Laureate Pharma - Biopharmaceutical Development and Production

Laureate Pharma, a full service biopharmaceutical development and production company located in Princeton, NJ, provides superior bioprocessing services that accelerate new products from development through production. These specialized services include process design and development to full-scale cGMP production, purification, aseptic filling, testing, validation, analytical services and regulatory support. Laureate is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products.

CELL LINE OPTIMIZATION

Laureate Pharma's highly experienced cell-line development team ensures that this first critical step in the development phase of a biopharmaceutical is improved and maximized to yield cell line productivity in optimal media for downstream processing.

PROCESS DEVELOPMENT

Laureate Pharma's development staff has the expertise and experience to bring protein-based parenterals from lab scale to pilot scale and all the way to commercial production. Laureate Pharma’s team conducts small-scale pilot bioreactor runs, which are a vital step towards larger-scale production.

BIOREACTOR PRODUCTION

Laureate Pharma's 57,000ft² (5,300m²) facility in Princeton, New Jersey, includes development laboratories and manufacturing areas that house both hollow-fiber and stirred-tank bioreactors ranging from 20L to 2,500L in size. Laureate Pharma’s assets include multiple stirred tanks, wave systems and hollow fiber bioreactors.

PROTEIN PURIFICATION

Laureate Pharma uses automated chromatography development systems to scale up from bench to manufacturing, develop robust well-integrated processes and produce high purity product with good yield. From sample preparation to initial capture to polishing and final product formulation, Laureate Pharma's experienced team can purify any protein product to full cGMP requirements.

PROTEIN MODIFICATION AND CONJUGATION

Laureate Pharma's team of specialists can perform chemical conjugation of molecules with proteins. They have experience in performing conjugation for clinical and commercial products, and have special expertise in working with conjugation of chelators to proteins for radiolabelling.

ASEPTIC FILL / FINISH

Laureate Pharma offers aseptic fill and finish services to formulate and fill the final product. Laureate Pharma’s facility features a specialized filling machine whose product contact parts are all single use disposable. It operates within a class 100 filling area and can accommodate vials from 2ml - 100ml in size, with fill volumes from 0.1ml - 100ml. This equipment can accommodate batch sizes up to 20,000 vials or 200L of bulk volume.

ANALYTICAL DEVELOPMENT

Laureate Pharma's team of scientists routinely characterize protein properties, develop assays and test methods, transfer in client's methods, and / or adapt Laureate Pharma's methods to clients' protein products, according to clients' requirements.

QUALITY ASSURANCE SYSTEMS

Laureate Pharma's quality system consists of Quality Control (QC), Quality Assurance (QA), microbiology and validation. The integration of all these functional operations ensures compliance at every step of the cGMP and manufacturing process. The quality system department works closely with manufacturing groups to assure adherence to quality standards in all systems and processes throughout Laureate Pharma's facilities.

QUALITY SYSTEMS

Laureate Pharma's quality systems consist of cGMP documentation systems, audits and review systems, approval and release systems, vendor approval systems, cGMP compliance systems, change management systems, and corrective action and preventive action systems.

ANALYTICAL AND MICROBIOLOGY TESTING

Laureate Pharma offers analytical and microbiology testing for raw materials, in-process and finished protein, antibody and pharmaceutical products. Laureate Pharma's labs are registered with the US Food and Drug Administration (FDA) and licensed by the Drug Enforcement Administration (DEA) and the Nuclear Regulatory Commission.

VALIDATION

Laureate Pharma's validation program follows the Validation Master Plan, and includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of all critical equipment, a revalidation program, customer-specific equipment, and process validation and in-house staff supervision of contractors and consultants.