Non-GLP toxicology studies are fundamental in the early stages of drug discovery, providing critical data to evaluate the safety profile and potential risks of drug candidates. These studies enable researchers to identify target organ toxicity, determine dose-response relationships, and establish the Maximum Tolerated Dose (MTD) without the constraints of formal timelines. At BOC Sciences, we offer flexible and rapid non-GLP toxicology assessment services, helping pharmaceutical developers mitigate risks early, optimize lead compounds, and make informed "go/no-go" decisions with high-quality experimental data and expert scientific insights.
We utilize high-throughput cell-based assays to identify early toxic signals and prioritize lead compounds. Our services include cytotoxicity screening, mitochondrial health assessment, and membrane integrity tests across diverse cell lines. By evaluating mechanisms like oxidative stress and apoptosis in vitro, we help clients filter out high-risk molecules before progressing to animal models.
Our rapid in vivo protocols focus on Dose-Range Finding (DRF) and MTD determination. We provide flexible systemic toxicity assessments, including acute and short-term repeat-dose studies, to establish preliminary safety margins. These studies are designed to characterize dose-response relationships and systemic exposure.
We offer comprehensive evaluation of organ-specific risks through targeted toxicological endpoints. This includes pathology (hematology, chemistry), specialized biomarker analysis for nephrotoxicity or hepatotoxicity, and early histopathological screening to provide a deep understanding of potential target organ toxicity.
Early assessment of functional safety is critical for de-risking drug candidates. We screen for adverse effects on vital organ systems, including the cardiovascular (e.g., hERG inhibition), central nervous (CNS), and respiratory systems. Identifying potential functional impairments early assists researchers in refining chemical structures to minimize off-target effects.
BOC Sciences provides professional toxicology screening with reliable results and flexible options to support early-stage R&D decisions.
BOC Sciences accepts a diverse range of test articles for early safety assessment. Our toxicology platform is optimized to handle various therapeutic modalities and novel materials, ensuring reliable safety data regardless of sample complexity or formulation type.
Provide your test article specifications and study objectives, and BOC Sciences will offer expert guidance and high-quality toxicology testing tailored to your workflow.
Our toxicologists discuss your project goals to design a customized protocol, selecting the appropriate models, dose levels, and endpoints.
Compounds are administered according to the protocol. Our team performs daily observations and captures real-time data on animal health.
Collection and analysis of biofluids and tissues. We integrate hematology, biochemistry, and histopathology data for a holistic view of safety.
A detailed technical report is delivered, highlighting findings, MTD, and safety margins to guide your next phase of R&D.
We provide rapid safety profiling for small molecules and biologics during lead optimization. Our solutions focus on identifying target organ toxicity and determining MTD/DRF to establish a safety window, enabling researchers to prioritize candidates with the highest potential for success and the lowest risk of off-target effects.
Our toxicology assessments for biomaterials evaluate material-tissue interactions and systemic compatibility. We focus on screening for potential inflammatory responses, degradation-related toxicity, and tissue integration to guide the selection of safe, biocompatible materials for advanced therapeutic applications.
BOC Sciences offers specialized safety screening for novel cosmetic ingredients and formulations. We emphasize local tolerance testing, including skin and eye irritation/sensitization screening, helping clients ensure ingredient safety and support product claims during the early formula development phase.
We support early-stage medical device development by evaluating the safety of device components and surface coatings. Our screening-level assessments identify potential leachable toxicity and local site reactions, providing critical data to optimize device design and material composition before large-scale production.
Partner with BOC Sciences for precise toxicology screening of your lead compounds, biomaterials, and novel formulations. Our specialists deliver dependable results to streamline your path to the next phase.
Our streamlined Non-GLP workflows provide you with critical safety data in weeks, not months, keeping your discovery timeline on track.
We customize every protocol to meet your specific research questions, allowing for modifications mid-study to adapt to emerging data.
By focusing on essential safety signals, our Non-GLP services provide high-value insights at a fraction of the cost of full packages.
As a full-service provider, we can seamlessly link toxicology results with our medicinal chemistry and PK services for a holistic development approach.
Client Needs: A biotech company needed to prioritize three kinase inhibitor analogs by establishing their MTD and identifying potential target organ toxicity before initiating efficacy models.
Challenges: Preliminary data suggested potential hepatotoxicity, but the client lacked a clear dose-response correlation. They needed to distinguish between "on-target" efficacy and "off-target" toxicity to define a viable therapeutic window.
Solution: BOC Sciences implemented an integrated DRF (Dose Range Finding) protocol. We performed 7-day repeat dosing combined with real-time chemistry monitoring (ALT, AST, ALP, and Total Bilirubin). To enhance the data's predictive value, we integrated preliminary TK to correlate systemic exposure levels with observed histological changes in liver tissues.
Outcome: We identified a clear MTD for the lead candidate and revealed that the observed toxicity was dose-dependent and reversible. This high-resolution data allowed the client to confidently select the safest analog and set precise dose levels for subsequent proof-of-concept studies.
Client Needs: A medical research institute developed a novel biodegradable polymer for drug delivery and required a Non-GLP safety assessment regarding its systemic compatibility and degradation products.
Challenges: There were concerns that the degradation of the material might trigger localized chronic inflammation or systemic immune activation, which would compromise the carrier's performance and safety.
Solution: We designed a multi-dimensional biocompatibility screen. This included quantitative cytokine profiling (IL-1β, IL-6, TNF-α) via multiplex assays to monitor early inflammatory signals. Simultaneously, detailed histopathological evaluation of the implantation site and major filtration organs (kidneys and spleen) was conducted to assess tissue integration and material clearance pathways.
Outcome: Our analysis confirmed the material's excellent local tolerance and established a safe degradation profile. The client used these findings to optimize the polymer's molecular weight, ensuring a controlled degradation rate that aligns with the therapeutic release schedule.
Client Needs: A cosmetic developer sought rapid safety screening for several novel botanical extracts intended for high-end skincare formulations to ensure no skin or eye irritation.
Challenges: The client faced tight product launch timelines and required a "cruelty-free" approach, preferring data derived from validated alternative models before any confirmatory in vivo assessments.
Solution: BOC Sciences employed a tiered screening strategy. First, we utilized Reconstructed Human Epidermis (RhE) models to assess skin irritation and corrosion scores. This was followed by BCOP (Bovine Corneal Opacity and Permeability) assays to predict ocular irritation potential. This tiered approach replaced traditional high-volume animal testing while maintaining high predictive accuracy for human skin responses.
Outcome: The client received a comprehensive safety profile for all extracts within 14 days. This allowed them to eliminate two irritant-prone candidates early, significantly accelerating the final formulation of their non-irritating, consumer-ready product line.
Non-GLP toxicology studies are typically applied in early drug or chemical development to rapidly assess the safety profile of candidates. BOC Sciences provides flexible study designs tailored to dosage ranges, administration routes, and animal models, ensuring scientifically valuable results that support subsequent optimization and decision-making.
BOC Sciences’ expert team designs Non-GLP study protocols based on project characteristics, including dose gradients, administration frequency, and observation endpoints. Close collaboration ensures the design meets scientific evaluation needs while optimizing resource efficiency, generating data useful for potential GLP studies or R&D strategy planning.
Non-GLP toxicology studies generate multi-dimensional data such as body weight changes, hematology, biochemistry, and organ pathology. BOC Sciences provides comprehensive data organization and statistical analysis, delivering clear results that support scientific evaluation of candidate safety and guide subsequent R&D adjustments.
Species responses to chemicals can vary significantly. BOC Sciences offers diverse standard animal models and experienced teams to recommend the most suitable model based on the candidate’s characteristics and study objectives, ensuring reliable toxicology results while optimizing experimental resource use.
BOC Sciences not only provides Non-GLP toxicology experiments but also offers data interpretation and R&D strategy advice. Our experts can propose optimization strategies based on results, assisting clients in candidate selection, dose adjustment, and safety evaluation to enhance overall R&D efficiency and scientific rigor.
The rapid MTD and DRF data provided by BOC Sciences were instrumental in our lead optimization phase. Their ability to deliver high-quality toxicology profiles in a non-GLP setting allowed us to select the safest candidate weeks ahead of schedule.
— Dr. James, Principal Scientist, Oncology Biotech
We were impressed by the flexibility of their toxicologists in designing a customized repeat-dose study for our novel ADC. Their integration of cytokine monitoring provided a clear understanding of off-target risks.
— Dr. Sophia, Head of Early Safety, Global Pharmaceutical Firm
The correlation between systemic exposure and organ-specific findings helped us define a clear therapeutic window, giving our team the confidence needed to move our program into the next phase.
— Dr. Michael, VP of Drug Discovery, Specialty Biopharma
Their technical support team was highly responsive, helping us interpret complex genetic toxicology results and refine our formulation strategy early in the R&D cycle.
— Dr. Elena, Senior Research Director, Innovative Therapeutics
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