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In Eurofins, the pharmaceutical industry has a reliable laboratory partner to collaborate in drug development and quality control. We provide bioanalytical and global safety testing worldwide for clinical research programs. Globally, we work with several of the top 10 pharmaceutical companies and serve many smaller pharma and biotechnology organizations as well as CROs and phase 1 units. Visit our website detailing our global capabilities covering the whole chain of drug development at http://pharma.eurofins.com.

Here in the US, we have several locations decicated to first rate pharmaceutical testing, and their combined capabilities provide the industry with an unmatched and comprehensive portfolio of services.

Eurofins Pharma Services

Eurofins Pharma Services is an analytical Contract Research Organization (CRO) serving the pharmaceutical industry since 1990. We provide clients with peace of mind through our scientific excellence and exemplary client and FDA audit record, especially when they are facing difficult analytical challenges or adverse regulatory issues. We specialize in the development, validation, and routine performance of GxP-compliant methods for all stages of drug discovery and development from early ADME studies, to stability and release testing of the finished product. Available technologies include HPLC, GC, GC-MS, LC-MS, and immunoassay. Available services include:

• GMP method development and validation
• GMP product testing
• Pre-clinical and clinical bioanalysis
• Biomarker detection and quantitation
• Animal health product testing

For more information on our services, please visit us at http://pharma.eurofins.com or email us at Pharma_Customer_Care@eurofinsus.com.

Pharma Central Laboratory

Dedication You Can Rely On

Eurofins Global Central Laboratory is fully focused and dedicated to providing standardized, high quality global central laboratory services to support all phases of clinical trials. With over 20 years of experience serving pharma, biotech, and CROs, our laboratory testing portfolio has become one of the widest available in the pharmaceutical industry and offers the synergy of integrated safety assessment, exploratory biomarkers, end point biomarkers, PK/PD, therapeutic drug monitoring, immunogenicity testing, genomic testing and a full range of services to support infectious disease drug development.

Eurofins Global Central Laboratory supports its customers with wholly-owned and harmonized laboratory facilities strategically located in the United States, Europe, India Singapore and China. If required, we extend global coverage through standardized laboratory partners to reduce costs, accelerate logistic timelines, or to meet local needs for a given study.

Eurofins Global Central Laboratory is committed to providing the highest quality services, as well as accurate, timely results capturing the planned completion date, and expert advice from our highly qualified team of experienced scientists. As data integrity is of paramount importance, we continually monitor both data quality and our laboratory operations to ensure that the highest standards are maintained.

Laboratory Testing Services Capabilities

• Global Clinical Safety and Specialized Testing
• Method Development and Validation
• Feasibility Assessment and Scientific Consultancy
• Biomarker Services
• PK/PD
• Therapeutic Drug Monitoring
• Biopharmaceutical Services
• Global Infectious Disease Services
  • Microbiology to support clinical trials
• Antimicrobial surveillance
• Specialty microbiology testing required by the US FDA to characterize new drugs
• Genomic Testing

Broad Range of Supporting Services

• Complementary integration of Bioanalytical, Genomic, and Global Infectious Disease Services in one project
• Global standard operating procedures
• Global QA and QC
• Standardized instruments and analytical methods enable the use of global reference ranges
• Accreditations, certifications and endorsements for a wide range of pharmaceutical industry regulatory requirements such as CAP, CLIA, ISO15189, ISO17025, GCP compliant, OECD GLP, NGSP Level 1, CDC LSP
• Global coverage to minimize sample transportation and logistics
• Logistics support and courier management
• Sample management and storage
• Investigator site support
• Multilingual Regional Client Support Centers on three continents
• Open and proactive communication
• Single point of contact at Project & Data Management
• Global LIMS system
• Real-time validated global results database via secured Data Portal 

For more information, please click here. Alternatively, please contact us via email: clinicaltrials@eurofins.com

Pharma Early Development

Preclinical Toxicology and Pharmacology

Through its partner laboratories, Eurofins offers full GLP- compliant preclinical and pharmacology test services to the pharmaceutical and biotech industries. Services include:

Toxicology

Acute/Subacute/Chronic mammalian

• Rodents & Non-rodents

Genetic Toxicology

• Ames
• Moue Lymphoma
• Chromosome Aberration
• Micronucleus Test

Carcinogenicity
DART

• Fertility and Embryonic Development
• Teratology
• One and Two Generation Reproductive
• Developmental Neurotoxicology

Central Nervous System

• Motor Activity
• FOB

Pathology

• Necropsy
• Histpathology
• Clinical Pathology

Drug Metabolism/PK

Radiolabeled/Non-radiolaoelged
Mass Balance/Excretion
Bioanalysis

Safety Pharmacology

Cardiovascular

• In-vivo Radiotelemetry
• NHP
• Canine
• Rodent
• Minipig
• In-vitro
• hERG

Central Nervous System

• Irwin
• Rodent
• NHP

Respiratory

• Plethysmography
• Blood gas analysis

Gastrointestinal Transit
Renal Function

Pharmacologic Efficacy

Metabolic Disease
Inflammation
Gastrointestinal
Central Nervous system
Cardiovascular
Obesity
Animal model development

You can find more detailed information on our capabilities at:
www.productsafetylabs.com.

Pharm/Biopharm 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, Inc.
2425 New Holland Pike
PO Box 12425
Lancaster, PA 17605-2425
717-656-2300
www.LancasterLabsPharm.com