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In this issue: News, interviews, and articles on drug safety, API synthesis, excipients for oral solid dosage drugs, fill/finish, and packaging, as well as global activity in drug development and contract outsourcing providers.

Outsourcing
Technology Improvements Drive Capacity Gains for Biologics Fill/Finish
In-house biologics fill/finish operations have invested in new technologies and have available capacity while small-molecule fill-finish facilities work at near capacity on legacy equipment.
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Baxter BioPharma Solutions Joins PBOA
Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.
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Regulatory Developments
EMA Launches Drug Safety Assessment Platform
The agency creates an electronic central repository to facilitate drug safety assessment reports.
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The Quest Continues for Quality Metrics
FDA aims to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.
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API Synthesis & Manufacturing
More Growth Expected for API Custom Manufacturing in 2015
Custom API manufacturers that offer specialized capabilities will benefit from the continuing trend toward pharmaceutical outsourcing.
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Manufacturing Developments
Extending Shelf Life through Better Blister Package Designs
Better barrier materials and software modeling streamline the blister-package design process.
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New Excipient Options for Oral Solid Dosage Drugs
Experts review considerations for selecting excipients for solid-dosage drug performance and manufacturability.
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Contract Services Roundup
PPD Announces Completion of Clinical Studies Facility in Ireland
PPD announced that it completed an expansion to its Athlone, Ireland facility, resulting in 20,000-square-feet of dedicated space for warehousing and distribution purposes.
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Catalent Expands High-Potency Handling Capability
Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.
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FUJIFILM Diosynth Begins Work on Bioprocess Innovation Center
The new facility will feature new research and development capabilities.
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SAFC Expands Irvine Facility
The new facility will feature dry powder cell-culture media capabilities.
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AMRI Acquires Two Aptuit FacilitiesK
The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.
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Ash Stevens to Manufacture Amotosalen API
FDA has approved the Ash Steven’s manufacturing facility in Riverview, MI for the manufacture of Amotosalen.
>> Read More

Supplier News
Hovione Names Vice-President of R&D

BASF Announces Plans to Expand PVP Facilities

Argos and Saint-Gobain Partner on Single-Use Components for Immunotherapy Manufacturing

Webcasts
Pharma Supply Chain Security: Are You in Control?
Live broadcast on: February 25, 2015 at 11AM ET
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by Spectrum Chemical Mfg. Corp.