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Podcasts

Webcast: A Quality by Design (QbD) Approach to Monoclonal Antibodies Formulation and Lyophilization Process Development
March 14, 2012—Sponsored by Patheon

Webcast: Increasing Laboratory Efficiency and Savings with the ACQUITY UPSFC System
Sponsored by Waters Corporation (On Demand)

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)

MORE WEBCASTS

Podcast: Process Validation for Sterile Manufacturing (Cook Pharmica)

Podcast: Pharmaceutical Forensics for Identification and Source Determination of Particulate Contamination in a Parenteral Manufacturing Process (Gateway Analytical)

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

Podcast: Technical Perspectives: Antibody Drug Conjugates (SAFC)

MORE POCASTS

Events

Pharmaceutical Parallel Trade
February 6, 2012—February 7, 2012
London, United Kingdom

Global ManuCHEM Strategies 2012
February 13, 2012—February 14, 2012
Berlin, Germany

Informex
February 14, 2012—February 17, 2012
New Orleans, LA, USA

Pharmapack
February 15, 2012—February 16, 2012
Paris, France

Cancer Biologics
February 21, 2012—February 23, 2012
San Francisco, CA, USA

More events


FindPharma Search
February 2, 2012 PharmTech.com

News

FDA Files Consent Decree Against Ranbaxy
The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.
Click Here to Read More

Pharma Targets Tropical Diseases
Pfizer, Sanofi, GlaxoSmithKline and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the US, UK, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities.
Click Here to Read More

Pfizer's 2011 Financial Information Shows Overall Increase
Pfizer announced a decrease in fourth-quarter revenues, but a slight increase in full-year 2011 revenues in its financial report on Jan. 31, 2012.
Click Here to Read More

PhRMA Transitions Management of its Benefit–Risk Action Team
PhRMA announced that it will transition the management of its benefit–risk action team to the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters.
Click Here to Read More


Product Spotlight

Extrusion and calendering line forms tablets accurately

Bosch Packaging Technology’s integrated melt-extrusion and calendering line features a continuous production process for pharmaceutical substances, and meets all GMP standards. Its modular structure enables manufacturers to customize extrusion and forming equipment. Its capabilities feature direct shaping of pills or oblong shapes, in addition to pelletizing with its granulation-head technology. The products can be used for customized scale-ups and are designed for contained or noncontained environments.

The line includes the Pharma Extruder WCF 0040PH, which continually processes the substrate with active ingredients through the melting, mixing, kneading, aerating, tempering, and forming stages. Also included is the Pharma Calender BPK 0050, which is designed to ensure accurate forming of tablets by using dual rollers with forming cavities.

Company Notes

Amgen has agreed to acquire the biotechnology company Micromet for approximately $1.16 billion ($11 per share in cash). The transaction was unanimously approved by both companies' boards of directors and includes blinatumomab, a bispecific T-cell engager (BiTE) antibody in Phase II clinical development for treating acute lymphoblastic leukemia and non-Hodgkin's lymphoma, as well as proprietary BiTE antibody technology. Read More

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

Catalent Pharma Solutions has expanded its controlled-release drug-development and supply capabilities at its Schorndorf, Germany, facility. The expansion includes the addition of R&D and commercial-scale fluid–bed technology, OptiMelt hot-melt extrusion capabilities, and additional cGMP compliance for handling OEB Class III customer products. Read More

Advertisement:
Brabender® Pharma USA, Inc. is an innovative company specializing in the manufacturing of twin-screw extruders for HME applications. The effort has been to concentrate on the finest quality equipment to produce small batch sizes up to production scale processes. The 12mm Mini-Compounder is ideally suited to this undertaking while other models offer options to achieve production capacity. For further details on the Mini-Compounder Click Here.

Celgene, a biopharmaceutical company, has agreed to acquire the clinical-stage biotechnology company Avila Therapeutics for up to $925 million. The acquisition provides Celgene with Avila's AVL-292, a highly selective Bruton's tyrosine kinase (Btk) inhibitor for treating hematologic cancers, currently in Phase I clinical development. In addition, Avila's proprietary Avilomics platform, which is used to produce covalent drugs that achieve protein silencing. Read More

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Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.
 

Kerry Ingredients & Flavors, a provider of functional ingredients, is investing $10 million in expanding its Beloit, Wisconsin, facility to include a cell-science laboratory. The expansion will feature a consumer nutrition center, flavor laboratories, and product ideation and customer collaboration suites. The project is expected to be complete by August 2012, and will add an additional 30,000 ft2 to the existing 260,000-ft2 facility. Read More

Advertisement:
North America’s largest chemical trade show, is an all encompassing global chemical event featuring a trade show floor, conference sessions, and networking receptions. This premier annual event will bring together motivated buyers and sellers in the fine, specialty and custom chemical industry for 3 days from February 15-17, 2012 at the Morial Convention Center in New Orleans, LA. Informex will provide numerous opportunities to make new connections, firm up projects with existing suppliers/clients, and learn about the latest trends in the chemical industry. Register today!
  

Teva Pharmaceutical Industries's subsidiary Cephalon has issued a voluntary recall of Treanda (bendamustine hydrochloride) for injection (25mg/8mL), lot TB30111), for treating indolent B-cell non-Hodgkin's lymphoma, after glass fragments were discovered in a single vial. The affected Treanda lot is packaged in 8-mL vials and was distributed to wholesalers and distributors nationwide between Mar. 22, 2011, and Oct. 5, 2011. Read More

Advertisement:
INTERPHEX™ New York May 1-3, 2012 - Javits Convention Center - New York, NY INTERPHEX™ is the leading annual pharmaceutical and biopharmaceutical trade show. Key decision makers find the networking opportunities, products, services and information they need to ensure quality and maximize efficiency, agility, and flexibility that solve manufacturing and supply chain problems. Find out more at http://www.interphex.com/AT.
  

A roundup of other company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More

 

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

PharmTech, the magazine
Current Issue cover
Inside USP: Global Harmonization Presents Opportunities and Challenges
by: Anthony J. DeStefano, PhD, Kevin Moore
To keep moving forward, the Pharmacopoeial Discussion Group needs industry participation.
Click Here to Read More

Coming soon: Don't miss our formulation coverage in the March 2012 issue of Pharm Tech.


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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