As a pharmaceutical manufacturer, you have a responsibility to ensure product quality, safety, and regulatory compliance. There must be clarity at each stage of development, and confidence that every analytical method is understood, and controlled. Analytical blind spots can affect development timelines, therapeutic efficacy, and risk regulatory rejection.

The Eurofins BioPharma Product Testing network of laboratories provides an integrated approach to analytical development and physicochemical characterisation. We do not deem these pillars as separate tasks; they are interdependent processes that must be aligned from early-stage development through to commercialisation. This integrated strategy ensures your product’s identity, purity, potency, and performance are consistently defined and controlled. This is vital for regulatory approval, but also for efficient scale-up, effective lifecycle management, and reduced risk.

Analytical development

You must establish validated, reliable methods to:

• Confirm API identity and assay using techniques like HPLC, GC, and spectroscopy
• Detect and quantify impurities and degradation products
• Monitor stability under ICH conditions
• Support dissolution and release testing
• Ensure method robustness and transferability across sites and phases

Physicochemical characterisation

Simultaneously, you must characterise the physical and chemical properties that influence formulation, manufacturability, and performance:

• Solubility, pKa, and Log P to guide formulation design
• Polymorphism and crystallinity to ensure batch-to-batch consistency
• Particle size, morphology, and surface area to control dissolution and bioavailability
• Hygroscopicity and thermal behavior to inform packaging and storage

By integrating analytical development with comprehensive characterisation, we help you define a fully informed product profile. You gain a complete understanding of your product’s critical quality attributes (CQAs). This enables you to make informed decisions around formulation and process design, accelerate development timelines, minimise regulatory risk, and safeguard both patient safety and therapeutic efficacy.