Newsletter | June 27, 2024

06.27.24 -- Design And Function Of GMP Transition Spaces

INDUSTRY INSIGHTS

Supply Chain Resilience

Ensure a stable and reliable supply of essential medications for patients by proactively addressing pharmaceutical supply chain challenges and embracing innovative risk management strategies.

Four Trends Redefining The Life Sciences Industry

The COVID-19 crisis acted as a catalyst for digital transformation in the industry. Learn how this transformation has impacted trends and new possibilities in the life sciences sector.

The Challenges Batch And Continuous Manufacturing Bring To Containment

There are two basic models of pharma manufacturing: batch and continuous. Here, we compare the two and examine the challenges they bring to containment product design.

Taking The First Step In Creating An Intelligent Laboratory

Learn how the implementation of a lab management system has enabled one company to accelerate its operations and initiate its journey toward establishing a truly intelligent laboratory.

Demystifying Lyophilization: Understanding The Freeze-Drying Process

Advancements in lyophilization technology and research have helped overcome inherent challenges and ensure the safety and efficacy of lyophilized pharmaceuticals.

Closing The ‘Knowing-Doing’ Gap In R&D Using USP <1062> Data

Data acquisition system tools have come a long way, and now you can learn which trial runs will help you generate the most valuable data.

Embrace A Contract Manufacturer Partnership That Drives Sustainability

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

Why “Off-The-Shelf” Devices Do Not Circumvent Design Controls

Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs. Understand the design control responsibilities of a sponsor when using OTS devices.

Implement A Risk-Based Approach To Safely Manufacture HPAPIs

As interest in HPAPIs as powerful therapeutic mechanisms continues to grow, drug manufacturers must design thoughtful risk-based containment strategies to protect employees and ensure safety.

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.

Process Re-Design For Sustainability In Small Molecule Manufacturing

Review the optimization of the manufacturing process of a pharmaceutical intermediate, and discover how yield can be improved substantially via suitable reaction engineering.

Embedded CMO: From Development Through Commercialization

The right CMO can expedite market launch, and an embedded CMO offers many advantages over other CMO models, including access to the extensive capabilities and knowhow of the parent organization.

Selecting Drug Delivery Systems For Higher Viscosities And Lower Risk

Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

Transitioning From Research To Drug Formulation And Development

The transition from academic research and studies to industry research demands that individuals master additional skills, set different objectives, and define “success” differently.

Automating Cell Based Assays, Reducing Variability And Time To Results

Cell-based assays present a unique challenge due to inherent starting material biological variations. Explore the development of a cell-based potency assay implemented on an automated platform.

Structural And Chemical Analysis Of IC-Chip Cross Sections

How can you optimize your workflow for advanced materials analysis concerning applications in the electronics industry? Discover a step-by-step guide.

A Processing Technology For Meeting The Challenge Of Poor Solubility

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

Design And Function Of GMP Transition Spaces

In pharma/biotech GMP, there are several spaces that function as transition spaces, such as airlocks. This deep dive discusses how procedure and arrangement can influence their effectiveness.

SOLUTIONS

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