Newsletter | April 18, 2024

04.18.24 -- Designing Highly Agile Bio/Pharma Manufacturing Facilities

FEATURED EDITORIAL

Designing Highly Agile Bio/Pharma Manufacturing Facilities

In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.

INDUSTRY INSIGHTS

Strategies To Address The Viral Vector Manufacturing Shortage

Accelerating the production of your viral vector-based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

Developing Drug Placebo Formulations For Pharmaceutical Clinical Trials

Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

The Aqueous Cleaning Handbook

This handbook is intended to assist laboratory and manufacturing plant scientists and engineers in accurately selecting and maximizing the performance of aqueous cleaners and systems.

Protecting Human Health With Organ-On-A-Chip Technology

Explore compelling evidence that suggests Organ-on-a-Chip technology offers a far more reliable means of predicting drug toxicity than conventional animal models.

Why And How To Replace Dye Ingress Test By Deterministic CCIT Methods?

Understand the challenges and limitations of the blue dye test and see how the sensitivity of the blue dye test compares to other methods based on a comprehensive study.

Streamline Early-Stage Development To Reach The Clinic Faster

Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.

Formulation Technologies For Developing Dry Powders For Inhalation

Examine challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches.

The Value Of Closing Your Process

For R&D and PD applications, closed, single-use systems can protect against both biological and cross-contamination, saving valuable research time and money.

A New Mindset For Combination Product Development

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

How Digital Transformation In Sample Management Increases Efficiency

Explore a real-world example of how a dynamic and growing CDMO implemented a lab management system to improve efficiency and data integrity for their quality control sample management workflows.

Multi-Agitator High-Shear Mixing System Assists In CMC Dispersions

Conventional agitators are unable to create the fluid circulation necessary to disperse 4%+ powdered CMC dispersions. The consequence of insufficient agitation is the formation of non-dispersed lumps.

Streamlined Selection Of In Vivo Predictive Dissolution Media

Explore the design of dissolution media to support biopredictive dissolution testing and a method for selecting practical, physiologically relevant media based on drug, formulation, and GI fluid properties.

Optimizing Process Loads For VHP Decontamination

Learn how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

Kinetisol Technology: Broader. Faster. Greener.

Discover how a solvent-free alternative for the production of amorphous solid dispersions (ASDs) not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

Novel Engineered Plasmids, Optimized HEK293 Cell Line For AAV Productivity

Lonza has further improved its platform process with the creation of engineered plasmids that afford significantly higher titers and productivity levels compared to standard systems.

SOLUTIONS

A HPLC System For Easy Method Migration

Modeling Platform To De-Risk Container-Closure Selection

Small Molecule APIs: From Pre-RSM To Final API

The Industrial DataOps Solution For Industry 4.0

Aseptic Fill/Finish Service

Making The Complex, Simple.

Contrast In Oligonucleotides

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