BioPharm International October 2016

October 2016 | Volume 29, Issue 10
BioPharm International October 2016 Issue
Cover Story
Multiparticulates are increasingly used due to their flexibility in providing controlled-release, fixed-dose combinations, ease of taste-masking, and suitability for pediatric applications
Challenging molecules and markets are driving the development of new solutions for drug delivery.
Features
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.
A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.
Peer-Reviewed Research
An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.
Analytical Best Practices
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
Supply Chain
Ensuring that drugs retain their safety and efficacy requires careful selection of temperature-control technologies.
Regulatory Beat
Efforts to accelerate drug development will alter fee structure and require ready production sites.
Perspectives on Outsourcing
This key bioprocessing segment is expecting continued growth.
Ask the Expert
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
From the Editor
BioPharm International editors seek bioprocessing experts to contribute technical articles in 2017.
Product Spotlight
By BioPharm International Editors
The CELLdisc from Greiner Bio-One is a multilayer cell culture vessel that offers a growth area of up to one square meter for adherent mammalian cells.
By BioPharm International Editors
The Print & Check Flex Machine from Antares Vision is a flexible high-capacity serialization unit created for track and trace.
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