Pharmaceutical & Biotechnology

In pharmaceutical discovery and production, the analytical laboratory plays a key role helping companies meet the rigors of drug development timelines. Sample throughput and accuracy of data become paramount. GERSTEL helps customers meet these challenges through the MPS line of LC and GC autosamplers and the MPS Sample Preparation capabilities.
GERSTEL offers customer focused solutions including complete GC/MS and LC/MS systems operated under a GLP regiment conforming 21 CFR Part 11 requirements. GERSTEL offers our own IQ/OQ-PV procedures for these solutions.
 

Extractables & Leachables

For pharmaceutical packaging, leachables and extractables studies are required to determine if packaging will leach contaminants into the product under normal storage conditions or if contaminants can be extracted by the product under well-defined more aggressive conditions. Thermal desorption combined with GC/MS is an efficient and sensitive screening method for contaminants in pharmaceutical packaging materials. With solutions based on the GERSTEL Thermal Desorption System (TDS) or theGERSTEL Thermal Desorption Unit (TDU), you will get an excellent quantitative and qualitative overview of any potential contamination for pharmaceutical development an quality control.

USP <467>

Residual solvents / organic volatile impurities (OVI) in pharmaceutical poducts, active pharmaceutical agents and excipients have to be monitored using headspace gas chromatography and flame ionization detection (HS-GC/FID). GERSTEL offers a completely automated solution based on the GERSTEL MultiPurpose Sampler (MPS) which meets the requirements set by USP monograph (US Pharmacopeia <467>) providing efficient and precise headspace-GC analysis.

Ethyl methane sulfonate (EMS)

Sulfonic acids are widely used during the synthesis and production of active pharmaceutical ingredients. In the presence of low molecular weight alcohols sulfonic acids can lead to the formation sulfonates which are considered as potential genotoxic compounds. Therefore their presence as trace level impurities in pharmaceutical ingredients is a concern which needs to be appropriately controlled. GERSTEL provides a solution to monitor EMS trace levels in an easy and robust way. All steps from sample preparation and derivatisation to GC/MS analysis are fully automated.
 

Automated Sample Preparation - improved performance and throughput

The GERSTEL MultiPurpose Sampler (MPS) specifically addresses today’s high throughput LC/MS an GC/MS demands and can be individually configured to work with all the standard systems in the market.

Application examples for Metabolomics, Biotechnology and Drug Discovery:

  • Determination of residual Organic Volatile Impurities (OVIs) in pharmaceutical products and intermediates
  • Leaching and migration of chemicals from pharmaceutical packaging
  • Parallel, automated monitoring of Bio-Transformations with aerobic and anaerobic micro-organisms in volumes up to 20 mL using  GERSTEL MPS Bioscreen
  • Screening of metabolites using SPME GC/MS with automated derivatization
  • Therapeutic drug sceening in small volumes of body liquids using Disposable Pipette Extraction (DPX)