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- Address:
- 2540 Executive Drive
St. Paul, MN 55120
- Phone:
- (651) 675-2000
- Website:
- http://www.apptecls.com
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- Company Information:
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AppTec Laboratories Services is located at St. Paul, MN and is a unique single source for the biopharmaceutical/biotechnology and medical device/medical product industries – offering testing, contract research and development, and cGMP manufacturing services.
MANUFACTURING SERVICES: cGMP mammalian cell culture manufacturing services include cell banking; preclinical, clinical and in-market production; and final product formulation and fill. A full spectrum of services is offered for therapeutic recombinant protein and monoclonal antibody development and manufacture – from preparation and testing of cell banks, through cGMP manufacture and lot release testing of bulk drug substance and final drug product.
TESTING SERVICES: GLP- and GMP-compliant testing services include cell bank and virus bank characterization, lot release testing, viral and bacterial clearance projects, and stability studies. In addition, both validated and custom assay programs are offered for microbiology, molecular biology, virology, cell biology, analytical evaluations and in vivo safety tests.
TESTING & MANUFACTURING SUPPORT SERVICES: GLP- and GMP-compliant testing services include in vivo and in vitro biocompatibility/toxicology, hemocompatibility, chemistry, microbiology, sterilization validation, viral and bacterial clearance, environmental testing, quality assurance support/monitoring of manufacturing processes, reusable device validation, package testing, and custom studies.
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