Newsletter | July 17, 2025

07.17.25 -- Bracing For The Impact Of The Federal Workforce Reduction

 

 

 

INDUSTRY INSIGHTS

 

Accelerate Biologics Product Release With Seamless Viral Testing

Uncover viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.

 

Navigating Global Regulatory Landscapes In An Evolving Industry

Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future trends.

 

The Essential Guide To Cleanroom Compliance

Ensure cleanliness and safety in your manufacturing by discovering cleanroom standards cards that simplify compliance with concise, essential information from major regulatory bodies.

 

Aligning CGMP With Precise Product Requirements

Partnering with an experienced sterile CMO is essential for small-batch injectables, requiring clear communication, quality alignment, and regulatory compliance to ensure manufacturing success.

 

Effects Of The Ongoing Pandemic On Bupivacaine HCI Supply

Throughout the pandemic, painkiller and sedative demands spiked. Drug manufacturers and CDMOs have become critical in efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.

 

Biopharma's Path To MES In The Cloud

The industry is shifting to cloud-based Manufacturing Execution Systems (MES). Discover how you can use a modern MES to enhance efficiency, collaboration, and compliance.

 

Improved GLP-1 Receptor Agonist Peptide Recovery

Find out how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.

 

Improve Facility Monitoring Systems To Comply With Regulations

A facility monitoring system is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime.

 

Scaling Up A Revolutionary Amorphous Solid Dispersion Platform

Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.

 

Innovations In Pregastric Absorption Drug Delivery And ODTs

Experts gain insight into permeation enhancers for drug absorption, PBPK modeling for formulation design, and fast-dissolving ODTs shaping drug development.

 

Catalent's Journey Of Continuous Improvement For CSV Excellence

Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

 

High Voltage Leak Detection For Parenteral Drug Container Closure Integrity

Medical and pharmaceutical products are often packaged in fluid-filled containers. Read more about CCIT using high voltage leak detection (HVLD), how HVLD technology works, and more.

 

Integrating Phase-Appropriate Quality Standards

Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.

 

Recent Innovations And Enhancements To Pharmaceutical Spray Drying

Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

SPONSOR

 

 

Get ready for ISPE's largest event of the year, the 2025 ISPE Annual Meeting & Expo, 26–29 October, in Charlotte, North Carolina, USA, and virtually. This year's theme is Pharma 4.0™, with sessions exploring the integration of digitalization across all stages of pharmaceutical processes. Attendees can explore the latest advancements, network with like-minded professionals, and discover new technologies. Learn more and register

FEATURED EDITORIAL

Bracing For The Impact Of The Federal Workforce Reduction

The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

 

SOLUTIONS

Pharmaceutical Automated Sample Handling System For Headspace Testing

Blow/Fill/Seal Packaging Systems

An End-To-End Compliance Platform For Pharmaceutical Manufacturing

The Buyer's Guide To Buffer Formulation Equipment

Best-In-Class Nanodevelopment Capabilities

Reliable Visual Inspection Equipment To Deliver The Highest Integrity

SPONSOR

 

 

Avoid costly missteps in small molecule batch production. Join Pharmaceutical Online Live for a free digital event exploring proactive contamination control strategies—from facility design and HVAC to isolator use and CDMO selection. Learn from expert insights on how to build an efficient, contamination-resistant process from the ground up. Sponsored by Particle Measuring Systems.

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