Reference Standard Characterization and Management

Our testing capabilities cover the full spectrum of pharmaceutical reference materials, from small molecule drugs to complex biologics. We specialize in developing and characterizing non-compendial reference standards when commercial options aren't available, supporting proprietary compounds, generic drug applications, and extractables and leachables studies. When high purity compendial reference standards (>99.5%) aren't available, we develop custom solutions that meet FDA requirements and rigorous quality standards. 

Our comprehensive analytical suite delivers complete structural and purity verification through advanced techniques including 1D/2D NMR, LC-MS, FT-IR, UV Spectroscopy, and specialized biologics characterization methods. We support potency testing through ELISA, enzymatic activity assays, and in-vitro cellular assays.

We provide end-to-end reference standard support including synthesis, scale-up, characterization, and qualification. Our GMP-compliant storage and distribution services free you from logistics concerns, while our annual requalification programs maintain your standards' integrity. Our solutions help assess manufacturing process changes impact on drug products and overcome development challenges. When thorough and rigorous characterization is carried out early in drug development, the investment pays dividends as your product progresses to later stages, resulting in significantly improved final product quality. Virtual pharmaceutical companies particularly benefit from our complete storage and distribution capabilities. 

Non-compendial reference standard development services: 

Creating non-compendial reference standards requires specialized knowledge and resources. Element’s team of experienced scientists is skilled in synthesizing, characterizing, and qualifying these standards, especially when compendial standards aren’t available, such as in proprietary compounds, generic drug applications, or extractables and leachables studies. 

Reference standard requalification, storage and distribution: 

Element offers reference standards requalification, storage and distribution services, which are particularly helpful for virtual pharmaceutical companies that lack the resources to store reference materials. We follow GMP procedures for managing reference standards, ensuring proper storage conditions, timely requalification, and secure shipment. 

Biologics and biosimilars reference standard characterization: 

Biopharmaceuticals have more complex structures than small-molecule drugs, making complete characterization difficult. As a result, a range of analytical tests, like cell-based potency and chromatographic assays, are commonly used to assess the quality of active ingredients and drug products. These tests help with characterization, comparability, lot release, and stability confirmation. Reference standards are essential for calibrating these tests, ensuring they’re suitable, and establishing a benchmark by defining the physicochemical profile of a biologic or biosimilar product. 

Reference standard management program services: 

• Synthesis and scale-up of unique and/or proprietary reference standards 

• Reference standard characterization for both structure and purity 

• Periodic requalification 

• Reference standard storage and distribution 

Pharmaceutical reference standard chemical identity and structure validation techniques: 

• 1-D and 2-D NMR: Proof-of-structure in which 1H and 13C NMR resonances are assigned and connectivities along rings and chains are demonstrated 

• LC-MS: identification of the molecular mass of a standard 

• FT-IR and UV Spectroscopy: Demonstrates consistency with putative structure 

• DSC: Demonstrate consistency with reported melting point and known thermal characteristics 

Pharmaceutical reference standard purity assessment methods: 

• HPLC: Calculates an area-under-the-curve purity, which is corrected for water by Karl Fischer titration 

• ICP-MS: Detects the presence of heavy metals 

• TGA: Detects residual solvents 

Large molecule reference standard characterization services: 

• Identity: Peptide mapping, western blot, Post-translational modification (PTM) analysis 

• Purity: U/HPLC, CE-SDS, SDS-PAGE, Charge heterogeneity by CIEF 

• Potency:(ELISA, enzymatic activity assay, in-vitro cellular assays 

• Physicochemical characteristics: Appearance, pH, osmolality, moisture content 

• Impurities: including residual process impurities 

• Biosimilar characterization programs: Amino acid sequence, Biocomparability 

• Method development: Analytical method development, validation and transfer
• Structure analysis: Evaluation of binding affinities, Aggregation by DLS and SEC 

Advanced analytical instruments support structure validation and purity assessment: 

•  NMR and MS spectrometers for molecular characterization 
• HPLC systems for purity determination 

• Specialized equipment for biologics testing including DLS and SEC 

• Thermal analysis instruments including DSC and TGA 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.