Downstream Processing

Protein Purification

At Laureate, we use 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, our experienced team can purify any protein product
to full cGMP requirements. We have custom designed methods to purify a variety of
protein-based therapeutics using various chromatography and filtration techniques.
In appropriate cases we also use disposable charged membrane cartridges in lieu of
column chromatography for purification. Our column sizes vary to accommodate
feed volumes, protein concentration and binding capacity of the resins.
Some of the techniques we use include:

  • Affinity
  • Ion exchange
  • Hydrophobic Interaction
  • Size exclusion
  • Tangential Flow Filtration
  • Diafiltration
  • Ultrafiltration

We purify and manufacture protein-based therapeutics using semi automated
chromatography skids with flow capabilities ranging from 2L/min to 30L/min.
Our purification experts have routinely purified hundreds of grams to Kilogram
quantities of proteins. We perform process validation, including viral clearance studies
at off-site qualified laboratories.

Protein Modification and Conjugation

The scientists at Laureate have the unique capability and track record in developing radiolabeled antibodies for cancer therapy. Such antibodies have enhanced potency
in cancer therapy, directing potent radiation to specific areas of disease.
Process development and cGMP manufacturing for clinical trials of these entities,
however, pose logistical challenges.

At Laureate, we have a team of specialists who can perform chemical conjugation of molecules with proteins for clinical and commercial scale and have special expertise in working with conjugation of chelators to proteins for radiolabelling. We have an ongoing manufacturing contract producing commercial scale radiolabeled antibodies for a biopharmaceutical company.

Analytical Development

Our team of scientists based on clients’ requirements, 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. We
develop formulation that optimizes product quality and stability. We perform
the following tests routinely on the protein products:

  • Electrophoretic assays
    • SDS PAGE, IEF
  • Immuno assays
    • ELISA, RIA
  • Chromatographic assays
    • HPLC assays with RI & UV detectors
    • GC with FID and TCD detectors
  • Endotoxin Removal assays
    • Gel clot, Kinetic

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…