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Pharma 2010: The Threshold of Innovation

(Whitepaper)

The pharmaceutical future belongs to companies able to deliver "targeted treatment solutions," claims this visionary report, part of IBM Business Consulting Services Pharma 2010 series. This brief but sweeping report focuses on how firms can get ahead and stay ahead in the targeted treatment game.

Using PAT in Risk-Based Development and CMC

(Whitepaper)

This July presentation by Professor Kenneth R. Morris, Purdue University's Department of Industrial and Physical Pharmacy, discusses the use of PAT in a risk-based approach to drug development and CMC.

Assessing Magnesium Stearate's Effect on Blends

(Whitepaper)

Crystallization Made Crystal Clear, Part 1

(Whitepaper)

Pharmaceutical Security through Stable Isotopes

(Whitepaper)

RFID's Frequency Controversy

(Whitepaper)

Selecting the Right Biotech Partner

(Whitepaper)

Biotech firms have to aggressively manage interaction with potential partners, says this informative white paper by Vantage Partners, relationship and negotiation consultants.

Crystallization Made Crystal Clear, Part 2

(Whitepaper)

A Closer Look at Low-Frequency RFID

(Whitepaper)

Continuous Processing in Pharmaceutical Manufacturing

(Whitepaper)

This paper provides an overview of the continuous processing landscape — from dealing with FDA to the intricacies of continuous chemical reactions. The authors, from Pfizer Inc.’s Pharmaceutical Sciences division, say the industry will change dramatically in the next decade.

Combination Products: FDA Issues Draft of cGMPs

(Whitepaper)

In its recently released “Pharmaceutical cGMPs for the 21st Century—a Risk-Based Approach,” FDA provided some initial guidance on good manufacturing practice for combination products (such as drug and device pairings). This is a draft document, meant to elicit comments and concerns

Online Education on RFID Package Tagging Basics

(Whitepaper)

Standards for Pharmaceutical Applications of PAT

(Whitepaper)

This presentation by Don Marlowe, FDA Standards Coordinator in the Office of the Commissioner, outlines the ASTM E-55 Committee's efforts in developing PAT standards for pharmaceutical applications.

Factors Affecting the Accuracy and Reproducibility of Gradient Formation for ...

(Whitepaper)

This Amersham Biosciences/GE Healthcare paper examines the impact of various factors — temperature, composition and delivery method of stock buffers and solvents — on gradient performance in preparative liquid chromatography.

Aseptic Processing Final Guidance

(Whitepaper)

As part of its 21st Century cGMPs, FDA (jointly with HHS, CDER, and other agencies) offers guidance on aseptic processing used in the manufacturing of sterile drugs.

Productivity and the Economics of Regulatory Compliance

(Whitepaper)

This presentation developed by PriceWaterhouseCoopers Consulting examines the connection between compliance and cost savings.

Don't Neglect Compressed Air Costs

(Whitepaper)

Many companies today are focusing on reducing energy costs to lower overall manufacturing costs. However, they often overlook compressed air, which can have a significant impact on electricity costs. This paper quantifies the cost of compressed air leaks and illustrates how the efector Metris ...

New Opportunities in Pharmaceutical Manufacturing

(Whitepaper)

This 2001 presentation to FDA's Science Board, helped spark the pharmaceutical manufacturing quality revolution and use of PAT in drug manufacturing. Dr. Raju is head of CAMP, MIT's program on the pharmaceutical industry, and CEO of the consulting firm, Light Pharma.

Use Electronic Data Capture to Optimize Weighing and Dispensing Operations

(Whitepaper)

Traceability weighing and dispensing optimization systems represent a comprehensive solution to reduce drug manufacturing costs, increase productivity and efficiency, improve time-to-market and drive regulatory compliance.

The Coming Wireless Market

(Whitepaper)

The North American market for wireless monitoring and control products is taking off. This paper by Venture Development Corp. tells which direction it’s headed.

Best Practices for Developing a Process Control Network

(Whitepaper)

This Invensys White Paper describes best practices for setting up a Foxboro I/A Series A process control system network and its interfaces to a corporate network.

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