Drug Delivery Resource Center

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Biomanufacturing Morphs
In biopharma, budgets are returning and manufacturers are emphasizing innovation, productivity, and cost control.

Looking for Supply Chain Answers in 2011
Interest in protecting the drug supply chain is becoming top of mind for drug manufacturers, technology providers, and governments as they begin to understand the current and elevated risks to patient safety.

A New Entry in Pharma Materials Inspection Market
PharmaManufacturing.com
At AAPS 2010 in New Orleans, Travis Thompson of Delta Nu talks about his company's new Raman-based handheld materials ID solution.

Biotech Production: Planning, Scheduling and Throughput Analysis with a Combined Theory of Constraints, Lean and Simulation Approach
A major biotech company's only final stage bio-manufacturing facility in the world was struggling to meet rapidly increasing customer demand. Unanticipated production delays and frequent starvations at critical parts of the operation were causing not only late and missed deliveries, but also the expiration of product batches at a cost of approximately $1 million per batch.

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White Papers: In Depth Research

Avoiding No Man's Land: Potential Unintended Consequences of Follow-On Biologics
Author: Deloitte
Posted: 01/05/2010
Still, the essential debate encompasses two broad issues: patient safety and industry economics. This paper from Deloitte explores what will constitute threshold biosimilarity? The definition of biosimilarity is likely to involve standards regarding the degree to which a follow-on biologic has the same mechanism of action (i.e., if it targets the same molecular disease regulator) as the original drug, and if it passes efficacy and safety screens.

Best Practices in Demand and Inventory Planning
Author: CDC Software
Posted: 02/09/2009
It's a classic scenario in pharmaceutical manufacturing, struggling to coordinate the opinions of sales and marketing with clinical opportunities and manufacturing/supply chain initiatives on what, when, and where a product should be produced. This white paper provides details on best practices that can help you organization overcome these challenges.

SAP Support of the Healthcare Supply Chain’s Ongoing Effort to Ensure Patient Safety and Drive Business Value
Author: SAP
Posted: 12/05/2008
This white paper provides a detailed look at SAP’s support for the Center for Healthcare Supply Chain Research Blueprint for Data Management & Data Sharing. It also offers a summary of the Blueprint concepts and a review short- and long-term business improvement opportunities that can be gained by leveraging EPCIS.

Residual Solvents by HT3 Headspace in Reference to USP 467 with a Comparison of Static Versus Dynamic Headspace Analysis
Author: Teledyne Tekmar
Posted: 09/22/2008
Residual solvents in pharmaceuticals are defined as volatile organic chemicals that are used or produced in the manufacture of drug substances, excipients or in the preparation of drug products. Because residual solvents do not provide therapeutic benefits, they should be removed, to the extent possible. Drug products should contain no higher levels of residual solvents than can be supported by safety data. Looking forward to the implementation of a revised USP 467 method, Teledyne Tekmar evaluated the new protocol, therefore this application will comply with the procedure and criteria changes set forth in the USP30 NF25, Second Supplement (effective December 1, 2007) and the interim revision announcement.

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