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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

... Read More


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

... Read More


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

... Read More


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

... Read More


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

... Read More


Feasibility of a Rapid Microbiological Method for Filterable Raw Materials

... Read More


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

... Read More


Headlines

SP Scientific acquire ControLyo™ Nucleation Technology

Category: Mergers & Acquisitions

SP Scientific has purchased ControLyo™ Nucleation Technology and all related patents from Praxair Inc. ... Read More


Merck launch Viresolve® Pro Shield H

Category: Manufacturing

Merck is launching the Viresolve® Pro Shield H for removal of parvoviruses from therapeutic protein feed streams.
... Read More


Colorcon & Dow broaden their Controlled Release Alliance

Category: Regulatory

Colorcon Inc. and The Dow Chemical Company have announced an agreement to broaden the existing Controlled Release Alliance between the two companies.... Read More


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