Newsletter | June 30, 2022

06.30.22 -- De-Risking Your Pharma Supply Chain

 
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Industry Insights
Painless Precision For Process Automation

OCELOT System Control, a new automation software platform, offers all the capabilities of its competitors but with a user-friendly platform that simplifies implementation and operation.

What Can You Do To Improve Your ADC’s Chance Of Clinical Success?

Improving your ADC’s chance of clinical success requires an understanding of what potential obstacles lie ahead and what capabilities and expertise are necessary to overcome them.

7 Key Concepts In The FDA’s Quality System Guidance For Pharma

Here are some key concepts that the FDA deems critical for a discussion on modern quality systems and defines them within the scope of pharma manufacturing.

Evolutions In Pharmaceutical Validation

In this article we will discuss how the industry changed and how we can help you adapt to the new business environment.

Setting A Strong Foundation For Late-Stage Development

After Phase 1 and into Phase 2 trials, it's time to identify the quickest scale-up path for supplying efficacy trials and commercial demands while keeping the formulation as simple as possible.

Technology Transfers: A Beginner's Guide

You may have questions or knowledge gaps regarding technology transfers. To help your understanding, we’ve compiled a beginner’s guide to technology transfer fundamentals.

Improving Sterility Assurance Within Lower-Grade Cleanrooms

Better aseptic powder handling through the use of high-tech split butterfly valves can improve patient protection, improve working conditions for staffs, and cut costs through the use of lower-grade cleanrooms.

Managing Frozen Transport Logistics In The Biopharma Cold Chain

A framework for making decisions linked to cold chain management and potential solutions to the issues surrounding the frozen transfer of biopharmaceuticals.

Developing A Robust In Vitro Intestinal Model For Preclinical Candidate Screening Of GI Toxicity

This article reviews an in vitro human intestinal model that is helping to develop a system that could help pharma companies identify GI toxicity issues early in the drug development process.

Forecasting The Integrity Of The Biopharma Supply Chain

Receiving customer forecasts as early and completely as possible is critical to the success of the supply chain continuum.

Using Advanced Technologies To Formulate Complex Molecules

In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

Specialty Medicines: Keys To The Packaging Process

A panel of experts from the biopharmaceutical industry discussed key aspects of the clinical to commercial paradigm and best practices when managing the end-to-end packaging process.

Ensuring Resilience: Reshaping Supply Chains In Response To COVID-19

Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.

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.

Bombing: Leak Test Of Hermetically Sealed Objects

Learn more about the best practice of leak testing of hermetically sealed devices in microelectronics, sensor technology, and other industries.

Validation Of Four-Hour Active Sampling Using BioCapt Single Use

Learn how the BioCapt Single Use microbial impactor for cleanroom monitoring satisfies the requirements of new EU GMP Annex 1 and is an efficient device under stress conditions.

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