Newsletter | September 10, 2024

09.10.24 -- A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions

SPONSOR

Transforming the Biopharma Supply Chain, eData Solutions for Agility and Manufacturing Efficiency

Watch our engaging webinar to discover how eData empowers biopharma supply chains with process automation, critical analytics, and predictive logistics. Learn how manufacturers can proactively mitigate disruptions and adopt a standardized digital platform for resilient operations. Watch it here.

INDUSTRY INSIGHTS

Maximizing Automation ROI In Modular "Plug And Produce" Environments

To fully optimize their efficiency, modular facilities require integrated modular automation systems. Learn why modular automation is critical.

How The Cloud, Advanced Analytics, And Better Data Flow Are Transforming Pharma QC

Conventional QC workflows often involve manual data entry and transfer, which can result in errors. Discover how one partnership is seeking to streamline and unify data management in QC.

The Advantages Of Blow/Fill/Seal Processing For Vaccine Production

Multicomponent filling and sterilizing systems represent unique advantages for vaccine production. See how B/F/S systems can be adapted for vaccine production without incurring any product degradation.

How To Secure A Sustainable Supply Of Raw Materials

How can pharma companies secure the supply of vital APIs and intermediates and maintain consistent manufacturing costs? These steps minimize supply chain insecurity in a rapidly changing market.

Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation

In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

Aseptic Environmental Monitoring For Vaccine Manufacturing

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

How To Accelerate And Enhance ADC Therapies

Learn how payloads and advanced payload intermediates can expedite drug development and elevate ADC therapies, and explore ADC payloads, payload intermediates, and solubility-enhancing technology.

Application Of A Novel Temperature Shift Process For Particle Engineering

Spray drying of amorphous dispersions improves solubility and bioavailability that enables supersaturation in the intestine, driving higher absorption rates when compared to crystalline drug forms.

How To Adapt Efficiently To A New Era Of Supply Chain Manufacturing

It’s no secret – COVID-19 changed things. Now, as the pharma supply chain settles into a new normal, executives are shifting focus to better identify reliable, resilient, and forward-thinking partners.

A Checklist For Efficient And Reliable Gene Therapy Manufacturing

Gain insight into how to design and execute an efficient upstream AAV production process, and follow the checklist within to ensure all appropriate factors are considered at each phase of drug development.

Nasal Vaccine Development, Manufacturing, And Device Selection

When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

Risk Management Processes For Cell And Gene Therapies

Delve into several considerations of risk and knowledge management in the cell and gene therapy environment, providing essential insights for effective product development.

Formulation Development For Injectables

A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.

Broader, Faster, And Greener ASD Technology

Explore 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.

FEATURED EDITORIAL

A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions

Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

SPONSOR

Webinar: Regulatory Confidence - Getting the Rheology Right for Generic Topical Pharma Submissions

The process of demonstrating the equivalence of a topical pharmaceutical to a reference listed drug when submitting a new drug application is challenging. This includes facing regulatory affairs personnel when navigating the often-daunting landscape of rheological measurements. In this webinar we explain rheology terminology, core concepts, and show examples of how the required rheology profiles can be generated on high performance rheometers.

SOLUTIONS

How Airflow Visualization Characterizes Pharmaceutical Sterility

Cleanroom Technology For Unparalleled Cleanliness And Speed

High Speed In-Line HVLD For Pre-Filled Syringes

Adare Pharma Solutions Capacity Update May 2024: Small Molecule APl And HPAPI Development

Contract Pharmaceutical Blister Packaging Services

Sustained Release Drug Delivery Platform

Mechanistic Chromatography Modeling To Accelerate Process Development

Highly Flexible And Customizable On-Body Delivery System Platform

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