Princeton Facility

Protein Expression: These scientists use cell culture and molecular biology techniques to maximize cell line productivity and adapt cells to grow well in defined media compatible with downstream processing.

Bioreactor Operations: This group scales up culture of protein-producing cells from pilot through cGMP production scale.

Protein Purification: These scientists focus on development and operation of robust purification processes suitable for cGMP manufacturing. They also perform viral-clearance studies on these processes as required.

Conjugation & Aseptic Filling: This group has performed chemical conjugation of molecules with proteins, and is responsible for all cGMP aseptic filling of bulk parenteral products in the Princeton facility. This responsibility includes process validation via media fills and weekly germicidal cleaning of the facility.

Quality Control: Quality control is vital to our cGMP operations. QC performs analytical testing of raw materials, intermediates, finished products, and stability samples. Other responsibilities include assay development and stability testing. Environmental monitoring samples are tested at Laureate Pharma's fully integrated microbiology lab.

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.

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