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Featured Articles
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Manage Lyophilization: How Dry Is Dry Enough?
By Baxter Healthcare Corporation -- BioPharma Solutions
Management of medication delivery through lyophilization — freeze-drying — is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins, and monoclonal antibodies, must be lyophilized, as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms.
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An Efficient Synthesis Of Methyl 2-Methoxy-4-Amino-5-Chloro-Benzoate-(Carbonyl-14C)
By Analytical Bio-Chemistry Laboratories (ABC)
Methyl 2-Methoxy-4-Amino-5-Chloro-Benzoate-[Carbonyl-14C] (MMACB-14C) is an important intermediate in the synthesis of several Carbon-14 labeled APIs. Compound 1 was needed as an intermediate for a synthesis that required seven additional steps that resulted in an overall yield of 36%. A better route was required to make the synthesis more efficient.
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Controlled Drug Handling
By Aptuit, Inc.
A mid-size pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. Aptuit's client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator.
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Bulletin Board
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Webinar: Thermal Stability And Aggregation Analysis — Clues To Better Protein Formulations
Thursday, January 26, 2012 | 8:00 AM PST | 11:00 AM EST
This educational webinar will offer deeper insight into the mechanisms leading to protein stability/instability. The presenters will discuss the use of intrinsic fluorescence combined with static light scattering in analyzing the stability characteristics of a protein during the initial screening process and subsequent formulation. Register now.
Webinar: Real-Time Scheduling Of Biomanufacturing Operations
Thursday, January 26, 2012 | 3:00 PM GMT | 4:00 PM CET
This webinar will show how today's leading biomanufacturers achieve real-time scheduling using a revolutionary new approach. This scheduling system "understands" the complexity of biomanufacturing operations, "knows" how long steps in the process actually take, and incorporates variability, limited resources, and complex interdependencies, all in real-time. Register now.
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Spotlight On High-Potency Manufacturing
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| Case Study: Building Safety Into Isolator Controls Systems |
| As isolators become more customized to meet the requirements of specific pharmaceutical processes, the controls systems have been challenged to provide more safety and flexibility.
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| White Paper: Integrating Isolation With Filling Systems |
| Remaining competitive in pharmaceutical development and production can be a challenge as it becomes more complicated to get products through clinical trails and eventually produce them. To remain competitive, pharmaceutical companies need to develop products faster and more cost-effectively.
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| Case Study: Implementing A Proactive Approach To Preventing Secondary Dust Explosions |
| Under intense scrutiny since the U.S. Chemical Safety and Hazard Investigation Board (CSB) released its 2006 Combustible Dust Hazard Study, OSHA is taking action to amend its General Industry Housekeeping provision, 1910.22. The amendment to the housekeeping requirements comes as a result of employers' misinterpretation of housekeeping standards already included in the provision.
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| Isolation Technology: Current Trends And Challenges |
| In this Q&A, Comecer's Emiliano Spagnolo discusses the biggest isolation-related issues currently facing the pharmaceutical industry — and explains how the latest generation of isolation technology is helping manufacturers overcome these problems.
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| Application Note: Avoiding Dust Explosions |
| Dusts may be generated in any part of any production process. Explosions can occur within any process where a combustible dust accumulates, is produced or stored, is airborne, and can be triggered by a variety of energy sources. The severity of a dust explosion is related to the heat released in the combustion of the materials.
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| Brochure: HATA CVX Series Tablet Press |
| The HATA CVX Series provides easy access for maintenance, turret and parts removal, and complete manual wash-in-place cleaning. An easy-clean design features locking pins and thumb screws for a quick and easy, no tools disassembly.
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| Browse the download library |
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Industry Event
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| InformexUSA |
| February 14 to 17, 2012 | New Orleans, LA
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