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The Lead

AMRI Closing Syracuse-Area Lab in July

April 17, 2014 11:33 am | News | Comments

Albany Molecular Research Inc. announced Wednesday that it will close its 12-year-old facility in Cicero on July 15. Some employees will be transferred to Albany, Cedarburg, Wis., England and India.         

OsoBio Appoints Director of Manufacturing

March 31, 2014 10:21 am | News | Comments

OsoBio has appointed Catherine R. Buck director of manufacturing. In her capacity, Buck is...

Quintiles Appoints New Head to Lead Global Risk Management for Real-World & Late Phase Research

March 27, 2014 8:15 am | News | Comments

Quintiles has announced that Stella Blackburn, M.B. B.S., has been appointed as the vice...

AMRI to Acquire Cedarburg Pharmaceuticals

March 24, 2014 7:58 am | News | Comments

AMRI has signed a definitive agreement to acquire all the outstanding shares of Cedarburg...

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Clinipace Worldwide Acquires Choice Pharma - Expands into Asia

March 11, 2014 11:09 am | News | Comments

With the merger, the company extends its global footprint to include 20 operational offices in 15 countries, including new offices in Taiwan, China, Hong Kong, South Korea, Vietnam, Singapore, and Malaysia.       

WuXi PharmaTech and Pacific Biomarkers Announce Collaboration

March 11, 2014 8:12 am | News | Comments

In a new agreement, PBI will provide access to its extensive menu of validated biomarker assays to support WuXi's integrated clinical trial testing services. This includes bioanalysis and central laboratory services for pharmaceutical and biotech companies performing clinical drug development in China.

Almac Expands Asia Pacific Operations, Establishes Regional Operations Centre in Singapore

March 11, 2014 8:03 am | News | Comments

Almac has announced the expansion of its clinical services and technologies capabilities to include on-the-ground leadership as well as technical, project and operational resources in Asia. The company has established regional hubs in Singapore and Japan to better enable the industry’s growing need to conduct clinical trials in Asia and/or manage global trials from the region.

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Progenitor Cell Therapy Announces Bi-Coastal Facility Expansions

March 10, 2014 8:33 am | News | Comments

Progenitor Cell Therapy has expanded both its Allendale, NJ and Mountain View, CA current Good Manufacturing Practice facilities to significantly increase its engineering and process development laboratories, and controlled environment space available for client needs.

Olympus Biotech Selling New Hampshire Biopharmaceutical Manufacturing Facility

March 3, 2014 11:40 am | News | Comments

Olympus Biotech today announced the initiation of an aggressive transaction process to find a buyer of its West Lebanon, NH manufacturing facility over the next 90 days. In recent months, the Company has received interest from buyers and contract manufacturing organization (CMO) partners, but no deal has been consummated yet.

Catalent Announces Two Senior Appointments to Expand Biologics Business

February 27, 2014 10:04 am | News | Comments

Andrew Sandford joins Catalent as Vice President Business Development, Biologics, and will focus on growth of the company’s existing biologics offerings and, Dr. Jennifer Mitcham jas been appointed Director, Business Development for Antibody-Drug Conjugates (ADC), Biologics.

PPD Enhances Bioanalytical Labs Biomarker Expertise

February 25, 2014 10:49 am | News | Comments

Pharmaceutical Product Development, LLC (PPD) has appointed Patrick Bennett as executive director of laboratory operations for a new biomarker services division of its bioanalytical laboratory.         

OsoBio Appoints New Director of Laboratories

February 24, 2014 3:27 pm | News | Comments

OsoBio has appointed Paul W. Stoker, Ph.D., director of its chemistry and microbiology laboratories. Stoker fills a position vacated when Kathleen Larese, OsoBio’s previous director of laboratories, became the company’s director of technical operations.

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CMO/CSO Roundtable

January 28, 2014 3:50 pm | by Mike Auerbach, Editor in Chief | Articles | Comments

Pharmaceutical Processing's Editor In Chief Mike Auerbach discusses current and future outsourcing trends with a select group of companies.                  

Mayne Pharma USA Names New President

January 28, 2014 11:42 am | News | Comments

Mayne Pharma Group Limited has named Stefan Cross as president of Mayne Pharma USA. Cross is responsible for leading all of Mayne Pharma’s existing business operations in the United States, and for spearheading new business development initiatives.

Unique Pharmaceuticals Registers as Outsourcing Facility with FDA

January 20, 2014 3:54 pm | News | Comments

Unique Pharmaceuticals, Ltd. has voluntarily registered with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility following guidance from the recently enacted Drug Quality and Security Act.   

CCBR-SYNARC and BioClinica Announce Merger

January 16, 2014 8:29 am | News | Comments

CCBR-SYNARC and BioClinica, Inc. have signed an agreement to merge their companies to create a global provider of specialized outsourced clinical services. The combined company will offer a portfolio of services uniquely tailored to conducting and managing global clinical trials on behalf of the world's premier pharmaceutical and biotechnology companies.

AAIPharma Completes Parenteral Manufacturing Facility Expansion

January 14, 2014 11:13 am | News | Comments

AAIPharma Services a provider of pharmaceutical analytical testing, product development and manufacturing services, announced today that it has completed a multi-million dollar expansion of its cGMP parenteral manufacturing facility in Charleston, S.C.

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Key Outsourcing Trends to Watch This Year

January 8, 2014 8:54 am | by Eric S. Langer, President and Managing Partner at BioPlan Associates, Inc. | Articles | Comments

Outsourcing of biopharmaceutical manufacturing has been growing for several years, to the point where contract manufacturing has become a common strategic decision for developers, extending beyond simple non-core activities and into more high-value, technical ones that leverage offerings from contract manufacturing organizations (CMOs) that some developers do not have in-house.

Ajinomoto Althea Inc. Appoints New President and Chief Executive Officer

January 6, 2014 8:35 am | News | Comments

Ajinomoto Althea Inc., a CMO providing development and manufacturing services for biotechnology and pharmaceutical companies, announced today the appointment of J. David Enloe Jr. as President and CEO. Mr. Enloe will be responsible for developing strategies to support the company's continued growth.

Quintiles Appoints Scott Evangelista to Lead Integrated Commercial Services and Solutions

December 12, 2013 10:21 am | News | Comments

Quintiles has announced the appointment of W. Scott Evangelista to serve as president, Integrated Commercial Services and Solutions. In this role, Evangelista is responsible for leading Quintiles’ global Commercial organization and the ongoing development and delivery of its related service offerings.

Charles River Laboratories Announces Organizational Changes to Enhance Global Capabilities

December 9, 2013 9:21 am | News | Comments

Charles River Laboratories today announced organizational changes which are designed to continue to improve the company’s operating efficiency across its global portfolio and enhance its ability to meet the needs of its clients. These changes represent the next step in Charles River’s continuing effort to position the Company as the partner of choice for early-stage drug development and to drive future growth.

Surveying The Industry’s Needs

December 4, 2013 9:35 am | by Mike Auerbach, Editor in Chief | Articles | Comments

Our annual reader survey looks at issues facing innovator companies and the CMO/CSOs that support them.                        

Unilife Rises on Supply Deal with Novartis

December 4, 2013 8:21 am | News | Comments

The company reported that Novartis wants to use one of its injectable drug delivery systems with an experimental drug in early-stage testing. Unilife said it will supply Novartis with a customized drug delivery device that will allow the Novartis drug to be delivered to a targeted organ.

AAIPharma Services and Cambridge Major Laboratories Appoint New CFO

December 3, 2013 8:14 am | News | Comments

AAIPharma Services, Corp. and Cambridge Major Laboratories, Inc. have announced the appointment of Eric Evans as the Chief Financial Officer (CFO) of the merged company (“AAI-CML”). Evans brings more than 25 years of experience in financial leadership roles; most recently as chief financial officer of AAIPharma Services, Corp.

Pharmaceutical Processing's November/December 2013 Issue

December 2, 2013 11:52 am | Digital Editions | Comments

In the November/December issue of Pharmaceutical Processing we profile Metrics’ clinical trial materials manufacturing facility located in Greenville, North Carolina. This issue also includes our annual CMO/CSO reader survey and our directory of service providers. Two articles on pure water discuss compendial water system maintenance and monitoring considerations, and automated and continuous TOC monitoring of ultra-pure water cycles.

Aptuit Names Jonathan Goldman As CEO

December 2, 2013 8:09 am | News | Comments

Timothy C. Tyson, Chairman of Aptuit LLC, announced today the appointment of Jonathan Goldman, MD as Chief Executive Officer (CEO), completing the company's senior management leadership team.  Dr. Goldman will focus his efforts on the growth of Aptuit as a leading provider of outsourced services in the early development space by establishing new partnerships with clients and pursuing strategic acquisitions.

Xcelience Hires Clinical Supplies VP; Opens Birmingham, UK Site

November 19, 2013 10:00 am | News | Comments

Xcelience announced today the hiring of Joseph Iacobucci as Vice President of Clinical Supplies and Services.  Mr. Iacobucci brings nearly 30 years of experience in clinical packaging and supply services, including 23 years as a Vice President for Clinical Systems, Inc. 

DSM to Buy Patheon, Create New Company

November 19, 2013 4:19 am | by The Associated Press | News | Comments

Dutch chemicals maker Royal DSM NV has struck a deal to buy Canada's Patheon Inc. for $195 million (145 million euros), combine it with its own drug manufacturing operations, and spin them off into a new larger company.     

Eurofins Lancaster Labs and Celsis International to Provide Rapid Micro Validation and Screening Services

November 18, 2013 8:02 am | News | Comments

Eurofins Lancaster Laboratories and Celsis International Ltd. announced today that they have entered into a collaboration through which Eurofins Lancaster Laboratories will provide contract rapid microbiology validation and screening services for the Celsis rapid detection technology platform.

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