Top Stories
During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.
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The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.
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INTERPHEX 2016 KEYNOTE SERIES:
SOLID DOSAGE DEVELOPMENT AND MANUFACTURING
Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on innovations in solid dosage development and manufacturing at INTERPHEX 2016.
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Industry News
The agency now allows production of water for injection by non-distillation technologies.
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Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.
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Supplier News
ANGUS reveals ANGUS Life Sciences as a new company division that will serve pharmaceutical, biotechnology, and agriculture markets.
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The merger creates a provider of sample prep, synthesis, and bioanalytical tools for biotherapeutics discovery, development, and manufacturing.
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Bio/Pharma News
The new class of mAbs differs from approved anti-PD 1 mAbs because they do not block the PD-1-PD-L1 interaction.
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Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly 10 years in the position.
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Regulatory News
CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.
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The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.
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FEATURED TOPICS |
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FACILITIES
Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.
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MANUFACTURING
Integrated data and cloud-based solutions can be used for process optimization.
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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 delivery worldwide. By stocking replacement parts, up to 50% less cost than the original equipment manufacturers, Natoli is able to provide the highest quality parts at exceptional prices, faster than anyone else in the industry with next-day service!
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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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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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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 – 4:30 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 live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
Sponsored by BASF
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On Demand
As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.
Sponsored by Capsugel
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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
Umetrics
Australian Centre of Industrial Biotechnology (acib)
Locked4Kids
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Events
April 26-28, 2016
June 6-8, 2016
May 18-19, 2016
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Engineering the Mechanical properties of Amorphous Spray-Dried dispersions
On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
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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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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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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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