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Last Updated: September 23, 2020

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Patent: 6,730,286

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Summary for Patent: 6,730,286
Title: Manufacturing process to control particle size
Abstract:A process for preparing a sterile injectable suspension of radiolabeled macroaggregated serum albumin suitable for use in scanning a mammalian patient consisting of: 1) purifying serum albumin with a saline solution; 2) buffering the purified serum albumin; 3) adding stannous halide in HCl solution to the buffered mixture to obtain a reaction mixture; 4) gradually heating and cooling the reaction mixture to form macroaggregate particles; 5) separating the macroaggregates from the reaction mixture; 6) suspending the macroaggregates in sterile water for injection; 7) adding purified serum albumin; 8) lyophilizing the suspension; and 9) reconstituting the radiolabeled lyophilizate with 99mTc. The invention also includes a process for preparing a stable, sterile lyophilizate of macroaggregate particles of human serum albumin consisting of steps 1-7.
Inventor(s): Schramm; Ernst (North Brunswick, NJ), Narra; Rama K. (North Brunswick, NJ), Kuczynski; Bruce (Highland Park, NJ), Zodda; Julius P. (Mercerville, NJ)
Assignee: Bracco Diagnostics, Inc. (Princeton, NJ)
Application Number:09/795,272
Patent Claims:see list of patent claims

Details for Patent 6,730,286

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Grifols Usa, Llc PLASBUMIN albumin (human) SOLUTION 101138 1 1994-09-26   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
Baxalta Us Inc. FLEXBUMIN albumin human INJECTION, SOLUTION 101452 1 2014-07-31   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
Csl Behring Ag ALBURX albumin (human) SOLUTION 102366 1 2009-01-06   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
Grifols Usa, Llc ALBUTEIN albumin (human) INJECTION, SOLUTION 102478 1 2019-12-15   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
Grifols Usa, Llc HUMAN ALBUMIN GRIFOLS albumin (human) SOLUTION 103352 1 2003-06-11   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
Csl Behring Llc ALBUMINAR-25 albumin (human) SOLUTION 103955 1 2009-01-06   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
Merck Sharp & Dohme Corp. ZOSTAVAX zoster vaccine live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 125123 001 2006-05-25   Start Trial Bracco Diagnostics, Inc. (Princeton, NJ) 2039-09-23 search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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