Newsletter | January 28, 2025

01.28.25 -- 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025

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Webinar: The Future of Contract Manufacturing: Must-Know Trends and Strategies for 2025

Regulated industries are evolving due to consumer demand, technological breakthroughs, and global regulatory harmonization. Contract manufacturers must adopt AI and cloud solutions for agility, compliance, and operational excellence. This webinar explores trends in contract manufacturing, focusing on technology's role, economic pressures, and regulatory changes, with strategies for adapting to the changing landscape. Click here to learn more.

INDUSTRY INSIGHTS

Managing Supply For Complex Biotherapeutics

The antibody-drug conjugate manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill and finish.

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.

Select Drug Delivery Systems For Higher Doses, 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.

A Blueprint For Avoiding FDA Recalls

Avoid FDA recalls and safeguard your life sciences business. Learn how QMS and EBR/eDHR solutions can prevent costly product recalls and ensure compliance with FDA regulations.

Standardization And Flexibility In Aseptic Filling

Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?

Nanoparticle Enabled Formulation And Drug Delivery Solutions

Examine how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.

The Challenges And Opportunities Of Real-World Evidence: Part I

Explore how the FDA's Real-World Evidence framework helps integrate real-world data into drug approval, improving efficiency, while ensuring data reliability and regulatory compliance.

Form Fill And Seal Label Applicator For Drug Packaging

Discover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.

Robust Process Solutions To Purify GLP-1 Receptor Agonists

Watch to learn how to optimize GLP-1 production, how throughput and performance affect downstream processes in protein therapies, and how to enhance yield and purity for optimal process outcomes.

Modern Industrial Data Architecture Strategies And Best Practices

Explore the processes and technologies being utilized by life sciences manufacturers to achieve success on their Industrial DataOps maturity journey as well as real-world best practices from the field.

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.

Organ-Chips Outperform Animal Models And Spheroids

Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.

From Bench To Batch: Strategies For Scaling HPAPI Production

Highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed.

FEATURED EDITORIAL

5 Characteristics Of Forward-Thinking Microbiology Labs In 2025

Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

SOLUTIONS

Leave Paperwork Behind In Your CQV Process

Compliance Program For EU Annex 1 Container Closure Requirements

Solid Form Services

Biological Indicator Testing: Meeting Regulatory Demands With Confidence

Real World Dosing Solutions For Patients

Capacity Update October 2024: Fill/Finish

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