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Current Issue

Developing a Best Practice Guide for Leachables Risk Assessment, Study Design, and Analytical Methods
Kathryn McGohan, Scientist I…
Single-use systems (SUS) offer biopharmaceutical manufacturers significant gains in process flexibility…

Continuous Bioprocessing:  PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release
Jeffrey Doyle, Manager…, Paul Jeffers, Manager…, Seamus O’Neill, Analytical Chemist…
Continuous bioprocessing offers potential to enhance productivity and product quality…

Analytical Strategies for Comparability in Bioprocess Development
Christine P. Chan, Ph.D., Principal Scientist…
Comparability exercises are commonly required at certain milestones during drug development as well as after product…

Technical Papers

Cleanability and Re-usability of Cadence™ Inline Concentrator Modules

Pall’s single-pass tangential flow filtration (SPTFF) is a new technology that utilizes a staged flow path design to achieve significantly higher concentration factors than a conventional tangential flow filtration (TFF) system in one pump pass.... Read More

Investigation into the Effect of Ageing of a Lipid Based Formulation on API Dissolution Release for Soft Gelatin Capsules

The goal was to investigate the effect of bulk storage time of a lipid based formulation on API dissolution release behavior for soft gelatin capsules.... Read More

Improvement of Physical Stability of Soft Gelatin Capsules by Film Coating

Physical stability of certain soft gelatin capsules stored at high humidity and elevated temperature can be a concern. The purpose of this study is to improve the physical stability of soft gelatin capsules by film coating.... Read More

Production of Nanoemulsion Adjuvants using High Shear Fluid Processing

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CHO Cell Cultivation in the Allegro™ XRS 20 Bioreactor System with Working Volumes from 2 to 25 L

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Process Development of a Drug Delivery Nanoemulsion and Post Process Sterile Filtration

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Understanding Single-Pass Tangential Flow Filtration and the New Era of Bioprocessing

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Pall SoloHill® Animal Protein-Free Microcarriers for Dengue Virus Production

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Feasibility of a Rapid Microbiological Method for Filterable Raw Materials

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Understanding Single-Pass Tangential Flow Filteration and the New Era of Bioprocessing

Single-pass tangential flow filtration (SPTFF) technology from Pall Corporation is revolutionising...... Read More

Managing Key Microbial Quality Control Tests within a Single Technology

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Shimadzu launch 7th Phase for Environmental Monitoring Project for UNU-IAS

Category: Regulatory

Shimadzu Corporation, Kyoto Japan, has been supporting the United Nations University's project of environmental monitoring and analysis of hazardous substances in Asia since 1996. In efforts to further advance this dynamic joint project to manage environmental pollutants in Asia, Shimadzu Corporation and the United Nations University Institute for the Advanced Study of Sustainability (UNU-IAS) have reached an agreement to enter into the 7th phase, featuring the global monitoring of perfluorinated compounds in sediment and biota samples.... Read More

TaiGen Biotech announce exclusive licensing agreement with Productos Científicos S.A. de C.V.

Category: Regulatory

TaiGen Biotechnology Company, Limited have announced that they have signed an exclusive licensing agreement with Productos Científicos S.A. de C.V.... Read More

Chugai make application to MHLW for approval of Actemra® Subcutaneous Injection additional dosage

Category: Regulatory

Chugai Pharmaceutical Co., Ltd. have announced that it has filed an application with the Ministry of Health, Labour and Welfare for the approval of an additional dosage of "Actemra® Subcutaneous Injection," the humanized antihuman IL-6 receptor monoclonal antibody, in patients with rheumatoid arthritis who inadequately respond to the currently approved every other week dosing regimen.... Read More

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