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FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

Anthera and Patheon Sign Manufacturing Agreement for Liprotamase Phase III Registration Trial

November 20, 2014 11:23 am | News | Comments

Anthera Pharmaceuticals has signed a manufacturing and supply agreement with the Patheon...

Vetter Opens Singapore Office to Support Growing Asian Healthcare Market

November 20, 2014 8:42 am | News | Comments

Vetter has announced the opening of a new representative office in Singapore. The announcement...

Pharmaceutical Processing’s Nov/Dec 2014 Digital Issue

November 13, 2014 11:13 am | Digital Editions | Comments

Pharmaceutical Processing’s Nov/Dec 2014 issue features an in-depth look at SAFC’s recently...

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Eurofins Acquires SF Analytical Labs

November 6, 2014 2:17 pm | News | Comments

Eurofins Scientific has announced the pending acquisition of SF Analytical (SFA) Laboratories. The transaction will close at the end of November. The acquisition strengthens Eurofins' growing presence in the US, as well as expands the current base of operations in the Midwestern United States.

GVK BIO to Acquire Vanta Bioscience

November 6, 2014 8:16 am | News | Comments

GVK BIO has announced the signing of a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment contract research organization operating out of Chennai, India.      

Catalent Expands Highly Potent and Cytotoxic Clinical Packaging Capabilities

November 3, 2014 7:55 pm | News | Comments

Catalent Pharma Solutions has announced that work has commenced to expand its highly potent and cytotoxic clinical drug packaging capabilities within its 450,000 sq. ft. Kansas City, MO campus.          

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LabCorp to Spend $6.1B on Covance

November 3, 2014 7:35 pm | by The Associated Press | News | Comments

LabCorp will pay about $6.1 billion in cash and stock to buy Covance in a tie-up that aims to improve clinical trial research for pharmaceuticals.                  

High Potency, High Reward

October 31, 2014 10:43 am | by Nikita Ernst, Associate Editor | Articles | Comments

SAFC, a global supplier of a a wide range of services to the biopharm and pharmaceutical industry, has recently expanded their Madison, Wisconsin facilities to neighboring Verona to rev up their high-potency API manufacturing capabilities.

Impax Announces R&D Reorganization, Layoffs

October 30, 2014 4:25 pm | News | Comments

Impax Laboratories has announced a reorganization of its research and development (R&D) organizations and a prioritization of the project portfolios within the generic and brand businesses          

Metrics Scientist Awarded Patent For Zero-Order Release Tablet Technology

October 28, 2014 1:35 pm | News | Comments

An expert scientist in pharmaceutical formulation development at Metrics Contract Services has been awarded a patent for intellectual property about controlled release technology.            

Mayne Pharma Appoints New VP of Quality for U.S. Operations

October 22, 2014 11:22 am | News | Comments

Q. Dwight Lewis is responsible for managing all quality-related functions to ensure that Mayne Pharma’s U.S. pharmaceutical operations – which range from laboratories to manufacturing lines – continue to comply with global regulatory agency and industry standards.

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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 the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

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 a series of adjustments to its Development Service related structures designed to support its customer base.        

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 organization, is pleased to announce that Thomas McGrath has been named Vice President of Quality.          

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.

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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.

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.                       

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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