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Podcasts

Webcast: Strategies in Bioavailability Enhancement of Poorly Permeable Small and Large Molecular Entities (BCS III & IV)
May 3, 2011—Sponsored by Evonik Degussa Corporation

Webcast: Metabolic Syndrome: Important Considerations in Trial Design
May 5, 2011 (North America) and May 10, 2011 (Europe)—Sponsored by SGS

Webcast: Quality by Design for Biologics: Biopharmaceutical Characterization
May 24, 2011 (Europe) and May 26, 2011 (North America)—Sponsored by SGS

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
June 21, 2011 (North America) and June 23, 2011 (Europe)—Sponsored by SGS

Podcast: A conversation with Jim Greenwood

Events

ExcipientFest
May 10–May 11
Baltimore

Interpack
May 12–May 18
Düsseldorf, Germany

2011 AAPS National Biotechnology Conference
May 16–May 18
San Francisco, CA

Cleanrooms — Standards & Technology
May 17
Edinburgh, United Kingdom

Cleaning Validation
May 17–May 19
Bethesda, MD

Sterile Pharmaceutical Dosage Forms: Basic Principles
June 1–June 2
Bethesda, MD

More events


FindPharma Search
April 28, 2011 PharmTech.com

News

FDA Releases Strategic Priorities for 2011-2015
FDA has released a list of its strategic priorities for the next five years to address new global challenges.
Click Here to Read More

IMS: Growth in Drugs Stalls, Generic Use Up
The IMS institute has released its report on the use of medicines in the United States during 2010. Click Here to Read More

Pfizer and Shanghai Pharmaceutical Partner in China
Shanghai Pharmaceutical and Pfizer have signed a memorandum of understanding for the companies to jointly pursue potential business opportunities in China. Click Here to Read More

Warner Chilcott to Axe 500 European Jobs
Warner Chilcott announced its intentions to restructure, placing 500 Western European jobs on the line. Click Here to Read More


Product Spotlight

Sanitary tote dumper is compliance-ready

National Bulk Equipment’s (NBE) sanitary tote dumper is built to be compliance-ready for sanitary pharmaceutical manufacturing. The design thus eliminates the need for retrofitting, expensive reinspections, and extended cleaning cycles. The unit’s internal and external welds have a 32-Ra finish. In addition, the 8-gal/min hydraulic system gives the dumper a 16,000-lb lift-carriage capacity.

NBE’s RotoLink carriage linkage enables the machine to rotate the tote 180°, which is a 33% greater rotation than competing units. This rotation tips the container completely upside down and helps to ensure that sticky or clumped material is released from the tote, thus reducing waste.

The dumper’s angled-plane, rounded-radius framework and highly finished plate are designed to facilitate cleaning in place (CIP) by reducing solids buildup and aiding moisture removal. Personnel can fit the unit’s closed systems (e.g., the dumper hood) with dynamic spray devices, and the design of the hood helps improve the impingement force of the spray to improve the effectiveness of CIP.

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Company Notes

The biopharmaceutical company Alnylam Pharmaceuticals and the nanotechnology firm Precision NanoSystems have agreed to jointly develop small lipid nanoparticles (sLNPs) using microfluidics technology.

Advertisement:
Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks – slim, tube-shaped packets the size of a stick of gum – offer impressive benefits: fill accuracy, portability, product differentiation, reduction in paper and foil usage, product differentiation and ideal sample option. http://www.ropack.com/en/service/primary-packaging/stick-pack

The solid-state research company Avantium has spun out its solid-state research and drug preformulation business into a new company named Crystallics, following a management buyout. The spin-out is part of Avantium’s plan to focus on its catalyst and chemicals activities.

Advertisement:
Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress® Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required. Read More

Baxter International has agreed to acquire the specialty pharmaceutical company Prism Pharmaceuticals. The acquisition includes a total consideration of up to $338 million, consisting of an upfront cash payment of $170 million at closing, and up to $168 million in future sales-based milestone payments. The transaction is expected to close in the second quarter of 2011, subject to customary closing conditions.

Advertisement:
Management of Water/Cleaning Validation
Shimadzu’s new TOC-L Series analyzers are ideal for the management of the total amount of organic carbon in pharmaceutical manufacturing processes. They feature the patented catalytic combustion oxidation method, fully automated sample pretreatment, and a wide measurement range, and when combined with a solid sample combustion unit, the carbon in attached residues can be measured for cleaning validation. Learn More

The biopharmaceutical company Caliber Biotherapeutics has opened a plant-based manufacturing facility capable of producing 10–100 million doses of vaccines per month, and hundreds of thousands of doses of protein biotherapeutics, such as monoclonal antibodies, according to the company. In addition, Caliber also will develop a proprietary product pipeline for cancer and infectious diseases, using cell- and microbial-based production systems.

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The latest in news and information from Bosch Packaging Technology At our new Blog http://boschpackagingpharmana.wordpress.com Currently on the blog 150 years of Packaging History, single-use dosing technology updates, and a capsule filling system comparison.

Eli Lilly has announced a partnership with the medical-technology firm Medtronics for delivering a potential new medicine to the brain, using an implantable drug-delivery system. The goal of this pact is to develop a therapeutic approach for Parkinson's disease that combines Lilly's biologic, a modified form of glial cell-derived neurotrophic factor (GDNF), with Medtronic's implantable drug-infusion system technology.

Advertisement:
Rapid delivery of accurate results with the superior sensitivity of Xevo TQ-S
The unprecedented levels of sensitivity, selectivity and accuracy of Xevo TQ-S from Waters, allows scientists to develop a fast flexible SPE/LC/MS/MS platform for the simultaneous quantitation of multiple amyloid ß peptides in cerebrospinal fluid for preclinical or biomarker discovery. Learn More

The biopharmaceutical companies Genmab and Seattle Genetics have expanded their antibody drug conjugate (ADC) pact. Under the new agreement, Genmab has rights to use Seattle Genetics' ADC technology for its development of HuMax-CD74, an antibody in preclinical development to target CD74, which is expressed on a wide range of hematological malignancies and solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a codevelopment and cocommercialization option for any resulting ADC products at the end of Phase I clinical development.

Advertisement:
Quality Tablet Press Replacement Parts Shipped Same Day!
By stocking over 300,000 replacement parts for nearly every press on the market, we’re able to provide quality parts at incredible prices, faster than anyone else in the industry. All Natoli replacement parts are manufactured in the U.S.A. and are available for international delivery – and most items are available with same-day shipping! Request a FREE QUOTE now! http://www.natoli.com/parts

The biopharmaceutical company Gilead Sciences has formed a drug-development agreement with MicroDose Therapeutx for the development and commercialization of MDT-637, MicroDose’s inhalable small-molecule antiviral fusion inhibitor used for the treatment of respiratory syncytial virus (RSV). Under the terms of the agreement, Gilead will pay MicroDose an upfront payment and provide research funding to support MicroDose’s continued development of MDT-637 through Phase IIa clinical trials. Gilead will assume full responsibility for clinical development following Phase IIa. MicroDose could also receive additional payments based on the achievement of certain development, regulatory, and commercial milestones, as well as development fees and royalties on future potential net sales.

Advertisement:
Webcast Auction: May 24 at 11 AM ET.
Featuring processing & packaging equipment from Teva! Lot catalog includes PK 'V' 100 Cubic Foot Blender, Elanco Shionogi Semi Automatic Capsule Filler, Kikusui Libra 36 Station Tablet Press, Marion 30 Cubic Foot Paddle Blender, AMF 340 qt Planetary Mixer and much more. Register & Bid Online at EquipNet.com/Auctions

GlaxoSmithKline (GSK) said it "welcomes" an agreement with the World Health Organization (WHO) on a framework to support global preparedness for a future influenza pandemic. The agreement states that companies supplying vaccines, antivirals, and diagnostics for influenza, will become key stakeholders in the WHO Global Influenza Surveillance Network (GISN), which tracks the development and movement of influenza viruses globally. Industry will increase its financial contribution to the GISN to enable the network’s geographical expansion, and support technical improvements that will accelerate the start of vaccine production, enabling industry to deliver seasonal and pandemic influenza vaccines more quickly.

OncoMed Pharmaceuticals, a company developing stem-cell therapies, has expanded its collaboration with Bayer HealthCare. Bayer’s US affiliate will manufacture clinical supplies of a second Wnt inhibitor in the alliance. Bayer will manufacture the bulk drug substance at its Berkeley, California, clinical manufacturing center to support Phase I clinical testing planned to begin in 2012.

The contract development and manufacturing organization Pharmatek has added spray drying to its drug-formulation and manufacturing capabilities. The company has purchased a Buchi B-290 Mini Spray Dryer for formulation feasibility studies and small-scale clinical manufacturing. This technology can be used for both oral and parenteral dosage forms. In other news, Pharmatek has received approval from the US Drug Enforcement Agency (DEA) for the analysis of Schedules I through V controlled substances, complementing its existing license to develop and manufacture drug products containing Schedules IV and V controlled substances.

sanofi-aventis has signed a multi year research collaboration agreement with the Stanford University Bio-X program that supports, organizes, and facilitates interdisciplinary, collaborative, and innovative research projects in the early phases of development. Under the terms of the agreement, a Stanford Bio-X and sanofi-aventis Joint Steering Committee will fund up to five programs a year. sanofi-aventis may also host postdoctoral fellows at the company, and sanofi-aventis scientists may also be invited by Stanford faculty to be visiting scholars and to pursue research collaborations at Stanford.

The specialty pharmaceutical company Valeant Pharmaceuticals has issued a letter to the shareholders of the biopharmaceutical company Cephalon regarding its bid for Cephalon to state that Valeant is willing to increase its bid of $73 per share modestly. Valeant has issued the letter in connection to the consent solicitation statement process.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com

People Notes

AAIPharma Services, a provider of pharmaceutical product development and manufacturing services, appointed Paul Maffuid as executive vice-president of operations. Maffuid will have responsibility of the company's drug product development services functions.

The biopharmaceutical company Novavax has appointed Louis Fries III, MD as vice-president of clinical and medical affairs, and Jane Halpern, PhD, as vice-president of regulatory affairs. Before joining Novavax, Fries was director of global clinical development at GSK Biologicals, North America. Halpern was previously staff scientist and regulatory affairs specialist at the Vaccine Research Center of the National Institute of Allergy and Infectious Disease (NIAID), in the National Institutes of Health.

PharmTech, the magazine
Current Issue cover
Innovations in Tablet Coating
A technical forum moderated by Angie Drakulich. View this and other articles from our special issue on Solid dosage and Excipients.
Click Here to Read More

Coming soon: The May issue of PharmTech features a special report on over-the-counter drugs and growing standards.

 

 
 

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