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AMRI Expands Services to Protein Market

September 4, 2014 9:07 am | News | Comments

AMRI announced today that it has expanded into the protein market, with an initial focus on protein expression and purification. The global revenue of the total proteomics market is anticipated to grow at a compound annual growth rate of about 4.1% to about $9.2 billion by 2018.

MEDA Sells NJ Facility to DPT

September 4, 2014 8:17 am | News | Comments

Meda has signed an agreement to divest the manufacturing unit in Lakewood, New Jersey, to the...

PPD Acquires RCT Logic’s Exclusive License to Patented Clinical Trial Design Technology

September 3, 2014 10:44 am | News | Comments

PPD has acquired RCT Logic’s exclusive license from Massachusetts General Hospital for the...

Ajinomoto Althea Receives European GMP Certification

September 3, 2014 9:13 am | News | Comments

Ajinomoto Althea announced today that it has officially received its European GMP certificate...

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Particle Sciences Expands Drug Eluting Device Capabilities and Overall Clinical Trial Manufacturing Resources

September 2, 2014 2:39 pm | News | Comments

Particle Sciences, a CDMO for drug eluting devices, has added to its investment in development and manufacturing capabilities with the addition of a new 18mm extruder. The company now has over 6000ft2 of operating cleanroom and cGMP warehouse space including ISO5 (sterile) and two dedicated highly potent suites.

DPx Holdings B.V. Reaches Definitive Agreement to Acquire Gallus BioPharmaceuticals

August 28, 2014 11:55 am | News | Comments

DPx Holdings B.V., privately owned by JLL Partners and Royal DSM, has reached a definitive agreement to acquire all shares of Gallus BioPharmaceuticals, LLC, a contract manufacturing company specializing in biologics and current portfolio company of Ridgemont Equity Partners.

PPD Names New Executive Vice President and Chief Financial Officer

August 26, 2014 9:01 am | News | Comments

Pharmaceutical Product Development, LLC (PPD) today announced the appointment of Robert Hureau as executive vice president and chief financial officer. Hureau brings 25 years of experience and extensive financial expertise spanning the medical technology/life sciences, manufacturing and consumer sectors.

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Metrics Contract Service Reveals New Name and Logo

August 8, 2014 8:44 am | News | Comments

Metrics Contract Services, a full-service contract pharmaceutical formulation development and manufacturing organization, has adopted a new and more descriptive name.              

PCI Announces Definitive Agreement to Acquire Penn Pharma

July 30, 2014 8:38 am | News | Comments

Packaging Coordinators has reached a definitive agreement to acquire Penn Pharmaceutical Services Limited. Penn Pharma is headquartered in Tredegar, Wales in the United Kingdom and operates regional offices in New Hope, Pennsylvania and Tokyo, Japan.

Novogen and CanTx Appoint Contract Manufacturers to Produce Clinical Batches of Cantrixil

July 25, 2014 8:16 am | News | Comments

Oncology drug developer, CanTx Inc., and its parent company, Novogen Ltd., today announced that they have named two key contract manufacturing organizations (CMOs) to produce clinical batches of  the experimental anti-cancer drug, Cantrixil. 

Aptuit Names Executive VP, Business Development & Marketing; Enhances Sterile Drug Product Capabilities

July 16, 2014 11:33 am | News | Comments

Aptuit LLC has appointed Paul D. Overton, Ph.D., as Executive Vice President, Business Development and Marketing, making him responsible for all of Aptuit’s sales and marketing activities.           

Chiltern Acquires Ockham - Companies Merge Operations

July 15, 2014 11:45 am | News | Comments

Chiltern and Ockham, two full-service contract research organizations (CROs), today announce that Chiltern has acquired 100% of Ockham and that the companies will merge their operations. The combined company will be called Chiltern. Ockham's management team will join the management of the enlarged group, thus ensuring a seamless continuation of high quality services.

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Getting Very Personal: The PCT Story

July 8, 2014 2:35 pm | by Mike Auerbach, Editor In Chief | Articles | Comments

Mention the terms ‘cell therapy’ or ‘regenerative medicine’ and many in the general public are still confused as to what those terms actually mean. But those in the know understand that cell therapy is a growing and thriving industry, with great potential to change the face of modern healthcare.

AAIPharma Services and Cambridge Major Laboratories Name New CEO

July 8, 2014 8:54 am | News | Comments

AAIPharma Services Corp., a global provider of pharmaceutical analytical testing, product development and manufacturing services, and Cambridge Major Laboratories, Inc., a provider pharmaceutical API development and manufacturingservices, announced the appointment of Stephan Kutzer, Ph.D. as Chief Executive Officer (CEO), effective August 1, 2014.

Metrics Expands Drug Delivery Options with Spray Dryer Acquisition

June 27, 2014 9:01 am | News | Comments

Metrics Inc. has expanded its already robust options for enhancing drug bioavailability thanks to the recent acquisition of a BÜCHI B-290 Mini Spray Dryer. The dryer’s core capability is rendering powder from a solution, said Brad Gold, Ph.D., vice president of pharmaceutical development.

BASi Names Names New CFO and VP Bioanalytical Operations

June 12, 2014 8:27 am | News | Comments

Bioanalytical Systems, Inc. (BASi) today announced the appointment of Jeffrey Potrzebowski as Chief Financial Officer and James S. Bourdage, Ph.D., as Vice President Bioanalytical Operations.          

Xcelience Opens UK/European Packaging and Distribution Hub

June 10, 2014 11:24 am | News | Comments

Xcelience announced today the opening of a 3,000 square foot facility in Birmingham, UK, making it the first small to mid-sized American CDMO to launch international operations. The new plant will become a gateway for the Florida-based company’s clinical packaging and distribution services in the UK, Europe and abroad.

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Frontage Labs Plans Expansion of CMC Facility

June 3, 2014 9:51 am | News | Comments

Frontage Labs today announced plans to expand its chemistry, manufacturing and controls (CMC) facility in Exton, P.A. The expansion includes significant incremental capacity to existing services, and will also provide Frontage with additional room for future growth.

Bristol-Myers Squibb and Syngene International Extend Research Collaboration

June 3, 2014 8:18 am | News | Comments

Bristol-Myers Squibb and Syngene International, India’s largest contract research organization, today announced a five-year extension of their drug discovery and development collaboration in India.         

AMRI to Acquire Oso Biopharmaceuticals Manufacturing

June 2, 2014 9:01 am | News | Comments

AMRI has signed a definitive agreement to acquire all of the outstanding membership interests of Oso Biopharmaceuticals Manufacturing, for $110M in cash. OsoBio is a contract manufacturer of highly complex injectable drug products, including sterile liquid, suspension and lyophilized formulations.

WuXi PharmaTech Begins Operation of New High-Potency API Laboratory

May 28, 2014 8:13 am | News | Comments

WuXi PharmaTech today announced that its manufacturing subsidiary, Syn-The-All Pharmaceutical Co., Ltd. (STA), has begun operation of a high-potency active pharmaceutical ingredient (HPAPI) laboratory in Shanghai, thereby adding HPAPI processing to its portfolio of services.

PAREXEL Names Chief Scientific Officer

May 27, 2014 9:07 am | News | Comments

PAREXEL International, a global biopharmaceutical services organization, today named Dr. Sy Pretorius its Chief Scientific Officer. Dr. Pretorius currently serves as the company's Corporate Vice President and Worldwide Head of Early Phase, and will continue in that capacity in addition to assuming his expanded responsibilities.

Relypsa Announces Commercial Manufacturing Agreement With DSM Fine Chemicals

May 20, 2014 9:07 am | News | Comments

Relypsa, a biopharmaceutical company, today announced that it has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient for patiromer, the company's novel polymer in development for the treatment of hyperkalemia.

Lannett Announces Multi-Services Agreement with Sunshine Lake LLC

May 12, 2014 7:57 am | News | Comments

Lannett Company announced that it has entered into distribution and contract manufacturing services agreements with Sunshine Lake LLC, the U.S. subsidiary of the HEC Pharm Group (HEC) of Shenzhen, Guangdong Province, China.     

Pharmaceutical Processing's May 2014 Edition

May 9, 2014 12:00 am | Digital Editions | Comments

The May issue of Pharmaceutical Processing profiles PCI, a contract developer and manufacturer of custom NCEs, fine chemicals and generic APIs based in Newburyport, MA. We also take a look at the critical success factors clients evaluate when choosing a CMO. Our manufacturing services Q&A discusses current trends, issues and the future of pharmaceutical processing services. In addition we cover tablet coating, single-use technologies and QbD in test method development and validation.

Boston Therapeutics Signs Agreement With Patheon to Manufacture Pharmaceutical-Grade BTI-320 Tablets

May 6, 2014 8:02 am | News | Comments

Boston Therapeutics and its Hong Kong-based strategic partner Advance Pharmaceutical Company, have signed an agreement with Patheon to manufacture pharmaceutical-grade tablets of the company's lead product candidate BTI-320, a compound designed to reduce post-meal elevation of blood glucose.

CMOs Most Critical to Success Factors

April 30, 2014 8:38 am | by Eric Langer, President and Managing Partner, BioPlan Associates | Articles | Comments

Outsourcing continues to be an integral part of biopharmaceutical manufacturing, and facilities are outsourcing activities today at heightened levels. As a result, the contract manufacturing organization (CMO) community has seen an expansion of opportunities, leading to increased competition.  In this science and technology-driven environment, how can CMOs separate themselves from the pack?

Quintiles and Biogen Idec Announce Clinical Development Partnership

April 24, 2014 8:08 am | News | Comments

Quintiles, a provider of biopharmaceutical development and commercial outsourcing services, and Biogen Idec  have entered into a five-year strategic clinical development agreement. The multi-year collaboration is designed to leverage the expertise and experience from both organizations to optimize Biogen Idec’s clinical development processes.

Entrepreneurial Spirit

April 22, 2014 3:19 pm | by Mike Auerbach, Editor in Chief | Articles | Comments

PCI, Inc. a contract manufacturing and research organization based in Newburyport, MA that develops and manufactures NCEs, generic APIs and fine chemicals has grown from a small start-up to a company that can now take a product all the way from development to commercial production in a smooth and seamless process for its clients.

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