|REGULATORY WATCH|

New Drugs and New Initiatives Shaped 2015

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.
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|SEMISOLIDS QUALITY|

Optimizing Semisolid Dosage Forms

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.
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|ROOM PRESSURIZATION|

Preventing Room Pressurization Failures

All openings and potential breaches for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.
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|GLOBAL MARKET REPORT|

Market Access Outlook for Canada

The author provides an overview of the key aspects of the current Canadian pharmaceutical market.
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|API SYNTHESIS & MANUFACTURING|

Outlook Bright for Branded and Generic Active Ingredients

A strong API market is expected in 2016 despite fewer new drug approvals.
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|TROUBLESHOOTING|

Determining Biosimilarity

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes for determining biosimilarity.
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|OUTSOURCING OUTLOOK|

CMO Investors Have More Money Than Places to Spend It

CMO industry consolidation may be frustrated by a dearth of attractive assets.
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|ASK THE EXPERT|

Crafting Standard Operating Procedures

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.
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|VIEWPOINT|

The Search for Job Satisfaction

Employers have work to do to improve job satisfaction and retain qualified workers.
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|Webcasts|

Thermal Sintering for Controlled Drug Release of Hydrophilic Drugs

On Demand
Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled. Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with thermal sintering. This approach intensifies the retardation of drug release by forming plastic matrices of high mechanical strength, which can withstand dose dumping and achieve controlled release. In this webcast, a formulation expert will discuss BASF's Kolliwax grades and their suitability for thermal sintering; describe how high-dose hydrophilic actives were selected to demonstrate the efficacy of thermal sintering (60-65% w/w) using Kolliwax grades; and present processing parameters to enable customers to reproduce controlled drug release of hydrophilic drugs using thermal sintering.
Sponsored by BASF

Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience