Lancaster Laboratories, a global leader in comprehensive laboratory services, enables pharmaceutical and biopharmaceutical companies to advance candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness, and achievement of timelines.
With five service models to offer, our clients can choose the most efficient and cost-effective service solution for their project:
• Traditional Fee for Service - Our staff performs work on project-by-project basis.
• Managed Hours - Our staff performs work on project-by-project basis, utilizing a simplified quote and payment process based on hours used.
• Full Time Equivalent (FTE) - Our staff, at our site, fully dedicated to your project needs.
• Professional Scientific StaffingSM (PSS) - Our staff, hired, trained and managed by us, at your site.
• Asset/Operation Ownership - Our staff assumes full operational responsibility, and we acquire your facility and/or equipment.
No matter which service model is used, we provide 24-hour data access via our innovative and secure online tool at LabAccess.com SM.
Biopharmaceutical Techniques Supported
- 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)
- Viral Clearance (Infectivity assays, qPCR assays)
- Viral Safety Testing (in-vitro, retrovirus, reverse transcriptase assays)
- Sterility & Mycoplasma Testing
With harmonized laboratory services within our U.S. and Ireland locations, Lancaster Laboratories serves a broad spectrum of companies from 19 of the top 20 biopharmaceutical/pharmaceutical companies to hundreds of virtual companies and CMOs. We offer full CMC testing services for therapeutic proteins, vaccines, and nucleic acid based products.
• Method development, optimization, cGMP qualification and validation
• Drug substance and product characterization
• Full stability and release programs for clinical and marketed products
• Raw material and excipient testing (USP/NF, EP, JP)
• Microbiology including mycoplasma, sterility, endotoxin, and particulate matter
• EU release testing
• R&D and cGMP cell bank manufacturing, testing and storage
• Viral and molecular biology testing
• Process/facilities validation – viral clearance, residual impurity testing, extractables & leachables, water testing, environmental monitoring, on-site sample collection
• Consulting/protocol writing.
With facilities in Lancaster, PA and Dungarvan, County Waterford, Ireland, and a global capacity of over 260,000 square feet, Lancaster Laboratories has the capabilities to meet your global regulatory requirements. All of our facilities offer cGMP-compliant laboratory services and operate under the same SOPs and strict quality control program. Utilizing the same LIMS system and centralized billing, working with any of our global facilities is a seamless operation.
Lancaster Laboratories, Inc.