Lancaster Laboratories, Inc.

Dec 01, 2005
By BioPharm International Editors

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 (USPNF, 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

LANCASTER LABORATORIES, INC.
2425 New Holland Pike PO Box 12425 Lancaster, PA 17605-2425

TELEPHONE
717.656.2300

FAX
717.656.3772

WEB ADDRESS
http://www.lancasterlabs.com/

EMPLOYEES
750

FOUNDED
1961