BioPharm International, January 2014 - BioPharm International

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BioPharm International, January 2014
Cover Story
2014 Manufacturing Trends and Outlook
By Rita Peters
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
Feature
Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody Fragments
By Claire Scanlan , Jeffrey Shumway , Mark Wagner , Ruta Waghmare , Juan Castano
Antibody fragments pose unique challenges in recovery, purification, and formulation.
Progress in the Prediction of Protein Aggregation
By Cynthia Challener, PhD
Techniques to enable the design and formulation of stable, protein-based therapeutics.
Peer-Reviewed Research
Determining Criticality—Process Parameters and Quality Attributes Part II; Design of Experiments and Data-Driven Criticality
By Mark Mitchell
Criticality is used as a risk-based tool to drive control strategies.
Regulatory Beat
Metrics Sought to Ensure Drug Quality
By Jill Wechsler
Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
European Beat
Early Communication with Regulators is Essential for SMEs
By Sean Milmo
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
Perspectives on Outsourcing
R&D in Transition
By Jim Miller
The R&D model is in transition and creating new demands on contract services providers.
Boot Camp Technical Guide
Best Practices in Adopting Single-Use Systems
By John Schmitz
Key considerations for implementing single-use components or platforms when moving from research to process development.
Burrill on Biotech
Life-Sciences IPOs Take a Breather
By G. Steven Burrill
Frenzy cools as investors seeking a quick return turn elsewhere.
Global News
Innovation and Market Growth in Brazil
By Hellen Berger
Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.
From the Editor
Drugs At What Cost?
By Rita Peters
Generics, market dynamics, and global demand are changing drug spending patterns.

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