Pharma Products Testing

Lancaster Laboratories

With 50 years of delivering comprehensive laboratory services, Lancaster Laboratories enables pharmaceutical and biopharmaceutical companies to advance candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness, and achievement of timelines. For a seamless service experience, customers team with scientists and project managers throughout the outsourcing process from testing to monthly reports to 24-hour online data access at LabAccess.comSM. Harmonized laboratory services at U.S. and Ireland sites as well as award-winning Professional Scientific StaffingSM at customers’ sites further broaden global drug development services.

Biochemistry

-          Spectrophotometry (CD, Bradford, A280, BCA)

-          Electrophoresis (CE, SDS-PAGE, 2D gels, Western blots, IEF)

-          Chromatography (AAA, peptide mapping, glycan profiling, SEC, CEX, RP-HPLC and UPLC)

-          Mass Spectrometry (Ion trap, LC/MS/MS, ESI-TOF, MALDI-TOF, Orbitrap)

 

Molecular & Cell Biology

-          Cell Banking and Storage

-          Cell Based Potency Assays (Cell proliferation, cAMP, reporter gene, cell surface receptor binding)

-          ELISA (HCP, Protein A, sandwich ELISA, competitive ELISA)

-          qPCR (rDNA, Viruses)

-          Genetic Stability (custom)

 

Virology

-          Viral Clearance (Infectivity assays, qPCR assays)

-          Viral Safety Testing (in-vitro, retrovirus, reverse transcriptase assays)

 

Microbiology

-          Sterility & Mycoplasma Testing

-          Endotoxin

-          Environmental Monitoring and Organism Identification

-          Particulates

-          Microbial Limits

-          Preservative Effectiveness

-          Water Testing

 

Pharmaceutical and Biopharmaceutical

  • Drug substance and drug product, clinical, registration, and commercial stability testing
  • Marketed product release testing
  • Stability storage and product retain programs
  • Raw material/excipient testing (USP/NF, EP, JP) and Melamine testing
  • Residual Impurity investigation and analysis
  • Comparator product testing and clinical ID/re-assay testing

Specialized Services

  • Method development, optimization, cGMP qualification and validation
  • Expedited raw material and excipient testing (USP/NF, EP)
  • Container testing on plastic and glass
  • Extractables/Leachables testing
  • Process/facilities validation – viral clearance, residual impurity testing, extractables & leachables, water testing, environmental monitoring, on-site sample collection
  • Consulting/protocol writing.

Five Service Models

  • Fee For Service- Lancaster Laboratories’ staff performs work on project-by-project basis.
  • Managed Hours- Staff performs work on project-by-project basis, utilizing a simplified quote and payment process based on hours used.
  • Full Time Equivalent - Lancaster Laboratories’ staff, at US or Ireland site, fully dedicated to client’s project needs.
  • Professional Scientific StaffingSM- Lancaster Laboratories’ staff, hired, trained and managed by Lancaster Laboratories, at client’s site.
  • Asset/Operation Ownership - Staff assumes full operational responsibility and acquires client’s facility and/or equipment.

Markets Served

With harmonized laboratory services within our U.S. and Ireland locations, Lancaster Laboratories serves a broad spectrum of companies in the pharmaceutical, biopharmaceutical, medical device, and animal health industries and has a proven track record of providing quality scientific solutions to the world’s largest pharmaceutical/biopharmaceutical companies as well as hundreds of virtual companies and CMOs.

 

Facilities

With facilities in Lancaster, PA and Dungarvan, County Waterford, Ireland, Lancaster Laboratories’ facilities offer cGMP-compliant laboratory services and operate under harmonized quality control programs and LIMS.

 

Lancaster Laboratories

2600 Clogherane, Dungarvan, Co. Waterford, Ireland
ph: +353 (0)58-48300