Newsletter | April 11, 2024

04.11.24 -- Quick Takes From Takeda Austria's Annex 1 Rollout

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FEATURED EDITORIAL

Quick Takes From Takeda Austria’s Annex 1 Rollout

At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

INDUSTRY INSIGHTS

ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments

Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.

Standardizing Content Management Across The Life Sciences Industry

Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

3 Steps To Digital-First Quality

Learn about a proven three-step process designed to help companies quickly transition to a modern quality control system and accelerate their all-digital quality management initiatives.

A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and container and delivery device selection.

Giving Production A Powerful Boost Through Digital Inline Printing

Gain insight into how technology is helping Recipharm in Pianezza reduce aluminum foil consumption in blister production by 30 percent while maximizing efficiency.

Considerations For Purchasing Low-Cost Manufacturing Equipment

No one can deny the cannabis industry is one to watch. Learn how used process and packaging equipment for the marijuana and CBD industry can fill a growing need for manufacturing equipment.

Microbial Air Sampling: Physical And Biological Collection Efficiencies

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.

Zero-Stress Low Volume Aseptic Filling For Solids And Liquids

Aseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.

Developing A HIC Polishing Step For The Removal Of mAb Aggregates

Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

Optimize Your Chromatography Process With Purpose-Built Connections

Downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. CPC designers identified a polymer to handle rough downstream chemicals.

SOLUTIONS

A Study Management And Method Execution Platform For Biopharma

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Pharmaceutical Manufacturing Cleaning And Disinfectant Bucket System

European Center Of Excellence For Clinical Biologics

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