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Pharmaceutical Processing's October 2014 Issue

October 20, 2014 11:34 am | Digital Editions | Comments

The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain,  a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for...

Vetter Announces Personnel Changes in its Development Service Division

October 15, 2014 10:31 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), today officially announced...

LSNE Appoints New Vice President of Quality

October 15, 2014 8:11 am | News | Comments

Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing...

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PCI Opens North American Clinical Facility

October 10, 2014 8:27 am | News | Comments

The 97,000 square foot purpose built site was constructed in support of the growth PCI has experienced in its Clinical Trial services business, which includes drug development and manufacturing, laboratory services, packaging and storage services, global logistics, as well as client supporting consultative services for executing global investigational studies.

Tufts Center Report: Drug Companies Outline Ways Strategic Partnerships Can Boost Innovation

October 9, 2014 2:03 pm | News | Comments

Strategic relationships between drug developers and contract research organizations (CROs) are generating innovative approaches to clinical trial design and execution, but creating lasting value for both parties requires them to act in new ways, R&D executives from the pharmaceutical and biotech industry said at a gathering recently hosted by the Tufts Center for the Study of Drug Development.

Capsugel Expands Lipid Multi-Particulate Technology Offering

October 7, 2014 8:57 am | News | Comments

Capsugel announced today the broad commercial availability of its proprietary lipid multi-particulate (LMP) technology. Capsugel’s LMP technology is an innovative drug-delivery platform with multiple applications – including bioavailability enhancement, taste-masking and modified release – for both pharmaceutical and health and nutrition products.

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Survey: Majority of CROs Exchange Regulated Clinical Trial Documents via Outdated, Hard-to-Track Methods

October 7, 2014 8:17 am | News | Comments

The vast majority of contract research organizations (CROs) surveyed lag clinical trial sponsors in how they exchange trial master file (TMF) documents, according to the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs.    

WuXi PharmaTech Laboratory Testing Division Acquires XenoBiotic Laboratories

October 1, 2014 8:12 am | News | Comments

WuXi PharmaTech has acquired XenoBiotic Laboratories, Inc., a contract research organization with 27 years of successful operation that provides bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health, and agrochemical industries.

Pharmaceutical Processing's September 2014 Issue

September 29, 2014 1:48 pm | Digital Editions | Comments

  The September issue of Pharmaceutical Processing profiles SAFC’s new dry powder media manufacturing facility in Irvine, Scotland. In addition, coverage includes articles on highly toxic manufacturing and containment/isolator technologies. We also have a report on how CMOs are leading the adoption of new biopharm technologies. Other articles include a look at aseptic primary packaging, the challenges of scale-up and commercialization, optimizing vaccine processes, and the state of track and trace in the industry.  

Chiltern Acquires Pacific Clinical Research

September 29, 2014 10:10 am | News | Comments

Chiltern has acquired Pacific Clinical Research, a pan-Asian CRO based in Singapore. The move allows Chiltern to offer integrated services throughout the Asia-Pacific region and strengthens in particular Chiltern's oncology and anti-infective offerings.

Triple Threat

September 24, 2014 2:02 pm | by Mike Auerbach, Editor In Chief | Articles | Comments

Capsugel acquires Bend Research and Encap Drug Delivery to create a comprehensive solid dosage form solutions group.                       

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SAFC and Baxter BioPharma Solutions to Collaborate on ADC Offering

September 24, 2014 11:16 am | News | Comments

SAFC will contribute extensive expertise in conjugation and the manufacture of drug linkers, while BioPharma Solutions will offer world-class, sterile fill/finish services for final filling of ADC products.        

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 contract manufacturer DPT. The manufacturing facility is dedicated to global supply of the product MUSE.         

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 portfolio of patents related to its sequential parallel comparison design (SPCD). SPCD is an alternative method for conducting well-controlled clinical trials that substantially decreases the impact on trial outcomes of any placebo effect.

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 issued by the MHRA. The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market.

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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.

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.

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.          

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