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Solutions for Purifcation of Fc-fusion Proteins

Platform processes are valuable tools in process development. Applying them to complex fusion molecules made up of different structures, however, can lead to unexpected results. EA2 is a unique engineered molecule, and it did not fit well into a platform process. It does, however, have three potential affinity and pseudo-affinity sites, each target site having a platform purification unit operation. One site is the antibody Fc region for Protein A binding, but the product was too sensitive to low pHs for typical Protein A elution conditions, so a high pH elution process was developed instead. The other two pseudo-affinity sites proved to be unusable, as did ion exchange chromatography. The final process that was developed added hydrophobic interaction and mixed mode (HIC and AEX) chromatography polishing, with a solvent and detergent (S/D) treatment instead of the typical lowpH virus inactivation.This product points out the need for innovation and flexibility in cases where platforms do not work.
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Single-Use Technologies
A Contract Biomanufacturer’s Perspective

The closed and controlled environment of single-use technologies in a biopharmaceutical production process can significantly reduce processing time. A fully disposable option eliminates cross contamination, cleaning, and subsequent validation, reducing the use of water for injection. Lower operating costs, smaller equipment footprints, increased productivity, and rapid turnaround time are some of the major benefits that are driving the market demand for single-use technology in manufacturing. This article discusses a contract manufacturing organization’s perspective on the use of disposable technology in the biopharmaceutical production process.
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Cutting costs with contract manufacturing

Leading biopharmaceutical companies are finding that manufacturing and production offer tremendous opportunities to cut costs, reduce time and achieve overall excellence, and pharma companies eager to speed drug development cycles are increasingly turning to contract manufacturers to help streamline the process. But what challenges do they face in terms of choosing an outsourcing partner? And what issues need to be taken into consideration…
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Considerations for Aseptic Filling of Parenterals

Careful planning, innovative machine design, and rigorous attention to
detail will assure maximum product delivery and minimize timelines from project
initiation to completion. By the time a parenteral product arrives at our facility for
filling, a client has invested considerable time and significant resources in its
development and manufacture. Our experiences clearly demonstrate the
importance of planning and attention to detail for achieving a filling run that
enables that product to move efficiently to testing or market, helping to realize
the greatest value from…
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Bioprocessing and Partnering

There are a number of challenges facing the biomanufacturing industry,
from both the contract manufacturing organisation (CMO) and industry
perspectives. Biomanufacturing is a complex, labour-intensive and expensive
process and therefore it is extremely important to understand and balance
capacity versus demand and staffing level. Identifying, hiring, training and
retaining properly qualified personnel are very critical to the successful operation
of a facility, since biomanufacturing requires a very specialised and experienced
workforce. Staff must have technical expertise in specific areas including
upstream or downstream current Good Manufacturing Practice (cGMP)
manufacturing operations, process development, project management,
process engineering, quality assurance, analytical development, quality
control, regulatory compliance, and many other highly specialised functions.
Once on board…
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A rosy outlook for outsourcing biologics

Outsourcing providers have every reason to be happy. With an increasing volume
of new drugs entering the clinical trial pipeline, the usage occasions for contract
services are up. NGP spoke with Laureate Pharma’s Robert Broeze to find out how
he plans to become ‘most preferred CMO’.

Laureate Pharma can look forward to a future as impressive as its past. The contract
manufacturing organization (CMO) achieved record growth in 2006. It signed 14 new
agreements and increased its business backlog by more than 240 percent over 2005.
“We also increased our company workforce by more than 25 percent to handle the
ever-increasing workload. We are on track to completing the facility expansion,
and have added a new pilot production plant to expand the purification production
capacity,” says Robert J. Broeze, President and CEO.
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Facilitating Technology Transfer to Your CMO: How to ensure smooth technology transfers.

The following is a transcript of a podcast interview of Dr. Michael Ultee by BioPharm International, recorded at the 2008 BIO International Convention held in San Diego.

BioPharm: What are the biggest challenges in a technology transfer process? Are the challenges different at different stages of tech transfer?

Ultee: I think they are and they fall under a couple of categories. The first is the technical area. The processes that come to us arrive at different levels of development. If a process is already well developed, then it is essentially a pure technology transfer…
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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…