Top Stories
Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.
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Sanofi says the program will vaccinate one million students from 6000 public schools in dengue-epidemic regions of the Philippines.
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The conference will take place from May 16–18, 2017 in Philadelphia, Pennsylvania.
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INTERPHEX 2016 KEYNOTE SERIES:
ADDRESSING STERILE MANUFACTURING CHALLENGES
Pharmaceutical Technology and BioPharm International are sponsoring Keynote Series discussions at INTERPHEX 2016 on addressing sterile manufacturing challenges. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
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Industry News
The American College of Rheumatology released a statement encouraging FDA to apply distinct names to biosimilars and maximize clarity in labels.
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The Ethiopian government said it is offering tax and loan incentives to encourage local pharmaceutical production in the country.
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Supplier News
GE Healthcare Life Sciences has expanded production capabilities at its Pasching, Austria facility for sterile liquids.
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Aesica adds development capability at Queenborough with the opening of a new purpose-built facility.
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Bio/Pharma News
FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain's facility in Puerto Rico.
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A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.
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Regulatory News
The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.
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FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.
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FEATURED TOPICS |
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TECHNOLOGY TRANSFER
Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.
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MANUFACTURING
Pharmaceutical Technology spoke with FDA to get the agency's insights on how the industry can ensure quality in solid and semi-solid dosage products.
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PEER-REVIEWED RESEARCH
The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union's current good manufacturing practices.
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SUPPLY CHAIN
Technology is making it easier to stop problems before they can affect patients and the bottom line.
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Pharmaceutical Compliance that Spans the Supply Chain
Today's rise in globalization means that the pharmaceutical market is operating on a grander scale than ever before. Pharmaceutical organizations typically extend manufacturing to suppliers or contract manufacturers, who directly affect the quality of the product.
In this white paper learn about why global harmonization is important in the Pharmaceutical industry and best practices of extending the quality system to the supplier.
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KEYNOTE SERIES AT INTERPHEX 2016
At INTERPHEX 2016, Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series addressing leading bio/pharma industry issues.
In a panel discussion, Industry experts will discuss how technology advances are addressing challenges in biopharmaceutical development including quality control of raw materials, implementation of single-use technologies, process monitoring, and downstream purification.
Tuesday, April 26, 10:15 am to 11:45 am
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Oral solid-dosage forms are the leading drug delivery method, but new development and manufacturing technologies are offering new options for patients. Experts will discuss advances in drop-on-demand manufacturing, polymer thin films for drug delivery, and manufacturing of minitablets.
Tuesday, April 26, 1–3:30 pm
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Natoli Engineering Company, Inc., NP-400 tablet press is a 24/7 workhorse that features built-in controls and off-the-shelf electronics. A self-lubricated turret and upper and lower cams reduce maintenance costs and provide longer operation time. The integral controller is encapsulated in a single footprint design that is ideal for tablet manufacturers who need a reliable, efficient press with the ability to produce 180,000 tablets per hour.
 Learn more Natoli. |
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How will consolidation in the bio/pharmaceutical and contract services market, a changing financial market, and an active political and regulatory year shape the fortunes of the contract services market? In his annual presentation, industry expert Jim Miller will offer his perspectives on the contract services landscape for the next few years.
Wednesday, April 27, 10:30 am – 11:30 am
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Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies.
Wednesday, April 27, 1:30 – 3:15 pm
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The largest, most influential biotech Convention in the world is coming to San Francisco, June 6-9, 2016. Experience powerful business partnering, benefit from invaluable education sessions and network with 15,000+ of biotech's best and brightest. See how the everyday becomes extraordinary — at BIO 2016.
Register now at  convention.bio.org. |
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Webcasts
On Demand
In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed.
Sponsored by Aqua Lab by Decagon
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Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot Melt Extrusion Process
On Demand
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On Demand
Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Sponsored by BASF
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
On Demand
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on pharmtech tv
The Transition from Paper Records to Electronic Batch Records
Addressing Pharma Industry Issues
Biologics Development and Manufacturing Trends
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Events
April 26-28, 2016
June 6-8, 2016
May 18-19, 2016
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Best Practices for Effective Product Transfer
On Demand
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
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