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BioPharm International-10-01-2016
BioPharm International
Defining Risk Assessment of Aseptic Processes
October 02, 2016
Ask the Expert
29
10
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Real Time Continuous Microbiological Monitoring
October 01, 2016
Features
29
10
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
Optimizing Temperature Control for Biopharmaceuticals
October 01, 2016
Supply Chain
29
10
As the pressure to bring drugs to market more quickly increases, companies are faced with the challenge of selecting the most effective cold-chain storage solutions.
HPLE Sugars Improve Stability and Drug Product
October 01, 2016
Features
29
10
High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.
Calling All Authors
October 01, 2016
From the Editor
29
10
BioPharm International editors seek bioprocessing experts to contribute technical articles in 2017.
Multiparticulate technologies hot for controlled release
October 01, 2016
Cover Story
29
10
Multiparticulates are increasingly used due to their flexibility in providing controlled-release, fixed-dose combinations, ease of taste-masking, and suitability for pediatric applications
New Drug-Delivery Methods: From Concept to Patient
October 01, 2016
Cover Story
29
10
Challenging molecules and markets are driving the development of new solutions for drug delivery.
Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody Part III: Effect of Glass Transition Temperature
October 01, 2016
Peer-Reviewed Research
29
10
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.
Manufacturers Face Major Changes under PDUFA VI
October 01, 2016
Regulatory Beat
29
10
Efforts to accelerate drug development will alter fee structure and require ready production sites.
Fill/Finish Outsourcing
October 01, 2016
Perspectives on Outsourcing
29
10
This key bioprocessing segment is expecting continued growth.
Virus Risk Mitigation in Cell Culture Media
October 01, 2016
Features
29
10
A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.
Establishing Acceptance Criteria for Analytical Methods
October 01, 2016
Analytical Best Practices
29
10
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
Serialization Unit for Track and Trace
October 01, 2016
Product Spotlight
29
10
The Print & Check Flex Machine from Antares Vision is a flexible high-capacity serialization unit created for track and trace.
Cell Culture Vessel for Adherent Mammalian Cells
October 01, 2016
Product Spotlight
29
10
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.
BioPharm International, October 2016 Issue (PDF)
October 01, 2016
Issue PDF
29
10
Click the title above to open the BioPharm International October 2016 issue in an interactive PDF format.