Totowa Facility
Bulk Processing: This group uses proprietary chemical processing techniques to formulate microsphere powders containing drugs, antibodies or other substances.
Aseptic Filling: This group prepares containers and closures, and aseptically fills bulk powders and liquids into glass vials. Responsibilities also include 100% visual inspection of filled vials. Terminal sterilization is available through autoclaving or irradiation.
Quality Services: Quality control is vital to our cGMP operations. QC performs analytical testing of raw materials, intermediates, finished products, and stability samples. Environmental monitoring samples are tested at Laureate Pharma’s Princeton facility.
Quality Assurance: This group is responsible for cGMP compliance at both sites, including oversight of all production operations, auditing of operations and data, and control of documentation. In addition to overseeing the production operations, QA is responsible for environmental monitoring as well as tracking and trending of environmental data. The auditing function includes vendor audits, internal audits and auditing of records and reports. The documentation control function includes administration of SOPs, batch records, test methods and change control documents.