Technical Bulletin

Expertise and Experience


Our management and senior staff combine the unique experience, expertise and capabilities required for the development and manufacture of protein-based biopharmaceuticals.

Our FDA registered cGMP facility has successfully produced both clinical trial size runs as well as commercial product for over ten years.

Biopharmaceutical Contract Manufacturing Services

Cell Line Development


  • Majority of senior scientists are PhDs with an average of 20 years’ experience working with mammalian cell lines. Responsible for cell line development, establishing stable cell lines, medium development, stability analysis and cell culture process development.

Process Development


  • Team members have published well over 50 scientific papers, hold patents and have produced proteins in various different types of cell lines, bringing many to trial or market. Broad industry experience in biotechnology and pharmaceutical firms. Responsible for every phase of process transfer and development.

Pilot & Scale-up Production


  • Bioreactor operations management and staff have produced MAbs and recombinant proteins in stirred-tank, hollow-fiber and disposable bag bioreactors for a number of industry leading companies. Responsible for bioproduction from cell line to purification stage.

Protein Purification


  • Analytical and process engineering staff has vast knowledge in the selection of optimal chromatography methods and resins and filtration methods. Responsible for buffer formulation, protein purification, viral clearance and process validation.

cGMP Contract Manufacturing


  • Operations management and quality systems staff average over 20 years of production experience of biopharmaceuticals, specifically mammalian cell based drugs. Responsible for timely and economical biopharmaceutical contract manufacturing under strictest quality standards and compliance with federal guidelines as well as client expectations.

Aseptic Filling and Finishing


  • Specially trained engineering staff and machine operators have filled well over a million vials—without a single reject. Aseptic fill lines can accommodate liquid batch sizes up to 20,000 vials or 200 liters of bulk volume.

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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…