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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
Parenteral Packaging
March 13, 2012—March 15, 2012
Berlin, Germany
8th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
March 19, 2012—March 22, 2012
Istanbul, Turkey
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FDA Issues Guidance Agenda for 2012
FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.
GSK and Daiichi Sankyo Launch Vaccine Venture in Japan
GlaxoSmithKline and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in the Asian nation as well as introduce new vaccines.
BI Expands Biomanufacturing Capacity in Europe
Boehringer Ingelheim (BI) has announced the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria. The expansion will include cell-culture and microbial-fermentation capacity, and support cell-line and process-development services for BI’s contract manufacturing business.
SOCMA Issues Support for Generic-Drug User Fees
The Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.
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 Power monitors provide insight into energy use
Two new Allen-Bradley power monitors from Rockwell Automation give manufacturers more data on how, when, and where energy is used in the production process. Although previous technology covered facility and process-level monitoring, the new monitors allow users to go beyond the process level and collect data from specific, energy-intensive applications.
Rockwell's new wireless PowerMonitor W250 uses a self-generating wireless communications platform that is useful for applications such as ceilings or conveyor belts where hard-wired networking is cost-prohibitive. The wireless network transmits data to the Rockwell Software RSEnergyMetrix software. The new PowerMonitor 500, designed for smaller consumption applications, has an on-device LCD display so that operators can access real-time energy demand and consumption data at the machine or process level. The monitor has Modbus TCP and EtherNet/IP communication options and is also integrated with the RSEnergyMetrix software. |
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The FDA has taken the next step in increasing efficiency of electronic regulatory reporting through the implementation of the eMDR Electronic Submissions Gateway. Learn the benefits and best practices of using the FDA's eMDR program to meet specific business needs, and the future of eMDR for Life Science organizations.  Read More
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The CRO Bioanalytical Systems (BASi) plans to restructure its bioanalytical laboratory operations, a move that BASi expects will reduce operating costs by more than $2 million annually. BASi said that it plans to consolidate its laboratory in McMinnville, Oregon, into its 117,000-ft2 headquarters facility in West Lafayette, Indiana. Additionally, the company is evaluating actions to improve the financial performance of its laboratory in Warwickshire, United Kingdom. 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. |
Catalent Pharma Solutions has completed the acquisition, from Gelita, of the remaining 49% minority interest in the R.P. Scherer Eberbach business. After 60 years of joint partnership, Catalent and Gelita agreed that the R.P. Scherer Eberbach business will be better able to serve the growing European pharmaceutical and consumer health softgel market with R.P. Scherer fully integrated into Catalent. Read More
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8 Ways to Reduce Tablet Manufacturing Costs
Are you working with a reduced budget for 2012? Want to learn how to get more and spend less? In an effort to help our customers get the most from their budgets, we put together this valuable list complete with tips, products, and video.  Click here now for access to the exclusive details! |
Celerion, a provider of early-stage drug-development services, and Ricerca Biosciences, a drug-safety assessment expert in harnessing external preclinical innovation, have formed of "The Biosimilars Alliance." The Biosimilars Alliance is focused on preclinical and early clinical assessment of biologics manufactured by a new supplier. It will provide specialized services required to perform early assessment of the viability of a potential biosimilar product. These services include in vitro and in vivo pharmacological assessments of activity and toxicological and immunotoxicological studies. Read More
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Topical Semi-Solid Formulations: CMC Considerations for Stability, Analytical, and Safety Studies.
Live Webcast: Thursday, March 22, 2012 at 1:00 PM EST
Register Free at  http://pharmtech.com/formulations |
The Sanofi subsidiary Genzyme has begun shipping Fabrazyme (agalsidase beta), for treating Fabry's disease, from its newly approved plant in Framingham, Massachusetts. As previously communicated, patients in the United States are now able to return to full dosing in March 2012. In addition, all new patients in the US are eligible to begin Fabrazyme treatment at full dosing levels. In Europe, the process of moving the most severely affected patients to full dose of Fabrazyme will begin in March 2012. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory. Read More
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Overcoming Challenges in Complex Formulation Development: Bilayer Tablets & Beads-in-Capsules.
Live Webcast: Tuesday, April 3, 2012 at 11:00 am EDT, 16:00 GMT
Register Free at  http://www.pharmtech.com/bilayer
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Industry Briefs:
A roundup of additional 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 [email protected] |
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