Our Commitment to Quality

Quality Systems

Our Quality Systems consist 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.

At Laureate we work with clients to ensure that quality agreements are put in place with each client, tailored to the client needs. We write specifications and have them approved by the client for each client-specific raw material, packaging component, in-process material and finished product. We also write Master batch and formulation and fill records, which are approved by the client. The client may perform audits at any time for specific issues and once a year globally.

Quality Assurance Systems

Our Quality Assurance Systems consist of cGMP Documentation System (batch/fill records, standard operating procedures (SOPs), specifications test methods); Audit and Review System (batch records, equipment logs, test records, validation data); Approval and Release System (raw materials, intermediates, final product to client); Vendor Approval System (components and outside testing); cGMP Compliance System (training, in-house audits); Change Management System (approved documents, facilities equipment and processes) and Corrective action and preventive action (CAPA) system (deviations and incidents, corrective/ preventive actions, investigations, remediation plans).

Quality Control and Microbiology Testing

We offer Quality Control and microbiology testing for raw materials, in-process and finished protein, antibody and pharmaceutical products.  Our labs are registered with the US Food and Drug Administration (FDA) and licensed by the Drug Enforcement Agency (DEA) and the Nuclear Regulatory Commission. Our analytical testing programs cover biopharmaceuticals, pharmaceuticals and radiopharmaceuticals.

Our Microbiology team conducts environmental monitoring of all clean room areas, and performs speciation tracking and trending data, Water for Injection (WFI) sampling and testing, oversight of outside testing, sterility and microbial limits/bioburden. We also monitor our facility’s nitrogen, oxygen, carbon dioxide, compressed air, clean steam, and reverse osmosis/deionization (RO/DI) water system.

Validation

Our validation program follows Validation Master Plan, and includes installation qualification (IQ) operational qualification (OQ) and performance qualification (PQ) of all critical equipment, revalidation program, customer-specific equipment and process validation and in-house staff supervision of contractors and consultants.

Regulatory Assistance

Laureate’s facility is registered with the FDA, the DEA, state and federal, and the NRC, state and federal. Our team has experience working with the FDA, Canadian and European agencies. Our staff has prepared chemistry, manufacturing, and controls (CMCs) for investigational new drugs (INDs), biologic license applications (BLAs), new drug applications (NDAs) and European dossiers. We provide the CMC and regulatory support by working closely with the client’s regulatory groups and preparing CMC sections for INDs and other regulatory submissions (site DMF reference letter (Type V).

Pharmacy News

Laureate and ARIUS Cooperation

Princeton, NJ and Paris, France, March 27, 2008: Laureate Pharma, Inc., a full-function facility of biopharmaceutical development and protein manufacturing, claimed nowadays that it has signed a contract with Cytheris SA, a clinical phase of biopharmaceutical facility oriented on trials and development of new treatment for immune stimulation. According to the contract, Laureate will produce Cytheris’ lead product candidate, Interleukin-7 (IL-7), a complete glycated recombinant human protein and crucial growth-stimulating…

Laureate Announces Second Manufacturing Agreement with Cytheris

Princeton, NJ and Paris, France, March 27, 2008: Laureate Pharma, Inc., a full-function facility of biopharmaceutical development and protein manufacturing, claimed nowadays that it has signed a contract with Cytheris SA, a clinical phase of biopharmaceutical facility oriented on trials and development of new treatment for immune stimulation. According to the contract, Laureate will produce Cytheris’ lead product candidate, Interleukin-7 (IL-7), a complete glycated recombinant human protein and crucial growth-stimulating factor for…

Laureate Pharma Agreement with Alopexx Pharmaceuticals

Laureate To Manufacture Alopexx’s Product Candidate On April 10, 2008, Laureate Pharma, Inc., a large company engaged in biopharmaceutical development and protein production reported that it has concluded a contract manufacturing agreement with Alopexx Pharmaceuticals on the production of Alopexx’s mAb F598 antibody under cGMP conditions. This antibody will be used in clinical trials and also for fighting Staphylococcus aureus infections. The details of the agreement were not announced. “We are happy that Laureate…

Laureate Pharma Company – Press Release

FOR IMMEDIATE RELEASE Laureate Pharma Launches New Contract Manufacturing Venture Company offers services for development and manufacture of biopharmaceuticals and sustained-release products Princeton, NJ – May 21, 2002 – Laureate Pharma Company announces the launch of contract manufacturing services at its two sites in New Jersey. Biopharmaceutical development and manufacturing services will be provided at a cGMP manufacturing facility in Princeton, NJ. Services related to sustained release microsphere products will…

Laureate Pharma Extends its Agreement with Cytogen for Manufacture of PROSTASCINT®

Princeton, NJ – October 25, 2006: Laureate Pharma, Inc. announced today that it has renewed its agreement with Cytogen Corporation for the cGMP manufacture of ProstaScint®, Cytogen’s proprietary monoclonal antibody immunoconjugate that is used for imaging in patients diagnosed with prostate cancer. Under the agreement, Laureate will provide cGMP protein production, purification, conjugation of Cytogen’s proprietary linker chelator and aseptic filling services to support Cytogen’s commercial ProstaScint® requirements. Terms of…

Laureate Pharma & DrugAbuse Sciences – Press Release

FOR IMMEDIATE RELEASE Laureate Pharma and DrugAbuse Sciences Announce Commercial Manufacturing Services Agreement. Princeton, NJ – June 24, 2002 – Laureate Pharma L.P. and DrugAbuse Sciences, Inc. announce the initiation of a contract manufacturing agreement related to a sustained release microsphere product. Under the agreement, Laureate Pharma will provide manufacturing services for DrugAbuse Sciences’ Naltrexone Depot product, currently in clinical trials. Terms of the agreement were not disclosed. “We are…

LAUREATE PHARMA COMPLETES SALE OF TOTOWA, NJ OPERATIONS TO DISCOVERY LABORATORIES FOR $16.0 MILLION

Laureate’s Bioprocessing Facility at Princeton, NJ to be Expanded Princeton, NJ – January 3, 2006 – Laureate Pharma, Inc., a wholly-owned subsidiary of Safeguard Scientifics, Inc. (NYSE: SFE), announced today that it had completed the previously announced sale of its Totowa, NJ operations to Discovery Laboratories, Inc. (NASDAQ: DSCO) for $16.0 million in cash. Laureate Pharma, a provider of bioprocessing services to pharmaceutical and biopharmaceutical companies, conducts its principal operations…

Laureate Biopharma Appoints Ann M. Daus, Ph.D. Vice President, Quality

– Leads implementation of Laureate’s strategic quality plan – PRINCETON, N.J., March 16, 2011 — Laureate Biopharmaceutical Services, Inc., a full-service biopharmaceutical contract development and manufacturing organization, today announced the appointment of Ann M. Daus, Ph.D, as Vice President, Quality. Dr. Daus will lead the implementation of Laureate’s strategic quality plan, recruit new leaders to supplement the quality management team, lead the strategic expansion of testing services and improve companywide…

Laureate Pharma Honored as Emerging Life Sciences Company of the Year

Laureate recognized for its business growth, leadership team and service innovation by the Eastern Technology Council Princeton, NJ, November 20, 2008: Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that it has been named the “Emerging Life Science Company of the Year” by The Eastern Technology Council, the largest technology and life sciences trade association in the greater Philadelphia, PA region. The company was honored…

Laureate Pharma Announces Manufacturing Agreement with Alopexx Pharmaceuticals, LLC

Laureate To Manufacture Alopexx’s Product Candidate Princeton, NJ, April 10, 2008: Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that it has entered into a cGMP contract manufacturing agreement with Alopexx Pharmaceuticals, LLC. According to the agreement, Laureate will produce Alopexx’s mAb F598 antibody under cGMP conditions. This antibody is planned for use in clinical trials, and later for commercial production for the treatment and…

Laureate Announces Manufacturing Agreement with ARIUS for Trop-2 Targeting Antibody

Laureate to Manufacture ARIUS’ Product Candidate Trop-2 Signal Transduction Antibody Princeton, NJ, January 31, 2008: Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that it has entered into a cGMP contract manufacturing agreement with ARIUS Research, Inc., a biotechnology company focused on discovering and developing the next wave of antibody therapeutics to treat cancer and other diseases, for its Trop-2 Signal Transduction Antibody Program. Laureate…

LAUREATE PHARMA ANNOUNCES AGREEMENT WITH TRUBION PHARMACEUTICALS

LAUREATE TO MANUFACTURE TRUBION’S TRU-016 PRODUCT CANDIDATE Princeton, NJ, January 30, 2007: Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced it has entered into an agreement to produce Trubion Pharmaceuticals, Inc.’s TRU-016, a novel protein for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Terms of the manufacturing agreement were not disclosed. Trubion’s TRU-016 program targets CD37, an antigen present on B…