Analytical Development

Our sophisticated analytical development module leverages extensive expertise in designing and implementing methodologies to characterise the drug substance and impurities, whilst ensuring process quality at every stage. All analytical methods adhere to the principles of GLP in line with Pharmacopeia standards and regulatory compliance, ensuring a seamless transition to GMP manufacturing.

Below you can read more about:

Analytical Method Development

  • Comprehensive suite of fully serviced analytical instrumentation for biologics and small molecules analysis (HPLC, GCMS, HRMS-QTOF, LCMS, AKTA, Cedex Bio®)
  • Development of validated, custom-made analytical methods for in-process analysis and product release testing
  • Broad range of complimentary analytical methods required to establish target identity, quantity, purity and potency
  • Method development including key parameters such as specificity, linearity, LOD/LOQ, accuracy, precision, recovery and robustness
  • Rigorous QC and full traceability in accordance with company QMS procedures
Man using equipment

Assay Development

  • Design, development, optimisation and qualification of new assays and/or modification of existing assays for specific targets
  • Assay development for HTS (from hit-to-lead)
  • Design and development of bespoke assays for product characterisation (drug substance and drug product)
  • Development and qualification of assays for in-process control during upstream and downstream processes
  • Development and test performance of release assay
Scientist using equipment

In-process Controls and Monitoring (IPC/IPM)

We develop IPC/IPM to monitor and ensure both process and product quality, achieving batch-to-batch reproducibility. Our comprehensive IPC/IPMs are designed to monitor critical process parameters (CPPs) essential for achieving the product's critical quality attributes (CQAs). This approach enables real-time adjustments to increase efficiency, reduce by-products and enhance product yield whilst preventing costly batch failures that can result in delays to project timelines. Detailed documentation meeting regulatory standards can be provided as required.

Our IPC/IPMs can be developed to suit your process requirements, and include:

  • Process monitoring: pH monitoring and control, dissolved oxygen (DO) levels, temperature control, agitation rate, nutrient feeding, foam control, and off-gas analysis.
  • Metabolite monitoring: tracking of feedstocks and metabolites including by-products, such as organic acids, to measure inhibitory effects on cell growth/product quality and develop control strategies.
  • Biomass monitoring: using optical density, dry cell weight, and wet cell weight measurements to assess cell growth.
  • Product concentration and yield: analysis via SDS-PAGE, Western blot, and ELISA to confirm product presence and concentration.
  • Contamination checks: routine checks to ensure microbial or cell line purity.
  • Process residual clearance: Endotoxin, host cell protein (HCP), host cell DNA (HCDNA), Nuclease and Protease levels, Mycoplasma, antibiotics, and other process residuals. Our analytical capabilities allow for non-standard residuals to be monitored.
Scientist examining tray