Eurofins Lancaster Laboratories Inc.
2425 New Holland Pike
PA 17601
Lancaster
USA
Phone: +1 717 656 2300
Fax: +1 717 656 3772
BioPharmaProductTesting@BPT.EurofinsUS.com
www.EurofinsLancasterLabs.com
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With 60 years of delivering comprehensive laboratory services, Eurofins Lancaster Laboratories, Inc. enables global pharmaceutical and biopharmaceutical companies 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.
Three flexible service models, including award-winning PSS Insourcing Solutions® at customers' sites and in-house FTE options, further broaden customized 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)
Chemistry
- Feasibility, method development, validation, qualification and transfer
- Full stability and release testing for clinical trial materials and finished products
- Dissolution and comparator study support
- Raw material and excipient testing
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.
Three Service Models
- Fee For Service- Eurofins Lancaster Laboratories' staff performs work on project-by-project basis.
- Full Time Equivalent - Eurofins Lancaster Laboratories' staff, at US or Ireland site, fully dedicated to client's project needs.
- PSS Insourcing Solutions®- Eurofins Lancaster Laboratories' staff, hired, trained and managed by Eurofins Lancaster Laboratories, at client's site.
Markets Served
With harmonized laboratory services within U.S., Eurofins Lancaster Laboratories, Inc. 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 Portage, MI, Eurofins Lancaster Laboratories' facilities offer cGMP-compliant laboratory services and operate under harmonized BioPharma Product Testing programs and LIMS.
Accreditations:
FDA, EMA, PMDA, GMP inspected
