Excelse Bio
Chief Strategy Officer
Integrity Bio
President
Lyotip
President
Integrity Biosolution Jan 2003 - Aug 2008
Founder and President
Amgen 1991 - 2002
Associate Director at Pharmaceutics
Education:
University of Massachusetts Amherst 1984 - 1988
Doctorates, Doctor of Philosophy
Skills:
Biopharmaceuticals Biotechnology Drug Development Gmp Technology Transfer Formulation Drug Delivery Pharmaceutics Lyophilization Contract Manufacturing Manufacturing Vaccines
Bruce Kerwin - Thousand Oaks CA, US Byeong Chang - Thousand Oaks CA, US Lei Shi - Thousand Oaks CA, US
Assignee:
Amgen Inc. - Thousand Oaks CA
International Classification:
A61K 38/19
US Classification:
530350, 530402, 514 2, 514561
Abstract:
The present invention provides for improved compositions comprising a PEGsTNF-R1 which, in addition to having useful higher concentrations, demonstrate decreased viscosity (
Byeong Seon Chang - Thousand Oaks CA, US Roger Wongjung Liu - Moorpark CA, US
International Classification:
A61M 37/00
US Classification:
604 89, 604 82, 604 92
Abstract:
A container closure delivery system that is suitable for lyophilized pharmaceutical injectable powder products is disclosed. The system comprises storage stable powder formulations and a container closure assembly design wherein the formulation can be filled and lyophilized with a standard fill finish equipment, and the formulations and lyophilization processes are optimized to produce a powder that readily dissolves upon contact with a diluent, thereby facilitating the direct injection of the lyophilized product without the need for a separate reconstitution/mixing/priming step.
Compact Medication Reconstitution Device And Method
A container usable for lyophilization, storage, and reconstitution of medication having only two parts, one of which is a plug component having a flow path terminating in a side outlet port and a second of which is a barrel component. The barrel component has a spiral mixing channel near its distal end in which powder medication is stored and upon reconstitution, yields a gradient concentration. The inner wall of the barrel includes a longitudinal diluent groove. To connect the plug outlet port with the longitudinal diluent groove, the plug or barrel has a 360 distribution groove encircling the plug and connecting to the plug outlet port. Regardless of what rotational orientation the plug has to the barrel, the diluent will always reach the mixing channel.
Byeong Seon Chang - Thousand Oaks CA, US Roger Wongjung Liu - Moorpark CA, US
International Classification:
A61M 37/00 A61M 31/00
US Classification:
604 82, 604 92, 604518, 604 85
Abstract:
A method of storing and delivery a drug, such as by lyophilizing and reconstituting, comprises performing both storing and delivering with the same container closure assembly. The container closure is assembled in a preparation configuration during which lyophilization occurs. After lyophilizing, the powdered drug is forced into a spiral channel in the container closure assembly by a plunger. The plunger leaves substantially no head space for the powdered drug, and the assembly is sealed thereby now being in the storage configuration. For delivery of the stored powdered drug, a syringe of diluent is introduced to the container assembly thereby changing the assembly to the delivery configuration. The spiral channel is continuous between an input end and a delivery end with the delivery end being in fluid communication with a delivery outlet of the assembly. The assembly includes a diluent flow path that forces the diluent into a spiral channel at only the input end.
RALPH W. NIVEN - REDWOOD CITY CA, US CLIFFORD D. WRIGHT - BOULDER CO, US BYEONG S. CHANG - THOUSAND OAKS CA, US
International Classification:
A01N037/18 C12P021/06 A01N043/04
US Classification:
514/002000, 514/044000, 435/069100
Abstract:
The present invention relates to the pulmonary administration of a therapeutic protein by means of powdered pharmaceutical compositions suitable for inhalation therapy. In particular the invention relates to dry powder formulations of secretory leukocyte protease inhibitor (SLPI) for pulmonary delivery. Exemplary pharmaceutical compositions contain SLPI and a pharmaceutically acceptable carrier in the form of a dry powder which is typically less than about 10% by weight water. About 50% to 95% by mass of the powder comprises particles or agglomerates of particles having a diameter within the range of from about 1.0 microns to about 8 microns, with a mass median diameter ranging from about 3.0 microns to about 6 microns.
Ralph Niven - Redwood City CA, US Clifford Wright - Boulder CO, US Byeong Chang - Thousand Oaks CA, US
Assignee:
Amgen, Inc.
International Classification:
C07K001/00 A01N037/18 C12N009/00
US Classification:
530/350000, 514/002000, 435/183000
Abstract:
The present invention relates to the pulmonary administration of a therapeutic protein by means of powdered pharmaceutical compositions suitable for inhalation therapy. In particular the invention relates to dry powder formulations of secretory leukocyte protease inhibitor (SLPI) for pulmonary delivery. Exemplary pharmaceutical compositions contain SLPI and a pharmaceutically acceptable carrier in the form of a dry powder which is typically less than about 10% by weight water. About 50% to 95% by mass of the powder comprises particles or agglomerates of particles having a diameter within the range of from about 1.0 microns to about 8 microns, with a mass median diameter ranging from about 3.0 microns to about 6 microns.
L-Methionine As A Stabilizer For Nesp/Epo In Hsa-Free Formulations
Tiansheng Li - Thousand Oaks CA, US Byeong Chang - Thousand Oaks CA, US Christopher Sloey - Sherman Oaks CA, US
International Classification:
A61K038/22
US Classification:
514/012000
Abstract:
The present invention relates to single use and multi-dose pharmaceutical formulations comprising a biologically active agent and methionine, wherein said formulations demonstrate improved stability, and wherein said formulations do not contain human serum albumin.
Compositions Of Pegylated Soluble Tumor Necrosis Factor Receptors And Methods Of Preparing
Bruce Kerwin - Thousand Oaks CA, US Byeong Chang - Thousand Oaks CA, US Lei Shi - Thousand Oaks CA, US
International Classification:
A61K038/17 C07K014/715
US Classification:
514/012000, 530/350000
Abstract:
The present invention provides for improved compositions comprising a PEGsTNF-R1 which, in addition to having useful higher concentrations, demonstrate decreased viscosity (
Name / Title
Company / Classification
Phones & Addresses
Byeong S. Chang President
Integrated Biosystems, Inc Noncommercial Research Organization