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Featured Focus: Solid Dose |
QbD Validation Strategies:
The Process Design Phase Part 1 |
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By Anil Doshi, R.Ph., Ph.D, President, Infinity Pharmaceutical Consulting
Process validation comprises three stages that take place over the life cycle of the pharmaceutical drug product. Stage 1, which will be the focus of this column, is referred to as process design, and encompasses pharmaceutical drug products in early development. |
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ARTICLE: Addressing Solubility Challenges With Mesoporous Silica |
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By Michiel Van Speybroeck, Ph.D., R&D Director, Formac Pharmaceuticals
It is estimated that around 70% to 90% of new chemical entities in discovery pipelines, and 40% of drugs on the market, are poorly soluble in water. Poor aqueous solubility may drastically limit oral bioavailability and ultimately compromise therapeutic outcome. It is becoming increasingly apparent that the adsorption of poorly water soluble drugs on mesoporous silica materials is a very effective way to address this solubility problem. |
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APPLICATION NOTE: Solid Dosage Form Manufacture Via Twin Screw Extrusion |
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WHITE PAPER: LIF Sensors vs. NIR Sensors White Paper |
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CASE STUDY: A Case Study In Sizing Nanoparticles |
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PRODUCT: Checkweigher And Metal Detector System |
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NEWS: FDA Approves First Drug In a Decade To Prevent Organ Rejection In Liver Transplants |
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» Packaging |
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ARTICLE: Trends And Concerns Of The Pharmaceutical Packaging Industry |
By Chris MacKinnon, Life Science Leader
What do we do with the packaging on the products we buy? We throw them away, right? But if you consider past the idea that it's "just recyclable material," it's evident that packaging plays an essential role. When it comes to the pharmaceutical industry in particular, this couldn't be closer to the truth. |
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VIDEO: MAC Blister Packaging Machine |
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BROCHURE: DesiMax Desiccant Labels |
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PRODUCT: X-Ray Inspection Systems: Cartons Or Cases |
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PRODUCT: Contract Pouch And Sachet Filling |
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PRODUCT: Blister Folding Machine For Double Blisters |
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» Liquid Dose |
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ARTICLE: Integration Of A Single-Use Platform Process Within An Innovative Facility Design |
By R. Barry Holtz, Ph.D., President, G-Con Manufacturing, LLC, and Dennis Powers, Director, Integrated Solutions North America, Sartorius Stedim North America, Inc.
With the age of the blockbuster drug passing, the business model for the biopharmaceutical industry is changing. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability will be implemented. |
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APPLICATION NOTE: A Review Of The Practices Of Using Carbon In The Production Of Fine Chemicals |
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GUIDE: The Aqueous Cleaning Handbook |
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PRODUCT: UltraSnap Filter Assembly |
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PRODUCT: Custom Liquid Filling Equipment |
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NEWS: Peregrine Pharmaceuticals Updates Top-Line Data From Phase II Clinical Trial Of Bavituximab In Second-Line Non-Small Cell Lung Cancer |
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» Inspection |
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PRODUCT: Visual Tablet Inspection System: PAPPIS |
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PRODUCT: High-Voltage Leak Tester |
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PRODUCT: X-Ray Inspection Of Pharmaceutical Capsules |
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PRODUCT: Tablet/Capsule Counting Inspection System: SureCount |
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PRODUCT: SolidsFlow Vibratory Feeders |
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NEWS: Eriez E-Z Tec XR-Bulk X-Ray Inspection Systems Provide Protection For Bulk Flow Applications |
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» QA/QC |
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ARTICLE: Bad Quality Is Contagious: Stop Before It Spreads |
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By Rosario Quintero-Vives, Sr. Regulatory And Compliance Specialist, RQV Consulting
Disregarding the rules in the regulated industry is like a contagious disease. If you don't control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease. When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized. |
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ARTICLE: Preparing For A Successful FDA Inspection |
By Peter Müller, Ph.D., CARBOGEN AMCIS AG
Routine inspections by the U.S. FDA are just as important for non-U.S. pharmaceutical manufacturers as they are for U.S.-based companies. This is especially true for Swiss companies, which export a great share of their products to the United States. |
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WHITE PAPER: When To Replace Your Biological Safety Cabinet |
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VIDEO: Portable Density Meter: DMA 35 From Anton Paar |
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PRODUCT: Pharmaceutical Air Quality Monitoring |
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PRODUCT: Pharmaceutical Contract Packaging: Quality And Technologies |
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NEWS: Dako Receives FDA Approval For Fast, Accurate, Nontoxic FISH Assay For Cancer Diagnostics |
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» Logistics |
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CASE STUDY: Orthofix Relies On FedEx To Help Manage Its Inventory |
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BROCHURE: Pharmaceutical Bins |
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PRODUCT: Bag-In-Box Liquid Liners For Bulk Containers |
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PRODUCT: Pharmaceutical Contract Packaging: Quality And Technologies |
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NEWS: Pharmaceutical Distribution Security Alliance Applauds IOM Call For A National Supply Chain Solution |
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» Critical Environments |
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ARTICLE: The Benefits Of Machine Washing Laboratory Glassware vs Hand Washing |
By Lisa Choplo, Miele Professional
Hand washing not only presents inherent safety risks for employees, but is also not a repeatable process and produces variable results. Automating the washing process is one step that can be taken to modernize the laboratory and make it a safer and greener work environment. |
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WHITE PAPER: What You Should Know About Pharmaceutical Cleaning Validation |
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CATALOG: Hoods And Lab Equipment |
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BROCHURE: ANATEL TOC600 On-Line Total Organic Carbon Analyzer Brochure |
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PRODUCT: Canopy Hoods |
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