IDT Biologika Corporation is a contract manufacturer that provides end-to-end support from process development through manufacturing and fill/finish of clinical trial materials. We use our broad capabilities and a depth of technologies in collaboration with client partners to support the development of vaccines (including subunit antigens and viral vectors) and other biopharmaceuticals
We are ready to collaborate for your success.
• End-to-end operations
• GMP compliant (meets FDA, EMEA standards)
• BSL2 facility
• Expertise with live agents and proteins
• Extensive range of manufacturing platforms
• Cross-trained, flexible workforce
• Research cell and virus banks generation and testing
• Upstream Process development activities using single-use technologies for suspension and adherent cell lines (small scale and scale-up for process verifications) and establishment of processes for harvest, lysis, clarification
• Downstream Process development activities using column and membrane chromatography, variety of bioprocess filtration platforms (tangential flow, hollow fiber, depth filtration)
• Development of aseptic process for product that cannot be sterile filtered
• 6,000 square-foot upstream and 9,000 square-foot downstream manufacturing areas for the production of BSL2 biologics for clinical trials
• State-of-the-art GMP facilities with capabilities to cover various upstream and downstream production platforms for cell culture and virus manufacturing
• Quality Control and Quality Assurance practices and processes throughout the entire production process covering equipment validation, facility release, and approval of required documents to release of cGMP product
• Validated change-over and cleaning procedures between each project
• Grade A clean room for aseptic liquid filling of clinical trial materials for liquid
and lyophilized drug product
• Filling of vaccines, vectors, antibodies, recombinant protein therapies, and other biologics
• Automated fill line up to 7,000 vials, semi-automated fills
up to 2,000 vials and lyophilization up to 4,000 vials
• Inventory of standard 13mm container/closure stock for 2mL and 3mL vials
• Work with clients to develop custom configurations to
best meet product and storage requirements
• After filling, final product undergoes QC inspection, labeling
and storage at the appropriate temperature
Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878
about 3 miles from IDT Biologika Corporation
14975 Shady Grove Rd, Rockville, MD 20850
about 2 miles from IDT. Freeshuttle to/from IDT Biologika Corporation
Ronald Reagan Washington National Airport (aka “National”), Washington, DC
23.5 miles from IDT
Get on George Washington Parkway. Take I495N toward Maryland. Keep left at the fork to merge onto I-270 N. Take Exit 6B for MD-28/W Montgomery Ave toward Poolesville/Darnestown. Turn right onto Research Bld. Take the first right into the parking lot, 1405 Research Blvd.
Dulles, VA, 26.8 miles from IDT.
Stay on the Dulles Access Road for 13 miles. Take exit 13 toward Baltimore, merging onto 495N. Keep left at the fork to merge onto I-270 N. Take Exit 6B for MD-28/W Montgomery Ave toward Poolesville/Darnestown. Turn right onto Research Bld. Take the first right into the parking lot, 1405 Research Blvd.
Baltimore/Washington International Thurgood Marshall Airport (aka BWI)
Baltimore, MD, 42.5 miles from IDT
Continue to I-195W. Take Exit 4B for I-95 S toward Washington. Take the Exit onto MD-200 W (toll road) for 16 miles. Continue onto I-370W. Take the I-270 S exit on the left toward Washington. Take Exit 6A-6B, MD-28/W Montgomery Ave. Turn right onto Montgomery Ave. Turn right onto Research Bld. Take the first right into the parking lot, 1405 Research Blvd.
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