| API SYNTHESIS AND MANUFACTURING |

Faster, Cheaper, and Greener

Hazardous reagents can simplify processes and provide higher yields and purities.
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| TROUBLESHOOTING |

Preventing Film Coating Problems by Design

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.
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| STATISTICAL SOLUTIONS |

Measurement Uncertainty without the Math

Performing a measurement uncertainty calculation is often seen as problematic.
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| OUTSOURCING OUTLOOK |

Macro Matters

Heightened global uncertainty could slow bio/pharma development activity.
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| REGULATORY WATCH |

Innovative Therapies Require Modern Manufacturing Systems

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
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| ASK THE EXPERT |

Creating Robust CAPA Systems

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.
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| VIEWPOINT |

Innovating for Innovation

Suppliers must develop new technologies to drive the bio/pharma innovation engine.
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| FEATURES |

Going Small to Achieve Commercial-Scale Success

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
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Cold Chain: Going the Extra Mile

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.
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| PARTNERSHIPS IN OUTSOURCING |

The Impact of SEND on the Pharmaceutical Industry

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.
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Under New Ownership: Consolidation Reshapes Contract Services Market

Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.
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Quality Metrics and Best Practices for Working with Contract Labs

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.
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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