Residual Impurities

Residual Impurities

Test Articles

We offer services in support of these test articles.

 
 

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 consultationfor Residual Impurities monitoring.

Why Choose 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.
  • Our 30-year history of cGMP regulatory compliance ensures delivery of the highest quality data.

Leadership of Group:

 

Jon S. Kauffman, Ph.D. – DirectorOver 20 years with Lancaster Laboratories

Robert Duff, Ph.D. – ManagerOver 5 years with Lancaster Laboratories

 

 
 

Testing Services Available

  • Antibiotics
  • Degradation Products
  • DNA, RNA
  • Extractables/Leachables
  • Host Cell Protein
  • Process-Enhancing Agents
  • Solvents
  • Surfactants & Antifoams

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

  • 34 elemental scans for ICP-OES and 64 elemental scans for ICP-MS, single or multiple element determinations

Fraction Collection for Isolation of Impurities and Residuals

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

  • Agilent GC/MS
  • Agilent LC-TOF
  • Thermo Scientific Accela LC/TSQ Vantage LC/MS/MS
  • Thermo Scientific Accela LC/LTQ XL Ion Trap
  • Thermo Scientific Accela LC/LTQ Orbitrap XL
  • Waters Quattro Micro LC/MS/MS
  • Waters XEVO-TOF

Chromatography Equipment

  • Agilent GCs (both headspace & direct injection)
  • Agilent/Waters/Thermo Scientific HPLCs
  • Dionex ICS-3000 Ion Chromatograph (IC)

Detectors

  • Corona Charged Aerosol (CAD+)
  • Electrochemical (ECD)
  • Evaporative Light Scattering (ELSD)
  • Fluorescence (FL)
  • Laser-Induced Fluorescence (LIF)
  • Photodiode Array (PDA)
  • Refractive Index (RI)
  • Ultraviolet (UV)
  • Flame Ionization Detector (FID)
  • Thermal Conductivity Detector (TCD)