Protein Expression: Our 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: Our well-trained specialists scale up culture of protein-producing cells from pilot through cGMP production scale.
Protein Purification: Highly experienced 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.
Aseptic Filling and Conjugation: Our aseptic filling team has been filling liquid parenterals in our facility for over a decade. We can fill a wide range of volumes (0.1—100 ml), vial sizes (2—100 ml), and have filled aqueous and non-aqueous solutions, as well as suspensions and emulsions. We also formulate products, and have additional expertise in conjugation of small molecules to proteins.
Quality Control: Quality control is vital to our cGMP operations. The QC group 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: Our QA group is responsible for cGMP compliance, 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.