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DIA 2012
June 24, 2012–June 28, 2012
Philadelphia, Pennsylvania
IVT's Contamination Control Week
June 25, 2012–June 27, 2012
Boston, Massachusetts
CPhI China
June 26, 2012–June 28, 2012
Shanghai, China
2nd Infectious Diseases World Summit
July 9, 2012–July 10, 2012
San Francisco, California
Orphan Drug Summit
July 24, 2012–July 26, 2012
London, United Kingdom 
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 Workstations designed for sterile environments
Pepperl+Fuchs's human machine interface (HMI) solutions are designed for pharmaceutical processing. The Aseptic Operator Workstation features a flush, 316-L stainless steel faceplate, ergonomically-angled, antimicrobial keyboard, and an industrial-grade monitor with FDA-grade silicone gasket for use in sterile pharmaceutical environments. The gasket replaces the traditional silicon caulking, thus reducing installation time and eliminating the 24-h curing period. The workstation is compatible with standard maintenance procedures for cleaning solutions and for spray and wipe functions. If a component requires adjustment, there is no caulk to remove and replace, which reduces downtime by at least 24 h. The units are suitable for use in general purpose and Class I, Division 2 classified areas, satisfy Class 100 (ISO 5) requirements, and are Grade A/B compatible. The VisuNet GMP workstation complies with GMP requirements for optimal cleanability, chemical resistance, no abrasion of materials, and antibacterial keyboards, and is suitable for cleanroom use.
The PowerScan D Cabled Barcode Reader System is now certified for use in Class I/II/III, Division 2 hazardous locations and in Zone 1 and Class I/II/III, Division 1 hazardous areas. It reliably reads all common 1D-barcode types, can capture damaged and difficult-to-read barcodes, and operates in hazardous areas under harsh conditions.
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Fujifilm Diosynth Biotechnologies is increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell-line development and process development, and the addition of a new multiproduct cGMP facility at its Billingham, United Kingdom, site. The first phase has included development of the company’s cell line and process/analytical development facilities, including the addition of high-throughput technologies. The company has begun construction on a cGMP cell bank and a 1000-L biologics manufacturing facility on the Billingham site. This facility will be based upon single-use technology for both upstream and downstream operations. The cell-bank manufacturing facility will be available in the second quarter of 2013, and the mammalian cell culture facility is expected to be operational in the second half. Read More
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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 |
GlaxoSmithKline (GSK) is continuing to tender its offer to acquire all outstanding shares of Human Genome Sciences (HGS). GSK also notes the newly announced date of July 16, 2012, for submission of definitive acquisition proposals. GSK continues to believe that participation in the process is unnecessary given the company’s offer is not conditioned on due diligence or financing and can be completed expeditiously. GSK has therefore today sent a letter on June 15, 2012, to HGS declining again to participate in this process. GSK’s offer to acquire all of the outstanding shares of HGS for $13.00 per share in cash represents a premium of 81% to HGS’s closing share price of $7.17 on Apr. 18, 2012, the last trading day before HGS publicly disclosed GSK’s private offer. 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, paul.dupont@ropack.com  http://www.ropack.com |
The US District Court for the District of New Jersey has ruled against Merck & Co. in a patent infringement suit against Apotex involving Nasonex (mometasone furoate monohydrate). The patent at issue in this case is US Patent No. 6,127,353 that covers mometasone furoate monohydrate, the active ingredient in NASONEX and which provides exclusivity for this form of mometasone until Apr. 3, 2018. Apotex is seeking FDA approval to sell a generic version of Nasonex. Read More
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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 |
Pfizer has received a Complete Response Letter from FDA in regards to its new drug application (NDA) for tafamidis meglumine. FDA is requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The agency has also asked for additional information on the data within the current tafamidis NDA. Pfizer plans to work with the FDA to address the content of the letter. Tafamidis is an investigational medication for treating transthyretin familial amyloid polyneuropathy in adult patients with symptomatic polyneuropathy to delay neurologic impairment. Read More
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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 |
The CDMO Vetter Pharma International is building a new filling line for syringes at its Ravensburg Vetter South (Germany) location. The line can handle batches of up to 1 million units per day and is especially designed for the aseptic filling of high-volume products, such as vaccines. The company is also expanding its services for the early clinical phases of new drugs at its Vetter Development Service locations in Chicago, Illinois, and Ravensburg (Germany). Read More
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Intensive Look at the Pharmaceutical Supply Chain: Good Distribution Practices
Join CfPA and supply chain stakeholders on July 24-25 for an intensive course on effective solutions for delivering temperature controlled life science products globally. Using current regulatory agency regulation, guidance and pharmacopeia chapters from around the world, we will cover best practices to ensure that drug products reach the end user with their quality intact.  Read more |
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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On Demand Webcast:
Better treatments, improved bioavailability This 90-minute webcast will examine advances in lipid-based drug delivery systems (LBDDS) for enhancing the bioavailability of absorption-limited small and large molecules. Register free at  www.pharmtech.com/lipid |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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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 |
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| Preclinical Dose-Formulation Stability |
by: Amy Smith, Melissa Whitsel
When designing stability protocols, formulation, storage, and dosing conditions must be assessed.
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Coming soon: Don't miss our small-molecule GMP coverage in Pharm Tech's July issue. |
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Participate in the Pharmaceutical Technology–PharmSource Annual Outsourcing Survey
Is your company increasing its level of outsourcing? How do CMOs and CRO see the market for contract services? Let your opinion be heard. Take the Pharmaceutical Technology–PharmSource Annual Outsourcing Survey
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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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