BioPharm International-10-01-2016

Ask the Expert

October 02, 2016

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.

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.

High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.

From the Editor

October 01, 2016

BioPharm International editors seek bioprocessing experts to contribute technical articles in 2017.

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.

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.

Regulatory Beat

October 01, 2016

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Perspectives on Outsourcing

October 01, 2016

This key bioprocessing segment is expecting continued growth.

A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.

Analytical Best Practices

October 01, 2016

Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.

Product Spotlight

October 01, 2016

The Print & Check Flex Machine from Antares Vision is a flexible high-capacity serialization unit created for track and trace.

Product Spotlight

October 01, 2016

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.

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