| SPECIAL SUPPLEMENT |

PharmTech's 2017 Outsourcing Resources PharmTech's annual Outsourcing Resources features insight on CMOs and flexible manufacturing, on-site supplier audits, clinical trials manufacturing, continuous processing culture, inhalation therapy development, blockchain and pharmaceutical supply chain security, and pharmaceutical project management. The issue also features a contract services company directory and Fast Locator for contract services. read more

| MANUFACTURING |

Using QbD in Topical Drug Manufacturing

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
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| FORMULATION |

Targeting Drug Delivery with ADCs

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
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| SUPPLY CHAIN |

The Role of Quality Standards for Biomanufacturing Raw Materials

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
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| ANALYTICS/QUALITY |

A Continuous Improvement Metric for Pharmaceutical Manufacturing

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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| PEER-REVIEWED RESEARCH |

Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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| APIs and EXCIPIENTS |

Optimizing Cell-Culture Media

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
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| REGULATORY WATCH |

Gottlieb Tackles Opioids, Drug Costs, and Innovation

FDA urges manufacturers to seek fast approval of "high-need" generics and targeted therapies.
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| OUTSOURCING OUTLOOK |

CDMOs: New Administration, New Frontier

Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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| ASK THE EXPERT |

A Look at Batch Record Review

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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| PRODUCT SPOTLIGHT |

Larger Peristaltic Pumps Allow Scale-Up

Watson-Marlow Fluid Technology Group (WMFTG) has expanded its range of peristaltic cased pumps for upstream and downstream bioprocessing tasks.
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Drying, Granulating, and Coating System Offers Modularity

The VENTILUS LE series for production-scale applications from Romaco offers three versions: LE-D for drying processes; LE-G for granulating fine solid particles; and the LE-C for coating them.
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Heavy-Duty Multi-Agitator Mixer

The VersaMix Multi-Shaft Mixer from Ross, Charles & Son is designed for large-scale production and enables repeatable batch processing of high-volume viscous applications.
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Single-Use Systems Expand Scale of Chromatography

Sartorius Stedim Biotech has expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes, a pod-like modular system for commercial applications in both capture and polishing.
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