Watch our latest webinar on Analytical Challenges and Solutions for Process and Drug-Product Related Residuals in Biopharmaceuticals.
Effective removal of impurities is a critical step in any drug development process. And because residual impurities are typically present at low concentrations within complex matrices, their detection and quantification can be quite difficult. For this reason, process validation studies require a broad set of residuals testing capabilities and expertise.
Whether you have residual impurities that are being introduced in upstream steps from culture growth and harvest (upstream residuals), in the downstream processes (downstream residuals), or through single-use technology, we have the breadth of capabilities and depth of industry knowledge to support all of your process validation testing needs.
- We have developed and qualified many highly sensitive and selective methods that can help shorten your process validation timelines and minimize costs.
- Our history of cGMP regulatory compliance ensures delivery of the highest quality data for your residual analysis.
- General Pharmacopoeia for the control of impurities in raw materials
- ICH Q3A, ICH Q3B, ICH Q3D and ICH Q6B
- Our expertise in biochemistry, molecular & cell biology, virology and chemistry provides you with a single source for all of your residuals testing needs.
- With extensive expertise in developing, validating and providing testing support for impurities, we can equip you with the best strategy for monitoring impurities and to accelerate your drug development programs.
Testing Available
Residual Solvents/Impurities
- USP <467> (all classes of residual solvents in current chapter)
- Customized method development/validation
- Validation of disposables for use in Bio-manufacturing
Process Related Impurities
- Customised method development/validation
- Product and API specific methodology
- Glycan analysis
- Related compounds
- Tracking/trending of resulting stability studies
- Microbiological purity testing
Degradation Products
Trace Metals
- Qualitative/Quantitative limit testing (using ICP approaches)
Experience
Upstream Residuals
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Downstream Residuals
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- Inducers
- Antibiotics
- Growth factors
- Media components
- Surfactants & Antifoams
- Pluronics
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- Antibiotics
- Buffers
- Surfactants & Antifoams
- Process-Enhancing and Purification Agents
- Solvents
- Metals
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Instrumentation
Mass Spectrometers
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Chromatography Equipment
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- Agilent GC-MS
- Waters Xevo Q-TOF LC-MS
- Waters Xevo TQ LC-MS/MS
- ICP-MS
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- Agilent and Shimadzu GCs with either headspace or direct injection sample introduction
- Waters/Thermo Scientific U/HPLCs
- Waters H-Class UPLCs
- Waters Classic UPLCs
- Beckman PA800+ Capillary Electrophoresis (CE)
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Detectors
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Other
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- Evaporative Light Scattering (ELS)
- Fluorescence (FL)
- Flame Ionization (FI)
- Conductivity
- Refractive Index (RI)
- Ultraviolet (UV)
- Photodiode Array (PDA)
- Charged aerosol detector (CAD)
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- NMR
- Multi-mode plate readers
- Fotospectrometers
- Atomic absorption (flame, furnace, oven)
- ICP-OES
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Contact us to discuss your needs.
