02.18.11
Alphora will expand its facilities and capabilities for API technology development across all areas, with a focus on R&D, cGMP operations, and analytical services. The company also plans to bring the number of employees to more than 90.
Alphora recently secured new research facilities, allowing a 50% increase in its process chemistry R&D capacity. Isolation technology is being added to support high potency compounds, and three separate isolators will be added for developing high potency API’s. Additional analytical equipment will include a GC/MS system for API characterization and control of Genotoxic Impurities (GTI’s). Also, a fourth cGMP Kilo Lab will be constructed, equipped with a 60L Buchi glass lined cryogenic vessel and supporting equipment. The kilo lab will have a dedicated HEPA filtered heating and ventilation system and pressure locks for class 100,000 use.
The company is also expanding warehouse capacity with new storage facilities for API’s, intermediates, raw materials and solvents, and a new Enterprise Resource Planning (ERP) system will be installed to provide greater control and flexibility to its plant operations.
Alphora recently secured new research facilities, allowing a 50% increase in its process chemistry R&D capacity. Isolation technology is being added to support high potency compounds, and three separate isolators will be added for developing high potency API’s. Additional analytical equipment will include a GC/MS system for API characterization and control of Genotoxic Impurities (GTI’s). Also, a fourth cGMP Kilo Lab will be constructed, equipped with a 60L Buchi glass lined cryogenic vessel and supporting equipment. The kilo lab will have a dedicated HEPA filtered heating and ventilation system and pressure locks for class 100,000 use.
The company is also expanding warehouse capacity with new storage facilities for API’s, intermediates, raw materials and solvents, and a new Enterprise Resource Planning (ERP) system will be installed to provide greater control and flexibility to its plant operations.