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Podcasts

Webcast: Increasing Laboratory Efficiency and Savings with the ACQUITY UPSFC System
January 24, 2012—Sponsored by Waters Corporation

Webcast: Optimizing Topical Drug Development and Manufacturing
Sponsored by DPT (On Demand)

Webcast: Industry Experts on the Design and Performance of Oral Osmotic Technology
Sponsored by Colorcon (On Demand)

Webcast: Cell-Line Development for Biomanufacturing: Considerations for Optimizing Mammalian Cell Lines
Sponsored by Mirus Bio (On Demand)

Podcast: Baseline Guide Risk-based Manufacture of Pharmaceutical Products (Risk-MaPP) – Approach and Experience (OSO BioPharmaceuticals)

Podcast: Technical Perspectives: Antibody Drug Conjugates (SAFC)

Podcast: Pfizer Outlines its Supply Strategy

Podcast: Perspectives from CPhI Worldwide
PharmTech's Patricia Van Arnum discusses strategies in optimizing API syntheses and manufacturing with experts from Aptuit, Cambridge Major Laboratories, and UBM.

Events

Fourth Annual Optimizing Biologics Formulation Development
January 9, 2012—January 10, 2012
San Diego, CA, USA

CHI PepTalk 2012
January 9, 2012—January 13, 2012
San Diego, CA, USA

European Pre-Filled Syringes
January 18, 2012—January 19, 2012
London, United Kingdom

Latin America: Regulatory Compliance Requirements for Life Science Products
(Focus: Brazil, Mexico, Argentina)
January 19, 2012—January 20, 2012
San Francisco, CA, USA

Enhancing Drug Bioavailability & Solubility
January 25, 2012—January 26, 2012
Boston, MA, USA

More events


FindPharma Search
December 22, 2011 PharmTech.com

News

HHS and Novartis Dedicate First Cell-Based Flu Vaccine Plant in US
Last week, the US Department of Health and Human Services and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs.
Click Here to Read More

GAO Recommends Strengthening FDA's Ability to Respond to Shortages
The Government Accountability Office issued a report recommending that FDA's ability to respond to drug shortages be strengthened. The report was released in conjunction with a Senate hearing before the Committee on Health, Education, Labor, and Pensions on Dec. 15, 2011, on the subject of drug shortages.
Click Here to Read More

GPhA Proposes Voluntary Initiative to Address Drug Shortages
The Generic Pharmaceutical Association has proposed a multistakeholder initiative to minimize current and future critical drug shortages. The announcement follows a series of Congressional, executive, and industry responses to address the recent problem of drug shortages.
Click Here to Read More

EMA Plans 2012 Workload
EMA has unveiled its work program for 2012, which forecasts a slight increase in marketing authorization applications for new medicines compared with 2011. In addition, EMA said that it will, where needed, strengthen the quality, regulatory, and scientific consistency of its assessment process.
Click Here to Read More


Product Spotlight

Single-use bioreactors for mammalian cell-culture applications

EMD Millipore’s Mobius CellReady 200-L bioreactor is designed to expedite the process of bringing biological drugs to market. The machine integrates several features that are intended for ease of use, reliability, and operational flexibility. The bioreactor’s hardware includes on-board automation, which provides an ergonomic operator interface.

The Mobius SensorReady technology offers the flexibility to configure process monitoring at the point of use, thus reducing the need to customize bioreactor process containers and enabling easy integration of new sensor technologies. The rigid base and top panel feature of the bioreactor process container are designed to facilitate installation. The system is available as a complete, turn-key system or as a modular system to integrate with the platform of choice.

Company Notes

Amgen and the generic-drug pharmaceutical company Watson Pharmaceuticals have announced a collaboration to develop and commercialize, on a worldwide basis, several oncology antibody biosimilar medicines. Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products. Watson will contribute up to $400 million in codevelopment costs over the course of development, including the provision of development support, and will share product development risks. In addition, Watson will contribute its expertise in the commercialization and the marketing of the products. The collaboration products are expected to be sold under a joint Amgen–Watson label. Watson will initially receive royalties and sales milestones from product revenues. The collaboration will not pursue biosimilars of Amgen’s proprietary products.

Advertisement:
Introducing Waters ACQUITY UPSFC System −The world's first UPLC-based system for SFC. This normal phase chromatographic solution uses CO2 as the main mobile phase−reducing solvent and increasing opportunities. Now you can run normal phase chiral and achiral applications with superior sensitivity, resolution, and speed. waters.com/upsfc

Boehringer Ingelheim has announced its plans to invest EUR 70 million ($91 million) to expand its manufacturing plant in the Zhangjiang High-Tech Park in Shanghai into a supply center for China. The goal of this project is to bring more health to more patients and to continuously improve Boehringer Ingelheim’s product competitiveness and enlarge its market share.

Advertisement:
Powerful Solutions for Any HPLC Environment
Utilizing the modular nature of its Prominence HPLC/UFLC and Nexera UHPLC systems, Shimadzu can build a system designed to address your specific application. From conventional, multidimensional and high temperature LC to preparative, ultrafast and high resolution, Shimadzu systems deliver superior data quality, speed, reproducibility, resolution, robustness, and versatility. Learn more.

ImmunoGen has entered into an antibody-drug conjugate (ADC) collaboration with Eli Lilly. Under this agreement, Lilly will pay an upfront fee of $20 million for rights to take a limited number of exclusive licenses to use ImmunoGen’s maytansinoid targeted antibody payload technology with Lilly monoclonal antibodies to develop ADC anticancer therapeutics. Each license taken entitles ImmunoGen to receive milestone payments potentially totaling approximately $200 million and also royalties on the sales of any resulting products. ImmunoGen also is entitled to receive financial compensation for any research and/or manufacturing done on behalf of Lilly. Lilly is responsible for the development, manufacturing, and marketing of any products resulting from this agreement.

Advertisement:
At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash. http://www.solvaychemicals.us/EN/markets/Markets.aspx

Sanofi has completed the divestiture of its dermatology business, Dermik, to Valeant Pharmaceuticals, a specialty pharmaceutical company, for a total cash consideration of $422.5 million. The scope of the transaction includes Dermik assets, which consist of an aesthetic and therapeutic business in the United States and Canada, as well as an aesthetic business around the world. Also included in the transaction is Sanofi’s Laval, Canada, site, which includes Dermik’s manufacturing facility.

Advertisement:
Increasing Laboratory Efficiency and Savings with the ACQUITY UPSFCTM System
LIVE WEBCAST: Tuesday, January 24, 2012 at 11:00 AM EST

This webcast will outline the features, benefits, business impact of the ACQUITY UPSFC System, highlight the business benefits of converting a normal phase LC USP compendia to a UPSFC™ method, and review the efficiency and utilization when paired with MS. Register Free at http://chromatographyonline.com/labefficiency

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 services, has appointed Kevin Flanagan as vice-president of packaging services. He will oversee the company’s packaging and distribution functions at the Wilmington, North Carolina headquarters.

Kevin W. Sharer, chairman and CEO of Amgen since 2000, has announced his plan to retire from the company at the end of 2012. As part of the transitional process, Sharer will step down as CEO, effective May 23, 2012, and remain as chairman of the company’s board of directors until Dec. 31, 2012, at which time he will retire from the board and from the company. Robert Bradway, currently president and chief operating officer, will become CEO on May 23, 2012. The board is planning to elect Bradway as its chairman Sharer retires from that position at the end of 2012. The board will also elect a lead independent director at that time.

Roche has appointed Sophie Kornowski-Bonnet, currently general manager of Roche Pharma in France, as head of Roche Partnering, effective Feb. 1, 2012, and concurrently will join Roche’s enlarged corporate executive committee. She will report to Severin Schwan, CEO of the Roche Group. She will relocate to Roche’s headquarters in Basel, Switzerland, and succeed Dan Zabrowski, who will take over the position as head of Roche Applied Science in the diagnostics division, located in Penzberg, Germany, as of Feb. 1, 2012. Zabrowski will be a member of the diagnostics leadership team and report to Daniel O’Day, chief operating officer of Roche Diagnostics.

PharmTech, the magazine
Current Issue cover
The Development of a Floating Drug-Delivery System for Metronidazole
by: Shamsuddin Sultan Khan, Mesbah Uddin Talukder
The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
Click Here to Read More

Coming soon: Pharm Tech's January 2012 issue will highlight advances in small-molecule synthesis.

Participate in 9th annual bio-industry study
We hope you will take part in one of the bio industry’s most authoritative, comprehensive analyses. Participants will receive a free summary of the global results, and for each completed survey, BioPlan Associates will donate $10 (up to $10,000) to global health charities. The survey takes between 10–25 minutes, depending on your areas of expertise.

 

 

 

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