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Feature Articles

Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations

April 1, 2014

USP evaluates raw materials used in the chemical synthesis of peptides.

Raw Material Variability

April 1, 2014

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

Predicting Lyophilization Performance

March 1, 2014

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

Achieving Supply Chain Excellence in Single-Use Systems

March 1, 2014

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

Control Strategies for Synthetic Therapeutic Peptide APIs— Part I: Analytical Consideration

March 1, 2014

USP evaluates quality attributes for synthetic peptides.

Advances in Linker Technology

March 1, 2014

The targeted delivery of cytotoxic drugs using antibody drug conjugates would not be possible without effective linkers to connect and then release the key chemical and biological materials.

An Environmental Lifecycle Assessment of Single-Use and Conventional Process Technology: Comprehensive Environmental Impacts

March 1, 2014

An environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.

Innovation in Pre-packed Disposable Chromatography Columns

March 1, 2014

Research uncovers trends and factors affecting the pre-packed disposable chromatography columns market for downstream bioprocessing.

Single-Use Technology for Syringe Filling

March 1, 2014

A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.

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