BioPharm International-08-01-2002

BioPharm International

Guest Editorial: Quality Agreements with Contract Laboratories

August 15, 2002

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by Roby Blasini, Pharmacia Corporation Creating Documents that Meet GMPs and Make Good Business Sense

Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question

August 15, 2002

GMP Excellence

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by Massoud Lavian and Paul W. Allen, Clarkston Consulting Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs your company money, time, and reputation. Proactive managers understand the logic behind FDA regulations and prepare accordingly. This three-part survival guide to inspections (whether from FDA, a client, an investor, or a European agency) will sharpen your vision of your company?s regulatory compliance picture.

Virus Inactivation in the 1990s ? and into the 21st Century: Part 2, Red Blood Cells and Platelets

August 15, 2002

GMP Excellence

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by Gail Sofer, BioReliance Smallest of the parasites, viruses depend completely on other cells (animal, bacterial, or vegetable) for reproduction ? several hundred viruses infect humans. Viruses can be inactivated by extremes of pH, heat, UV, desiccation, antiseptics, disinfectants, and organic solvents among others. The trick is in finding the right antiviral method for a particular virus ? without harming the biological product of interest. With Part 2 of this literature survey, we look at viral inactivation methods for RBCs and platelets.

Making Regulatory Compliance a Core Process: Director and Officer Liability Exposure

August 15, 2002

GMP Excellence

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by Joseph F. Noferi, Edward R. Arling, and Ralph H. Dillon, Pharmacia GS API Biopharma, global supply, and Daniel E. Worden, Worden Enterprises FDA is no longer complacent, punishing noncompliant companies with puny fines, those small slaps at the financial bottom line. FDA?s thunder now includes multimillion dollar fines, permanent injunctions, and prison sentences for senior executives. Companies that emerge as winners in today?s environment are those that treat compliance and risk management with the same flawless planning and execution that they use for their business plans and their financial investments.

Inside Washington: User Fee Program Seeks to Spur Biotech Development

August 15, 2002

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PDUFA III boost manufacturer fees to cover postapproval surveillance and streamline the FDA review process

Analytical Advances: Mapping Proteins – the 2-D Electrophoresis Issue

August 15, 2002

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by Kevin McAloon, Morgan Advanced Ceramics

Your Vested Interests: Gorillas In Our Midst

August 15, 2002

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by Benjamin H. Rudolph, Aptagen, Inc. Having a big name on your team isn't enough, but it sure helps!

Outsourcing Outlook: How to Engage in a Strategic Outsourcing Relationship

August 15, 2002

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by Les Blumberg, The Warren Company, and Jim MIller, Bio/Pharmaceutical Outsourcing Report Strategic Outsourcing requires discipline so companies can realize the competitive benefits in the marketplace

Throughput Analysis and Debottlenecking of Biomanufacturing Facilities ? A Job for Process Simulators

August 15, 2002

Save Time, Save Money

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by Demetri Petrides, Alexandros Koulouris, and Charles Siletti, Intelligen, Inc. Bottlenecks are everywhere, from the freeway overpass during the morning commute to the long lines at the supermarket. But bottlenecks in a manufacturing process are bad for business. Computer models can help you eliminate those conditions or situations that retard your progress. Whether the goal is strategic planning, evaluating alternatives, purchasing equipment, appraising a facility, or optimizing production processes, simulation tools can improve your analysis.