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Chemspec Europe
June 13, 2012–June 14, 2012
Barcelona, Spain
ACHEMA 2012
June 18, 2012–June 21, 2012
Frankfurt, Germany
2012 BIO International Convention
June 18, 2012–June 21, 2012
Boston, Massachusetts
DIA 2012
June 24, 2012–June 28, 2012
Philadelphia, Pennsylvania
IVT's Contamination Control Week
June 25, 2012–June 27, 2012
Boston, Massachusetts
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Takeda Completes Acquisition of URL Pharma
Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.
ISPE Issues Change-Management Guide
New guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.
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Ensure Consistent Compliance
Confidence means using better science for more consistent compliance. Agilent Enterprise Edition uses a direct, automated approach to consistently perform qualification testing, validate calculations, and harmonize reports. Ensure your consistent, cost-effective compliance and reduced regulatory risk with Agilent Enterprise Edition. Visit  www.agilent.com/chem/comply |
USP Issues Change to Viscosity Reference in Monographs
The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity—Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."
Dr. Reddy's and Merck Serono Team Up on Biosimilars
Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.
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Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market.
Learn about pharmaceutical purification, purity, and impurity analyses at
 www.agilent.com/lifesciences/realizepharma |
EMA Pharmacovigilance Legislation to Take Effect; New Q&A Document Offers Practical Guidance to Industry
In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.
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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 |
 Filter assembly for sterile filtration applications
The UltraSnap filter assembly, available from Meissner Filtration Products, secures multiple pre and final filters into a single-use filtration system for plug-and-play use. The system is optimized for sterile filtration applications and effectively makes the scale of single-use filters unlimited, as it offers maximum flexibility to accommodate processing requirements for flow capacity, throughput volume and retention efficiencies. In addition, the UltraSnap assembly eliminates the time and expense associated with the changeout of filters in stainless-steel housings and their associated cleaning and reassembly. With a very low hold-up volume, the system minimizes product loss during changeouts and ensures maximum product recovery. Support stands and carts can also be designed to integrate the filter assembly into unit operations. The UltraSnap filter assembly is flexible by design and can incorporate UltraCap H.D. filter capsules from 10 to 50 in. to maximize processing and scale-up possibilities.
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IMPORTFAB is a well-established contract manufacturer, specializing in the manufacturing and packaging of semi-solid and
liquid products. Our objective is to maintain our position as a reliable reference point in the manufacturing of quality pharmaceutical products: essentially, a benchmark for modern, efficient production, assured through the use of highly performing equipment. IMPORTFAB is cGMP compliant by the FDA and Health Canada.  http://www.importfab.com |
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Boehringer Ingelheim has established a new EUR 50-million+ ($62.2 million+) pilot-plant facility for the production of newly developed APIs in Biberach, Germany. The new technical center will have a useable area of approximately 2700-m2 (29062.56 ft2) and will host four manufacturing bays including four synthesis laboratories, which will handle the transfer of processes from laboratory to technical scale. The facility will have 15 chemical reactors with volumes of 100 to 300 liters, and is scheduled for completion in early 2014. Read More
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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 |
Catalent Pharma Solutions has completed construction of its newly renovated 3300-ft2 aseptic fill–finish manufacturing facility at Research Triangle Park, North Carolina. The product-development group conducts preformulation, formulation development, process development, and manufacturing support in addition to offering analytical development and stability capabilities. The sterile clinical manufacturing suite will provide Class A manufacturing space containing a flexible aseptic vial-filling line capable of producing Phase I and Phase II clinical-trial materials. These fill–finish facilities are designed to comply with global GMP requirements. Read More
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Rapid Micro Biosystems is pleased to announce the 2013 availability of two new applications leveraging the Growth Direct™ technology. The Growth Direct™ Systems for Environmental Monitoring and Sterility Testing provide automated, non-destructive, rapid analysis and detection based on proven technology. Sample preparation mirrors the existing steps with positive results in hours and final reporting in half the time of traditional methods
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Eli Lilly has officially opened the Lilly China Research and Development Center (LCRDC) in Shanghai. The goal of the LCRDC is to discover diabetes medicines with mechanisms of action that can be tailored specifically for the Chinese population to delay the progression of the disease. Read More
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Ropack, provider of solid dose contract packaging services, celebrates its 35th anniversary by expanding its production campus to nearly 250,000 sq. ft. The fully licensed site adds 36,000 sq. ft. of validated ambient and cold storage warehousing as well as five new Class 100000 clean rooms – bringing Ropack's total clean rooms to 32 – to accommodate increasing customer needs. Contact: Paul Dupont, [email protected]  www.ropack.com |
Siegfried has acquired Alliance Medical Products (AMP), a sterile manufacturer, for $58 million. The purchase price specifies a contingent earn-out consideration subject to AMP meeting defined profitability goals for the fiscal year ended Dec. 31, 2013. Read More
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Come to the BIO International Convention, June 18-21, 2012, Boston, Mass., for the connections, partnerships and innovations to get business done. Join 15,000+ biotech leaders for a BIO Program offering perspectives on issues and a BIO Exhibition with 1,800+ companies showcasing the latest technologies and services. BIO One-on-One Partnering™ makes it easy to set up face-to-face meetings in the BIO Business Forum and the BIO Exhibition  http://convention.bio.org |
Industry Briefs:
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
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When Softgels Are a Good First Option: Overcoming Bioavailability Challenges
Live Webcast: Tuesday, June 12, 2012 at 11:00 am ET
Register Free at  http://www.pharmtech.com/softgels |
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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Screening Methods for Elemental Impurities: New Regulatory Expectations Event
Date: June 14, 2012 at 11:00 AM EDT for North America and on June 21, 2012 at 11:00 AM CET for Europe
Register Free at  http://www.pharmtech.com/metals |
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| A More Rational Approach for Sterile Product Manufacturing |
by: James E. Akers, James P. Agalloco
The authors assert that the current gulf between aseptic processing and terminal sterilization can be bridged by re-examining fundamental regulatory philosophies for sterile-product manufacturing.
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Coming soon: Pharm Tech will be celebrating its 35th Anniversary in our July issue. Don't miss a special section on breakthroughs and emerging technologies in manufacturing. |
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Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
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