Designing your proof of concept, and predicted safety and efficacy profile alongside characterisation of your product.
GRA has expertise in multiple modalities ranging from vaccines, antibody drug conjugates (ADCs), mono-clonal antibodies (mAbs), advanced therapy medicinal products (ATMPs) to stem cell based therapies. We therefore have extensive experience to support pre-clinical, non-clinical and toxicology studies to drive drug development effectively and efficiently.
Product Design
Mode of Action
Understanding the mode of action (MoA) is foundational in preclinical development. This involves characterising how a therapeutic interacts at cellular or molecular levels. Clear insights into MoA support safety, efficacy & potency assessments, guiding the design of relevant in-vitro & in-vivo models.
Organoid Models
Organoid and 3D models offer advanced platforms to investigate drug response in human-like systems. These cell-based tools improve the relevance of efficacy & safety studies. Organoid models are increasingly used to reduce dependency on traditional models & reduce costs while preserving scientific integrity & translational value.
Safety & efficacy
Preclinical studies assess the balance between safety & efficacy using accepted methodologies. The data generated can help to identify appropriate dosing ranges & detect potential side effects. Generating reliable data at this stage supports ethical progression into clinical trials as well as building regulatory confidence.
Material & Excipient Safety
All materials & excipients used in production must be generally recognised as safe (GRAS). This includes testing for biological compatibility, purity & stability. Use of pharmacopeia materials can help to ensure suitable purity & safety, and are essential in both drug substance & drug production production in order to meet regulatory & quality expectations for product safety.
Pharmacokinetics (PK) & Pharmacodynamics (PD)
Pharmacokinectics (PK) and pharmacodynamics (PD) modelling provides insight into Absorption, Distribution, Metabolism & Excretion (ADME). PK/PD data supports dose selection & helps predict human response. These studies are key for mechanistic understanding & clinical trial design, aiding key decisions.
For more detail on how we help with all activities, click here.
Frequently Asked Questions
GLP (Good Laboratory Practice) is a quality system governing how an organisation conducts, monitors, records, reports, and archives non-clinical safety and environmental studies (as described in the UK’s GLP regulations and the FDA’s 21 CFR Part 58 guidance). It ensures that study data submitted to regulatory agencies is reliable, traceable, and repeatable.
GLP covers test facility management, study directors, study personnel, equipment, facilities, protocols, reports, SOPs, raw data, and reference materials.
- When GLP is Required: Safety-critical non-clinical studies supporting human trials—such as toxicology, genotoxicity, reproductive & developmental toxicity, carcinogenicity, local tolerance, and core safety pharmacology studies.
- When GLP is Not Required: Early exploratory research, dose-ranging studies, proof-of-concept (PoC) studies, and preliminary mechanism-of-action (MoA) or efficacy studies used for internal decision-making do not strictly require GLP, though they must still remain scientifically sound and well-documented.