is fully aligned with FDA, EMA, and ICH guidelines and expectations, ensuring your data package meets stringent global standards. Regulatory authorities emphasize that:
- Potency assays must reflect the mechanism of action, be quantitative, reproducible, stability-indicating, and biologically relevant.
- Animal-based assays may be required when in vitro assays cannot replicate or translate complex physiological responses.
- Validation must address specificity, sensitivity, precision, linearity, and robustness per ICH Q2(R2).
For complex biologics, in vivo assays often complement in vitro methods to satisfy orthogonal testing requirements and ensure comprehensive product characterization. We support in vivo testing with ex vivo readouts based on current in vitro technologies.
Whether you're preparing for IND, scaling potency assays for clinical supply, or validating methods for commercial release, Charles River delivers the scientific rigor and regulatory alignment needed to advance your biologics.