A number of deals and partnering agreements, increasing focus and segmentation, greater regulatory scrutiny and the emergence of biogenerics are key biopharma trend.
By Sangita Viswanathan

Injectable Drug Delivery for Protein Life Cycle Management It is important to revisit basic concepts of parenteral science to avoid adverse interactions between proteins or formulation excipients and container closure systems.
By Dr. Mahesh Chaubal

High Resolution Ultrasonic Spectroscopy:A High-Potential Tool
HRUS can be used for analyzing a broad range of important properties of different raw materials, excipients and final formulations.
By Evgeny Kudryashov, Dr. Cormac Smyth, Breda O'Driscoll and Dr. Vitaly Buckin

On The Docket
- Access to Information for QA/RA Professionals: Services used by attorneys may also be useful to pharmaceutical quality and regulatory professionals.
By Alan G. Minsk

Excipient Focus: Gums & Binders
- Hydrocolloids as Tablet Binders: Parameters required for gum functionality and properties should be considered when selecting specific gums as tablet binders.
By Dr. florian m. Ward

QA/QC
- Screening Raw Materials for Microbial Contamination:Rapid microbial screening of raw materials benefits from the specificity and acceleration of adenylate kinase. technology
By Judy Madden

GMP Notebook
- Quality Risk-Management: The application, principles and power of quality risk-management must be embraced.
By Dr. Efrem H. Zaret

NIR Spectroscopy
- The PAT Front End Using FT-NIR: Move beyond raw material ID and into manufacturability and control.
By Scot Ellis and Brian Davies

International Regulations
- Clinical Trials in the EU-Directive 2001/20/EC: Directive 2001/20/EC has brought some consistency to the process of filing EU clinical trial applications but is yet to achieve its full potential.
By Sharon Safranyos

Lab Analysis: Microbiology
- Proactive Response to Airborne Contamination:Monitor microbiological air within three hours using a solid-phase cytometer and a polymer collection tool.
By Pascal Yvon

Part 11
- Another Chapter in Part 11:The time is now to take a hard, careful look at your record retention policy.
By Jason Clegg

Security
- Debunking Top Myths of Plant Security:As awareness of plant floor security issues continues to grow, one frequent question is "what are the real risks to a manufacturing environment?"
By Bryan Singer