DR ANDERS BIOPHARM CONSULTING, LLC
State:
Florida
Branch Location:
Branch
Summary
Biopharmaceutical, analytical, GMP, method development, method validation, software validation, environmental monitoring (EM), stability testing, E&L testing, quality control
Profile
Address
State: Florida | County: Alachua | City: Newberry | Address: 19917 NW 6TH AVE | ZIP Code: 32669-2112 | Map URL: 19917 NW 6TH AVE
NEWBERRY FL 32669-2112
Description
Provide consulting services to the Biopharmaceutical industry, specializing in analytical sciences under Good Manufacturing and Good Laboratory practices (GMP & GLP). Consulting services are based on 30+ years as the leader of numerous CRO and CDMO firms for all aspects of analytical sciences supporting manufacturing of regulatory compliant products used in the pharmaceutical industry. Built 4 different GMP and GLP compliant laboratories for reporting regulatory compliant data for use in biopharmaceutical products for human and veterinary use.
Contact
Phone: 352-222-4459 | Email: [email protected]
Special Details
The most recent was building and leading a Quality Control analytical lab for a prime contractor to the DOD to support manufacturing of biopharmaceutical products as well as BSL3 vaccines. Building all such laboratories required staffing, installation, qualification and validation of all methods, instruments, associated software, training and oversight to support lot release, stability and all other associated tasks. Analytical techniques ranged from numerous chromatographic, electrophoretic, mass spectroscopy, general spectroscopy, cell based bioassays, immunological, physical tests, PCR, next generation PCR (NGPCR) and all microbiological methods supporting environmental monitoring (EM) and product release.
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