Lancaster Laboratories, Inc. - - BioPharm International

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Lancaster Laboratories, Inc.

Dec 1, 2005
BioPharm International
Volume 18, Issue 12

Company Description

One of the nation's premier testing laboratories, Lancaster Laboratories provides comprehensive analytical services in chemistry and microbiology for a broad spectrum of clients in the pharmaceutical, biopharmaceutical, medical device, and animal health industries. For more than four decades, we have delivered high quality laboratory services with strict regulatory compliance and close attention to our clients' project needs. Each project has an assigned project team, including scientists and a client service representative, to make sure that it is completed according to our client's requirements. With a large laboratory capacity, extensive technical expertise, and a multiple-shift staff, we can handle projects of any size.

Chief Biopharmaceutical Techniques Supported

Biochemistry

Electrophoresis
Biochromatography
Mass spectrometric capabilities
Protein qualification and characterization
Western blotting

Molecular Biology

Cell based assays
Immunogenicity testing
qPCR
ELISA

Biosafety

Viral testing
Mycoplasma
Sterility
Endotoxin

Support for facility and process validation

Facilities

The company is housed in a modern 175,000 ft.² facility equipped with state-of-the-art equipment. Chemistry services include a full array of spectrophotometric capabilities (LC–MS–MS, GC–MS, ICP–MS) and chromatographic capabilities (HPLC, SEC, GC, IC . A 9000 ft.² controlled microbiology laboratory contains a sterility test suite that includes two half-suit workstation isolators, four transfer isolators, an autoclave isolator integrated with a GMP sterilizer, and three VHP 1000 units. Technical areas include a controlled-access and temperature/humidity-monitored sample storage area. A separate limited-access building contains more than 20,000 ft.³ of stability chamber space accommodating 22 conditions, including photostability.

Markets Served

Lancaster Laboratories serves a broad spectrum of clients in the pharmaceutical, biopharmaceutical, medical device, and animal-health industries. Our active clients include a multitude of small to midsized pharmaceutical companies and nine of the ten largest pharmaceutical companies worldwide.

Major Services

Drug substance and drug product stability testing
Commercial product release testing
Stability storage and product retain programs
Excipient testing (USP–NF, EP, JP)
Container testing on plastic and glass
Extractables–leachables testing
Microbiology: sterility, endotoxin, preservative effectiveness, and organism identification
Biopharmaceutical: SDS-PAGE, Western blotting, protein quantitation, mycoplasma testing, ELISA, AAA, and mass spectrometry
Analytical method development and validation
Comparator product testing: methods development and validation, stability and release testing, and clinical re-assay testing
Consulting services