Top Stories
Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.
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Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
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Industry News
USP joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.
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The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.
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Supplier News |
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Label Vision Systems (LVS) will be fully integrated into Microscan and the LVS name will become a brand within Microscan's barcode label verification portfolio.
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Bio/Pharma News
The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.
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Regulatory News
The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.
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Novo Nordisk plans to invest approximately $2 billion over the next five years in new production facilities in Clayton, North Carolina, US and Måløv, Denmark. The facilities are expected to be operational during 2020.
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In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
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FEATURED TOPICS |
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QUALITY
A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
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STANDARDS AND REGULATION
Contract development and manufacturing organizations join forces to address legislative, regulatory, and business concerns in the Pharma & Biopharma Outsourcing Association.
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SUPPLY CHAIN
Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California's were.
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| FORMULATION
Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.
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Training Course - October 15-17 - Basics of Tablet Manufacturing and Troubleshooting;
Learn the basics of tablet shapes and design, tablet press setup & operation, tooling options and steel types, tool inspection, and tool reworking and polishing – with hands-on experience.
This course is designed for tablet compression industry professionals, including tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, research and development, and supervisors.
 Learn more |
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AAPS 2015 Planning Guide
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Catalent provides drug development and delivery solutions to accelerate programs to clinic and market.
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CMIC CMO USA Corporation specializes in the formulation development and GMP commercial manufacturing of solid dosage products.
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One 2 One is a leading global injectable drug product CMO with more than 25 years of experience.
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Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization delivering proven scientific and operational excellence for solid oral dosage forms.
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MPI Research is a full-service CRO that has partnered with Sponsors targeting areas of discovery, safety, clinical, bioanalytical, and analytical sciences, for more than 20 years.
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Agilent AdvanceBio RP-mAb Columns - Resolve mAbs faster and better.
The only reversed-phase column designed specifically for monoclonal antibodies.
Agilent AdvanceBio RP-mAb columns are uniquely engineered for pore size and bonded phase, delivering higher resolution and faster run times and providing accurate, reproducible results when analyzing intact monoclonal antibodies and mAb fragments.
 Join our eSeminar on October 6th and download the AdvanceBio RP-mAb Resources kit. |
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Webcasts
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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Fundamentals of Spray-Dried Dispersion Technology
Live Webcast: Thursday, September 17, 2015 at 15:00 CET | 9:00 am ET
 Register for free |
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On Demand
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by SGS
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Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs
LIVE WEBCAST: Wednesday, September 9, 2015 at 11:00 am EDT, 17:00 CET
Solubility enhancement expert Andreas Gryczke from BASF will share the latest insights into solubility improvement using simple and continuous processing technology twin-screw wet granulation.
 Register for free |
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on pharmtech tv
Needlestick Prevention
Pain in the (Supply) Chain Survey Part 1
Pain in the (Supply) Chain Survey Part 2
Cross-Contamination Risk in Manufacturing of Highly Potent Drugs
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Events
September 28–30, 2015 | Washington, DC, USA
September 28–30, 2015 | Las Vegas, NV, USA
October 25–29, 2015 | Orlando, FL, USA
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Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins
On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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More Reference Library |
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
 Learn more |
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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.
more ebooks |
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