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Scientifically Adept - Platform Agnostic: Particle Sciences Positions Itself as a Bioavailability Tool for Most Dosage Forms

January 22, 2015 11:50 am | by Mike Auerbach, Editor In Chief | Articles | Comments

Particle Sciences, a drug development services company located in Bethlehem, Pennsylvania, has based its business model on being platform/technology agnostic. Bring them your drug development, formulation or dosage form problem and they will apply the right set of tools and technology to advance your project.

Catalent Expands Integrated Softgel Operations Through Coating and Packaging Investment In Eberbach, Germany

January 22, 2015 10:44 am | News | Comments

Catalent Pharma Solutions will adding new coating and blister packaging equipment at its 360,000...

Baxter BioPharma Solutions Joins PBOA; Nelson Patterson Elected To Board

January 21, 2015 9:29 am | News | Comments

The Pharma & Biopharma Outsourcing Association (PBOA) today announced that Nelson Patterson...

Catalent Biologics and MGC Pharma Announce Partnership for Biomanufacturing in Asia

January 19, 2015 12:29 pm | News | Comments

Catalent Pharma Solutions and Mitsubishi Gas Chemical Company, Inc. (MGC), have entered into a...

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AMRI Receives NIH Contract Award

January 19, 2015 9:29 am | News | Comments

AMRI has received a 10-year federal contract award from the NIH for drug development and manufacturing services. This NIH/National Institute of Neurological Disorders and Stroke award will support NIH's Drug Manufacturing and Formulation Program, which is a component of the Blueprint Neurotherapeutics Network. AMRI has supported the NIH BPN since 2011, providing chemistry services and discovery technologies.

Boehringer Ingelheim and Sanofi to Collaborate on Manufacturing Biopharmaceuticals

January 15, 2015 8:34 am | News | Comments

Boehringer Ingelheim and Sanofi announced today that they enter into an alliance to extend Sanofi’s manufacturing capacity network for therapeutic monoclonal antibodies.              

Catalent and Sanofi to Collaborate On Smartag™ Antibody-Drug Conjugate Technology With Sanofi’s Proprietary Antibodies

January 15, 2015 8:07 am | News | Comments

Catalent Pharma Solutions has entered into a collaboration with Sanofi-Aventis Recherche & Développement, a Sanofi Company to implement Catalent’s proprietary SMARTag™ technology in the development of next generation Antibody-Drug Conjugates (ADCs).

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SGS Expands Biomarker Services

January 14, 2015 8:28 am | News | Comments

SGS Life Science Services today announced that its laboratory in Poitiers, France, has successfully completed a full analytical validation of the novel Meso Scale Discovery (MSD®) V-PLEX 10-plex Proinflammatory Panel I, for use with human plasma samples.

Capsugel Acquires Monash University’s Proprietary Ionic Liquids Technology

January 12, 2015 9:32 am | News | Comments

This novel technology uses lipid-like counter-ion salts to improve the solubility of drugs in lipid-based liquid, semi-solid and multiparticulate formulations. This technology adds to Capsugel Dosage Form Solutions’ growing suite of bioavailability enhancement technologies and capabilities.

AMRI to Develop and Manufacture Parenteral Products for Genovi Pharmaceuticals

January 12, 2015 8:51 am | News | Comments

AMRI will initially provide cGMP manufacture and analytical support for the registration of five product candidates. AMRI will be reimbursed for technology transfer activities, analytical development and manufacture of regulatory submission batches. In addition, AMRI is eligible to receive additional payments for achieving product delivery milestones.

Aptuit Sells Two Sites to AMRI

January 9, 2015 8:04 am | News | Comments

Aptuit has divested its aseptic clinical manufacturing site in Glasgow, UK to Albany Molecular Research, Inc., and has entered into a definitive agreement with AMRI to acquire the West Lafayette, Indiana solid-state chemistry business for a total consideration of $60 million.

PPD and SNBL to Provide Clinical Development Services in Japan

December 24, 2014 8:25 am | News | Comments

Pharmaceutical Product Development and Shin Nippon Biomedical Labs have formed a joint venture that will provide a full range of clinical development services in Japan, including Phase I-IV clinical trial monitoring, project management, site intelligence and activation, biostatistics, data management, medical writing, pharmacovigilance, regulatory and FSP services.

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Bayer Selects Cardinal Health as U.S. Based Contract Manufacturer for Xofigo Injection

December 18, 2014 1:20 pm | News | Comments

Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of Xofigo.  As part of the agreement, Cardinal Health will build a state-of-the art, 64,000 square foot facility in Indianapolis, which will be dedicated exclusively to the manufacturing of Xofigo.

PCI Synthesis Sponsors New England CRO/CMO Council

December 17, 2014 8:54 am | News | Comments

The non-profit New England CRO/CMO Council is open to CROs and CMOs operating in and around Boston, the nation's largest life sciences cluster. The Council is designed to market the cluster and to provide the broader BioPharma community with a means of accessing local CRO’s, CMOs and other suppliers to meet their current and future outsourcing requirements.

PPD and ERT to Partner on Drug Development

December 16, 2014 9:10 am | News | Comments

Pharmaceutical Product Development and ERT today announced a strategic partnership to facilitate delivery of ERT’s comprehensive solutions for patient safety and efficacy endpoint data collection to help biopharmaceutical clients conduct clinical trials in a more efficient and cost-effective manner.

Scilabs Nutraceuticals Responds to FDA Consent Decree

December 15, 2014 8:18 am | News | Comments

Scilabs Nutraceuticals Inc.™, a contract manufacturer of nutraceuticals based in Irvine, California, has commented on the recent consent decree that it entered into with the FDA, in which the company agreed to suspend nutraceutical manufacturing operations.

Vetter Opens Third Cleanroom for Clinical Syringe Projects

December 11, 2014 9:59 am | News | Comments

Vetter has announced that its U.S. early-stage development site located at the Illinois Science + Technology Park in suburban Chicago, has completed the next step of its expansion with the addition of a third cleanroom. Clinical syringe projects are now being accepted at the facility, which can handle preclinical through phase II projects.

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Avid Bioservices to Expand cGMP Manufacturing Capacity

December 10, 2014 8:49 am | News | Comments

Avid Bioservices, the contract manufacturing subsidiary of Peregrine Pharmaceuticals, has initiated an expansion of its biomanufacturing capacity. The new production facility will more than double Avid Bioservices' current manufacturing capacity in a state-of-the-art facility design.

Meda to End Penicillin Contract with Recipharm; Layoffs Forecast

December 4, 2014 1:44 pm | News | Comments

Meda, a Recipharm’s customer, announced that they will transfer supply of their mainly Swedish penicillin products and manufacture offshore with other suppliers. The manufacturing contract with Recipharm Strängnäs will therefore be terminated as of December 31, 2015.

Catalent and Sellas to Collaborate on Therapeutic Reprofiling of Zolpidem

December 4, 2014 10:00 am | News | Comments

Catalent Pharma Solutions has reached an exclusive development and licensing agreement with Swiss-based development-stage biopharmaceutical company SELLAS Life Sciences Group, to support the development and therapeutic reprofiling of zolpidem using Catalent’s OSDrC® OptiDose™ drug delivery technology.

Noble Life Sciences Acquires Spring Valley Laboratories

December 3, 2014 10:38 am | News | Comments

Noble Life Sciences, a provider of preclinical drug development services, has announced the acquisition of Spring Valley Laboratories, a full service, GLP-compliant, preclinical contract research organization for the development of drugs, vaccines, and medical devices.

Catalent and Valerion Therapeutics to Develop New Treatments for Orphan Genetic Disorders

December 2, 2014 3:23 pm | News | Comments

The collaboration will focus on the delivery of muscle-protein fusions, and treatment of multiple indications, in the fields of muscular dystrophies, glycogen storage diseases, myopathies and enzyme-deficiency disorders.     

Vetter Adds Flexible Serialization Services

December 2, 2014 11:51 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), now offers the option of clearly identifying packaging used for drugs. Vetter's comprehensive and flexible serialization service is in response to stricter guidelines from the regulatory authorities of many countries aimed at combatting counterfeit drugs.

Johnson Matthey Acquires Pharmaceutical Manufacturing Capacity in Scotland, UK

December 2, 2014 11:43 am | News | Comments

Johnson Matthey, a provider of pharmaceutical services, APIs and catalyst technologies, has announced completion of an acquisition of pharmaceutical manufacturing capacity in Scotland, U.K. The 109,000 sq. meter site was acquired to meet increasing demand for custom pharmaceutical services and active ingredients utilising enhanced manufacturing capabilities.

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 division of DPx Holdings B.V.  The contract provides for Patheon to support the production of the Sollpura clinical drug product for Anthera's Phase III registration trial.

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 was made at a ceremony attended by members of local government agencies and a number of executives of pharmaceutical/biotech companies with a presence in the Asian region, as well as Vetter executives.

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 expanded high-potency API manufacturing facilities in Madison, WI. In addition, our Annual CMO/CSO Survey is included in this issue detailing the trends driving the CMO/CSO market. Other articles take a look at elastomeric closure in parenteral manufacturing, cleanroom energy efficiency, package integrity, deduster design efficiency, and desiccant canister design and feeding options.

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.

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