Top Stories
The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.
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FDA's breakthrough drug initiative is more popular and successful than ever.
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Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.
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INTERPHEX 2016 KEYNOTE SERIES:
CONTRACT SERVICES MARKET
Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on the contract services market at INTERPHEX 2016.
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Industry News
The Office of Generic Drugs highlights the agency’s work to advance generic drugs.
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The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.
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Supplier News
The new affiliate company will be based in Somerset, New Jersey.
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Through two acquisitions, Recipharm will acquire Kemwell's United States, Swedish, and Indian operations.
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Bio/Pharma News
Linker technology and drug combinations play an important role in the efficacy of ADCs.
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The National Institute of Health will conduct an internal review of the National Cancer Institute's cell manufacturing facilities, which will affect multiple Kite projects.
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Regulatory News
The agency published guidance on data integrity as it is relates to CGMP compliance.
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FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
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REGULATORY WATCH
Global outbreaks energize vaccine R&D and drive production modernization.
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QUALITY
Industry experts and FDA's Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.
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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., maintains a large selection of replacement parts for nearly every tablet press on the market—ready for immediate worldwide delivery. Natoli provides the highest quality parts at exceptional prices, faster than anyone else in the industry. By stocking replacement parts on our premises, we can save our customers up to 50% less cost over the original equipment manufacturers.
 Learn more Natoli. |
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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
Learn more
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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Formulation Development Success Story: Uric Acid Treatment Approved by FDA
A new uric acid treatment that was developed as a partnership between Metrics Contract Services and the project sponsor was recently approved by the FDA. The project came to Metrics six years ago in late Phase I/early Phase II clinical trials. The client was managing multiple changes in the development/clinical timeline and its API and needed a CDMO partner that was technically savvy, collaborative, flexible and reliable.
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Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Experts involved in this work discuss recent initiatives, and offer insights into what must be done to prevent injectables shortages in the future.
Wednesday, April 27, 3:30 – 5:00 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.
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Webcasts
On Demand
Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency's Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.
Sponsored by EtQ
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The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them
LIVE WEBCAST: Thursday, April 21, 2016 at 9 am EDT | 3 pm CEST
 Free registration |
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On Demand
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
Sponsored by AMRI
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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping
On Demand
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on pharmtech tv
Tablet Coating
Blow-Fill-Seal for Aseptic Processes
Cell Therapies
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Events
April 26-28, 2016
June 6-8, 2016
May 18-19, 2016
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Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot Melt Extrusion Process
On Demand
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REFERENCE BOOKS |
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Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
On Demand
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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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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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