Biopharmaceuticals • Protein Purification • Purification • Gmp • Protein Chemistry • Formulation • Protein Production • Technology Transfer • Fda • Analytical Chemistry • Fermentation • Biotechnology
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Compositions For Nasal Drug Delivery, Methods Of Making Same, And Methods Of Removing Residual Solvent From Pharmaceutical Preparations
Kris P. Antonsen - Berkeley CA Rajiv Nayar - Richmond CA Wei Wang - Alameda CA Margaret Caudle - Alameda CA Michael A. Shearer - Fairfield CA Neville M. Concessio - San Francisco CA
The present invention relates to pharmaceutical compositions for delivery of drugs intended to reside in the nose, compositions for nasal administration of drugs, e. g. , antiviral agents, and particularly antiviral agents comprising the human major rhinovirus receptor, also known as intercellular adhesion molecule-1 (ICAM-1); to methods of making said nasal drug compositions, and to an improved process for the removal of residual solvent from pharmaceutical matrices.
A method for purifying human or other alpha-l proteinase inhibitor ( -PI) from a solution (which may be derived from the milk of a transgenic animal expressing the -PI) which comprises contacting the solution with a cation exchange substrate under conditions sufficient to bind non-tg- -PI contaminants to the substrate while not substantially binding tg -PI to the substrate. Using the preferred embodiment, the purified tg -PI contains as little as 40 pg non- -PI-whey protein per mg total protein.
Compositions Of Prokaryotic Phenylalanine Ammonia-Lyase Variants And Methods Of Using Compositions Thereof
Augustus O. Okhamafe - Concord CA, US Sean M. Bell - Novato CA, US G. Nick Zecherle - Novato CA, US Kris Antonsen - San Rafael CA, US Yanhong Zhang - San Rafael CA, US Kieu Ly Tran - San Francisco CA, US Paul A. Fitzpatrick - Berkeley CA, US Emil D. Kakkis - Novato CA, US Michel Claude Vellard - San Rafael CA, US Daniel J. Wendt - Walnut Creek CA, US Mubarack Muthalif - Novato CA, US
Assignee:
BIOMARIN PHARMACEUTICAL INC. - NOVATO CA
International Classification:
A61K 38/51 A61P 3/00 A61P 7/00 C12N 9/88
US Classification:
424 945, 435232
Abstract:
Provided herein are phenylalanine ammonia-lyase (PAL) variants produced by prokaryotes, wherein such prokaryotic PAL variant has a greater phenylalanine-converting activity and/or a reduced immunogenicity as compared to a wild-type PAL. Further provided are compositions of prokaryotic PAL and biologically active fragments, mutants, variants or analogs thereof, as well as methods for the production, purification, formulation, and use of such compositions for industrial and therapeutic purposes, e.g., treating hyperphenylalaninemia, including phenylketonuria, and other disorders, including cancer.
Vivian W. Lee - Alamo CA Kris P. Antonsen - Berkeley CA
Assignee:
PPL Therapeutics (Scotland) Limited - Edinburgh
International Classification:
C07K 118 C07K 122
US Classification:
530413
Abstract:
A method for purifying human or other alpha-1 proteinase inhibitor (. alpha. sub. 1 -PI) from a solution (which may be derived from the milk of a transgenic animal expressing the. alpha. sub. 1 -PI) which comprises contacting the solution with a cation exchange substrate under conditions sufficient to bind non-tg-. alpha. sub. 1 -PI contaminants to the substrate while not substantially binding tg. alpha. sub. 1 -PI to the substrate. Using the preferred embodiment, the purified tg. alpha. sub. 1 -PI contains as little as 40 pg non-. alpha. sub. 1 -PI-whey protein per mg total protein.
Compositions Of Prokaryotic Phenylalanine Ammonia-Lyase Variants And Methods Of Using Compositions Thereof
- Novato CA, US Sean M. Bell - Novato CA, US G. Nick Zecherle - Novato CA, US Kris Antonsen - San Rafael CA, US Yanhong Zhang - San Rafael CA, US Kieu Ly Tran - San Francisco CA, US Paul A. Fitzpatrick - Berkeley CA, US Emil D. Kakkis - San Rafael CA, US Michel Claude Vellard - San Rafael CA, US Daniel J. Wendt - Walnut Creek CA, US Mubarack Muthalif - Novato CA, US
Provided herein are phenylalanine ammonia-lyase (PAL) variants produced by prokaryotes, wherein such prokaryotic PAL variant has a greater phenylalanine-converting activity and/or a reduced immunogenicity as compared to a wild-type PAL. Further provided are compositions of prokaryotic PAL and biologically active fragments, mutants, variants or analogs thereof, as well as methods for the production, purification, formulation, and use of such compositions for industrial and therapeutic purposes, e.g., treating hyperphenylalaninemia, including phenylketonuria, and other disorders, including cancer.
Compositions Of Prokaryotic Phenylalanine Ammonia-Lyase Variants And Methods Of Using Compositions Thereof
- Novato CA, US Sean M. Bell - Novato CA, US G. Nick Zecherle - Novato CA, US Kris Antonsen - San Rafael CA, US Yanhong Zhang - San Rafael CA, US Kieu Ly Tran - San Francisco CA, US Paul A. Fitzpatrick - Berkeley CA, US Emil D. Kakkis - San Rafael CA, US Michel Claude Vellard - San Rafael CA, US Daniel J. Wendt - Walnut Creek CA, US Mubarack Muthalif - Novato CA, US
International Classification:
C12N 9/88 A61K 47/48 A61K 38/51
Abstract:
Provided herein are phenylalanine ammonia-lyase (PAL) variants produced by prokaryotes, wherein such prokaryotic PAL variant has a greater phenylalanine-converting activity and/or a reduced immunogenicity as compared to a wild-type PAL. Further provided are compositions of prokaryotic PAL and biologically active fragments, mutants, variants or analogs thereof, as well as methods for the production, purification, formulation, and use of such compositions for industrial and therapeutic purposes, e.g., treating hyperphenylalaninemia, including phenylketonuria, and other disorders, including cancer.
Biomarin Pharmaceutical Inc.
Executive Director, Regulatory Strategy Implementation
Biomarin Pharmaceutical Inc. Mar 2015 - Jan 2018
Executive Director, Purification Process Development
Biomarin Pharmaceutical Inc. 2013 - Feb 2015
Senior Director, Purification Process Development
Biomarin Pharmaceutical Inc. Jun 2006 - 2012
Director, Purification Process Development
Chiron Corporation Nov 2002 - May 2006
Senior Process Scientist
Education:
Massachusetts Institute of Technology 1982 - 1989
Doctorates, Doctor of Philosophy, Chemical Engineering
University of California, Berkeley 1981 - 1982
Master of Science, Masters, Chemical Engineering
Uc Santa Barbara 1975 - 1979
Bachelors, Bachelor of Science, Chemical Engineering
Skills:
Biopharmaceuticals Protein Purification Purification Gmp Protein Chemistry Formulation Protein Production Technology Transfer Fda Analytical Chemistry Fermentation Biotechnology
Languages:
English
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