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June 2012 Editorial Line-up
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SPECIAL OUTSOURCING FEATURE
Determining Process Quality Metrics for CMOs – in Search of a Magic Formula
Kate DeRoche Lusczakoski, PhD, Aegis Analytical Corp
The life-sciences industry is witnessing two important manufacturing trends including adoption of Quality by Design (QbD) to enhance process understanding, which comes with its long list of consumer, regulatory and business benefits. The second trend is an increased use of contract manufacturing organizations (CMOs) to better manage plant capacity and control production volumes. As CMO relationships expand and QbD becomes more essential to business strategy, it is important to examine best practices for determining quality metrics across CMO and sponsor networks. |
Knowledge Management Implementation in a Biopharmaceutical Company
Tarun Jain and Bipul Pandey , Tata Consultancy Services Limited
Parliament Street, New Delhi
Knowledge management is one of the most important systems for any biopharmaceutical company. Knowledge management is considered a vital connection to other management subsystems in an organization. This paper focuses on the steps needed for successful implementation of knowledge management in a biopharmaceutical company. The approach to implementation discussed in the paper enables new possibilities for usage and exploration of valuable information existing in the company. Electronic Document Management System are discussed as well. |
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Editorial Theme: Outsourcing
Product & Services Spotlight: Outsourced Services |
SPECIAL ANNIVERSARY CONTENT
25 Years of Biopharmaceutical Manufacturing
A roundtable featuring BioPharm International editorial advisory board members and industry experts, looking back at the industry’s key achievements in analytics, manufacturing, quality, and more. Plus, where the industry is headed.
Featuring a 25-year timeline of industry milestones.
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Technical Retrospectives
Amy Ritter
An in-depth look at how key technical applications in nanotechnology and expression systems have shaped the biopharmaceutical manufacturing industry.
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Regulatory Challenges in the QbD Paradigm: The Evolution of Review and Inspection Practices
Anastasia Lolas and Anurag S. Rathore, Visionary Pharma Consulting, and Department of Chemical Engineering, Indian Institute of Technology, New Delhi, India
The dawn of the 21st century signaled that changes must be made by both the pharmaceutical industry and regulatory authorities across the globe. These changes are necessitated by a plethora of issues that are faced by the companies and the regulatory agencies alike. The number of blockbuster drugs launched each year had remained relatively constant at 6.5 per annum. The nearly threefold increase in R&D spending over the past decade has resulted in an increase in the number of drug candidates entering Phase I trials. This, along with the increasing scrutiny of healthcare costs in developed economies, has resulted in an unrelenting pressure on the pharmaceutical companies to control the drug development costs. Herein the authors provide a review of how this paradigm is faring from a regulatory perspective. |
Biologic FDA Approvals
Gary Walsh, EAB, University of Limerick
A look at FDA approvals of new biologic drug products over the years. |
A Retrospective and Forward Look at Biopharma Outsourcing
Eric Langer, BioPlan Associates
An overview of how outsourcing and contract services have changed in the biopharmaceutical sector. Plus: what’s expected in the years to come. |
Trends in Outsourcing Spend and Related Regulatory Approvals
Susan Scutti, That’s Nice, Nice Insights
A summary of industry spending trends based on Nice Insight’s research, with a brief look at FDA approvals as the outcome. |
The Most Influential Leaders in the BioPharma Industry
A roundup of leading players and their achievements. |
Snapshots from BioPharm’s First Volume
A look back at unique articles and quotes from BioPharm International. |
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From the Editor |
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Global News |
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Regulatory Beat: This month may include a special anniversary interview with FDA. To be confirmed. |
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Disposables Advisor by Jerry Martin |
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Compliance Notes |
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Bioanalytics: Introducing a new bimonthly column from MPI Research |
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Best Manufacturing Practice by Simon Chalk |
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Bootcamp Guide: Featuring Flexion Therapeutics |
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Final Word |
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Spotlight |
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New Tech Showcase |
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