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Podcasts

Webcast: Overcoming Challenges in Complex Formulation Development: Bilayer Tablets & Beads-in-Capsules
April 3, 2012—Sponsored by Patheon

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)

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

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

World Generic Medicines Congress Europe 2012
February 28, 2012—March 2, 2012
London, United Kingdom

Fundamentals of Lyophilization
March 12, 2012—March 13, 2012
Bethesda, Maryland, USA

Encouraging Development of Therapeutics for Neglected Diseases
March 12, 2012—March 13, 2012
Philadelphia, Pennsylvania, USA

DCAT Week
March 12, 2012—March 15, 2012
New York, New York, USA

More events


FindPharma Search
February 17, 2012 PharmTech.com

News

White House's 2013 Budget Includes FDA Increases
President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.
Click Here to Read More

FDA Releases Draft Guidance on Monitoring Crude Heparin for Quality
FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.
Click Here to Read More

South Africa Plans Joint Venture for New API Plant
The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral medicines.
Click Here to Read More


Product Spotlight

Centrifuge system ensures sample safety and integrity

Thermo Scientific's Sorvall RC BIOS centrifuge system is designed for high-speed, high-volume batch bioprocessing applications. The system integrates a 6-L Fiberlite carbon fiber rotor and 1-L Nalgene bottles to achieve superior yields with faster processing time. The system's applications are designed for bacterial and mammalian cell pelleting, large microbial cultures, and harvesting cell and tissue cultures.

The Sorvall RC BIOS centrifuge system can generate as much as 15,860 × g of separating force, which can reduce cycle times, and also has a power-saving design that reduces overall processing and development costs. In addition, a refrigeration system ensures sample quality, which can help reduce lot-to-lot variability.

The system features an automated lid-lock control that is intended to protect users and samples, and alleviate the opening and closing of the unit. The machine's optional Thermo Scientific Centri-Log data collection software increases quality control, process traceability, and component tracking for cGMP compliance.

Company Notes

The biopharmaceutical company Alexion Pharmaceuticals has completed its $1.1-billion acquisition of 100% of the capital stock of Enobia Pharma, a biopharmaceutical company focused on the development of therapies for treating genetic metabolic disorders. Goldman, Sachs & Co. acted as financial advisor to Alexion. Ropes and Gray LLP acted as lead legal counsel to Alexion, and Cassels Brock & Blackwell LLP acted as Canadian legal counsel to Alexion. Read More

The CDMO Almac has announced that it is doubling its analytical capacity at its 240,000-ft2 North American headquarters in Souderton, Pennsylvania. The facility offers full-service, integrated clinical packaging, drug-supply management, and technology services to pharmaceutical and biotechnology clients. Almac's additional laboratory investment will include polymorph and salt screening, and solid-form development. The new facility is also equipped with a bathless dissolution apparatus for comparative dissolution studies. Read More

Bosch Packaging Technology has announced plans to acquire the machinery business companies of Eisai. Respective agreements were signed on Feb. 8, 2012. Eisai's machinery business specializes in inspection machinery for the pharmaceutical industry. Bosch Packaging Technology and Eisai have agreed to keep the purchase price confidential. The transaction is subject to compliance with antitrust legislation. Read More

Bristol-Myers Squibb has completed its $2.5-billion acquisition of the clinical-stage biotechnology company Inhibitex. The deal was valued at a purchase price of $26.00 per share. As of the expiration of the offer, 77,532,611 shares of common stock of Inhibitex were validly tendered and not withdrawn in the tender offer. As of the close of business on Feb. 10, 2012, approximately 4,260,705 shares remained subject to guaranteed delivery procedures. 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

Takeda Pharmaceutical has announced the establishment of the Takeda Shanghai Development Center (TDSC) within the Shanghai-based Takeda (China) Holdings (TCH), which is a wholly owned subsidiary of Takeda. TDSC will expand the company's clinical-development activities within the Asian region, with a focus on China for general medicine. Read More

Advertisement:
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.

Industry Briefs:

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

Advertisement:
Overcoming Challenges in Complex Formulation Development: Bilayer Tablets & Beads-in-Capsules
LIVE WEBCAST: Tuesday, April 3, 2012 at 11:00 am EDT
Choosing the right formulation for a molecule is a challenging process. Whether you are looking to extend the life cycle of a drug or handling complicated APIs, there are multiple formulation options available for solid dose forms.
Register free at http://www.pharmtech.com/bilayer

 

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

Regulatory Roundup

EMA has released a guideline on how to integrate studying the role of genetic variability between patients during the development of medicines. The guideline, effective August 2012, clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines. The guideline addresses when pharmacogenetic studies should be performed, how these studies should be designed and carried out, how the clinical impact of genetic differences between patients should be evaluated, how dosing or treatment recommendations for genetic subpopulations should be studied, consequences for treatment recommendations and labeling, and the impact of interactions between medicines and of impaired or immature organ function.

The US Pharmacopeia is bringing together regulators, manufacturers, and other stakeholders in global public health for the 11th IPC-USP Science & Standards Symposium on February 22–23 in Mumbai. This year’s Symposium will focus on two important areas for India’s pharmaceutical sector—global quality standards for biologic medicines and supply chain management, according to USP. “The meeting is part of a continuing USP effort with the government of India generally and the IPC specifically to promote access to good quality medicines—not only those being exported but also those intended for the people of India,” says a USP press release on the meeting. For details, visit the USP registration site.

PharmTech, the magazine
Current Issue cover
Strategies for Preferred-Provider Partnerships
by: Patricia Van Arnum
The author examines recent examples of preferred-provider collaborations.
Click Here to Read More

Coming soon: Pharm Tech's March 2012 supplement issue features special solid dosage and excipient coverage.

 

PharmTech Poll

Sterile Manufacturing
During the past decade, what has been the most significant advance in sterile manufacturing?

Vote here
View the poll archive.

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