Newsletter | August 15, 2025

08.15.25 -- Audit Trail Compliance And What To Look For In Mitigation Software

SPONSOR

Delve into trending topics and pressing challenges facing the pharmaceutical industry at the 2025 ISPE Annual Meeting & Expo with experts from around the world. Explore a wide range of topics, including emerging trends in advanced therapies, practical risk-management approaches to enable innovation, strategies to help streamline validation, support for sustainability efforts, and opportunities to drive digital transformation. Learn more and register here

INDUSTRY INSIGHTS

Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

Viral Disinfectant Efficacy Studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting safe, effective disinfection.

Continuous Flow Chemistry (Processing) For Intermediates And APIs

Developing flow-based manufacturing processes requires expertise in several disciplines, the ability to design and build custom reactors, and the scientific infrastructure to support production.

Fast Track Your Path To Commercialization

Discover key strategies for scaling biologics from bench to pilot scale and watch how to overcome challenges in process development, including control of agitation, oxygen, and CO₂.

ITC: Unveiling Its Role And Importance In Drug Design

Explore how Isothermal Titration Calorimetry empowers drug discovery, as well as learn about ITC fundamentals, how to eliminate weak candidates, and how to optimize development decisions.

How To Choose The Right CDMO For Your Project: Part One

Choosing the right CDMO is crucial for the success of your pharmaceutical project. Find out how to strike the ideal balance between an organization's technical expertise, facilities, and efficiency.

Observations That Can Be Avoided With The Right Software Partner

FDA 483 findings frequently cite a lack of data integrity, process adherence, and quality control. See why these issues persist and the significant risks they pose to pharmaceutical manufacturers today.

Digital Twins: A Game-Changer Throughout The Pharmaceutical Lifecycle

Uncover how end-to-end digital twins and Integrated Process Models are transforming manufacturing to enhance flexibility, accelerate time-to-market, and enable real-time decision-making.

Optimizing CMO Partnerships

Gain insight as experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

4 Signs That It's Time For DataOps

Examine when it’s time to integrate innovative solutions into your tech stack, as well as learn how DataOps and industrial data orchestration can drive ROI and streamline manufacturing operations.

Key Considerations For Dry Powder Inhalation

A focus on spray-drying expertise in pulmonary and nasal powder development highlights why it is vital to choose the right CDMO.

Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing

Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

De-Risking Early Phase Micronization With Integrated Solid Form Selection

Review a case study describing the selection of the optimal solid form of an API designed for pulmonary administration through the pulmonary route.

Partners For The Planet: Sustainability Review

In this report, read about concrete examples of projects across a global network that are contributing to the successful achievement of sustainability goals and aspirations.

FEATURED EDITORIAL

Audit Trail Compliance And What To Look For In Mitigation Software

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

SOLUTIONS

Be A Gain Changer With 2x Throughput

Easy-To-Use, Universally Compatible Automation Software Platform

All Inspection Information In One Convenient Source

Containment Equipment For CDMOs

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