Residual Impurities
Test Articles
We offer services in support of these test articles.
- Download a detailed scope of our Biopharmaceutical Services
Residual Impurities
Residuals impurities are typically present at low levels in difficult sample matrices, and development and validation of assays and ongoing testing can be quite challenging. Whether you have impurities that are being introduced in upstream steps from culture growth and harvest or in the downstream processes–we provide expert testing, profiling and consultation for residual impurities monitoring.
Why Lancaster Laboratories?
- With extensive expertise in developing, validating and providing testing support for residual impurities, we can provide you with the best strategy for monitoring residual impurities and accelerating your drug development programs.
- You are assured of the highest quality data with our 30-year history of cGMP regulatory compliance.
Leadership of Group:
Jon S. Kauffman, Ph.D. – Director20 years with Lancaster Laboratories
Robert Duff, Ph.D. – Manager5 years with Lancaster Laboratories
Testing Services Available
- Antibiotics
- DNA, RNA
- HCP
- Process Enhancing Agents
- Surfactants & Antifoams
- Extractables/Leachables
- Solvents
- Degradation Products
Overview of Our Experience
- Residual DNA (qPCR)
- Validated assays for CHO, BHK, E. coli, Human, and Mouse DNA
- Host Cell Protein (ELISA)
- Cygnus Kit and custom assays
- Residual Antibiotics
- Kanamycin, ampicillin, tetracycline, penicillin, chloramphenicol, gentamicin sulfate, amphotericin B, hygromycin B, plasmocin
- Surfactants & Antifoams
- Triton-X, Pluronic, Tween 20 & 80,Antifoam A,B,C
- Process Enhancing Agents
- IPTG, DTT, Urea, Guanidine
- Residual Solvents
- USP <467> and custom methods
- Extractables & Leachables
- Design and execution of forced extraction, controlled extraction and leaching studies
- Metals
- 32 element scan, single or multiple element determinations
- Fraction collection for isolation of impurities and residuals
Details of our residual impurities experience: 
Contact
Request a quote to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.
Instrumentation:
Mass Spectrometers
- Thermo Scientific Accela LC/LTQ XL Ion Trap
- Thermo Scientific Accela LC/LTQ Orbitrap XL
- Thermo Scientific Accela LC/TSQ Vantage LC/MS/MS
- Applied Biosystems Voyager DE PRO MALDI-TOF
- Agilent LC-TOF
- Waters Quattro Micro LC/MS/MS
- Agilent GC/MS
Chromatography Equipment
- Agilent/Waters/Thermo Scientific HPLCs
- Agilent GCs
- Headspace (GC)
- Direct Injection (GC)
- Dionex ICS-3000 Ion Chromatograph (IC)
Detectors
- Ultraviolet (UV)
- Refractive Index (RI)
- Fluorescence (FL)
- Photodiode Array (PDA)
- Electrochemical (ECD)
- Evaporative Light Scattering (ELSD)
- Corona Charged Aerosol (CAD+)
- Laser-Induced Fluorescence (LIF)