BioPharm International serves as the voice of an experienced mentor to the biopharmaceutical community.

BioPharm International provides a forum for its readers to exchange practical, hands-on information for developing and manufacturing pharmaceutical products through biotechnology; and serves as a supportive, authoritative voice in the evolving business, regulatory, scientific, and technical areas of the biopharmaceutical industry.

BioPharm International is the longest running peer-reviewed publication serving professionals involved in developing and manufacturing biotech therapeutics.

This global audience comprises of scientists, directors and executives in R&D, quality assurance/validation, process development, manufacturing, regulatory affairs and other professionals involved in critical functional units of biopharmaceutical organizations.

Free Subscription to BioPharm International

Geographic Eligibility: USA & Europe

Offered Free by: Advanstar Communications, Inc.

Read the Digital Issue: BioPharm International, August 2009

FEATURES
QUALITY
Analytical Tools for Process and Product Characterization
Brent S. Kendrick, Greg Chrimes, Steven L. Cockrill, John P. Gabrielson, Kelly K. Arthur, Brad D. Prater, Qiang Qin, Bing Zhang, Anurag S. Rathore
Disulfide linkage analysis, glycan analysis, analytical ultracentrifugation, and flow injection protein analysis can help achieve a product with consistent critical quality attributes. 32

PROCESS MONITORING
Use of Change-Point Analysis for Process Monitoring and Control
Patrick Gavit, Yaseer Baddour, Rebecca Tholmer
Two case studies demonstrate how change-point analysis offers several advantages over other methods of detecting data shifts. 46

CONTINUOUS IMPROVEMENT
Embedding a Culture of Continuous Improvement & Lean Manufacturing Across Pfizer Global Manufacturing
Gerry Migliaccio, John Scott
To implement Lean and Six Sigma at all facilities, leadership at each site was key. 56

MANUFACTURING ECONOMICS: PROCESS MODELING
Garbage In, Garbage Out: The Case for More Accurate Process Modeling in Manufacturing Economics
Rick Johnston, David Zhang
Good models are essential to establish accurate economic metrics for retrofitting scenarios.

Visit BioPharm International Website

BIOPHARM INTERNATIONAL serves the field of biopharmaceutical technology including biopharmaceutical manufacturing, biologics manufacturing, classical pharmaceutical manufacturing, biodiagnostic manufacturing, biopharmaceutical and biologics process development, biodiagnostic process development, biotherapeutic discovery and development, biopharmaceutical formulation and delivery, transgenic therapeutic productions, biotechnology research and biopharmaceutical research.

BIOPHARM INTERNATIONAL also serves specialty or bulk chemical manufacturing, architecture, engineering, construction, contract research and analytical services, government; universities, colleges, and research institutes; business, investment, and legal services; and others allied to the field.

FROM THE EDITOR
Laying the Foundation
Whenever a new FDA commissioner is named, the pharmaceutical industry wonders how drug regulation will change. The big question is, Will the pendulum swing toward increased scrutiny of safety concerns, or toward faster approvals? The current commissioner, however, is being asked to address a more prosaic issue first, relating to the everyday management of the agency’s work, particularly the people and resources involved.

In recent years, a few lawmakers have loudly criticized the agency for failing to meet all its responsibilities. Now, in a new report, the General Accountability Office (GAO) has made a calm and comprehensive analysis, rightly pointing out the gaps in the agency’s own knowledge of what it has, does, and needs. ...

Comments (0)

Name

Email

Comment

smaller | bigger

Add Comment