Newsletter | September 11, 2025

09.11.25 -- Minimizing The Impact Of Human Errors Using Relational Risk Analysis

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Webinar: From Compliance to Confidence: Annex 1 for Small-Batch, High-Value Production

Discover how to navigate GMP Annex 1 updates with confidence in this must-attend webinar. Former MHRA inspector Tracy Moore shares expert guidance on contamination control, monitoring, risk-based compliance, and reject handling for aseptic filling of small-batch, high-value products. Plus, see 3P innovation's live demo of roboFIL®, showcasing advanced automation for smarter, flexible, compliant fill-finish operations. Click here to learn more.

INDUSTRY INSIGHTS

Steps For Proper Cleaning Validation

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

How Pharmaceutical Companies Can Enable Agile Manufacturing

Pharma leaders face rising pressure to deliver personalized therapies faster and more efficiently. Discover how top companies are evolving operations to stay agile, compliant, and competitive.

FEATURED EDITORIAL

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

INDUSTRY INSIGHTS CONTINUED

Increasing Batch Size And Reducing Cycle Times For A Biologic

JHS partnered with a global pharma company to optimize biologic production, which increased output by 50% and reduced batch release times by up to 30%.

Overcome Common Pre-Filled Syringe Challenges Through Partnership

The pre-filled syringe space is one of the fastest-growing pharma sectors that offers greater patient safety. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.

Container Closure Integrity Test Method Development For Autoinjectors

Uncover an autoinjector technology that leverages laser-based headspace analysis for container closure integrity to advance biologic drug delivery with precision, safety, and regulatory confidence.

Recommended Mixing Equipment For Ophthalmic Preparations

In the processing of ophthalmic solutions, high-shear mixers are utilized for dissolving salts as well as dispersing viscosity enhancers, antioxidants and other additives.

Next Generation Sequencing In Viral Safety Testing

Next Generation Sequencing offers a sensitive, high-throughput solution for detecting adventitious viral agents to improve safety and accelerate regulatory-compliant product development.

Five Considerations For PUPSIT Implementation

Pre-use, post-sterilization integrity testing is vital for contamination control to ensure the integrity of sterilized equipment before use. Learn how PUPSIT can enhance safety and quality in your protocols.

How To Accelerate And Enhance ADC Therapies

Watch how payloads and advanced payload intermediates can expedite drug development and elevate ADC therapies, and explore ADC payloads, payload intermediates, and solubility-enhancing technology.

Combining Innovative Technologies For Precise Solid Oral Dosing

Find out how combining innovative technologies enables precise, individualized solid oral dosing—improving drug delivery, patient compliance, and therapeutic outcomes in applications.

"Ultra High” Potency Development And Manufacture

A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

De-Risking Your Bioconjugate's Path To Clinical Manufacturing

Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

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AAPS PharmSci 360 delivers research spanning the pharmaceutical pipeline, from discovery to manufacturing to delivery. Thousands of scientists and decision-makers from across the globe converge to discuss cutting-edge breakthroughs, technologies, and techniques at this science-first event. Join your colleagues for the latest in pharmaceutical science in San Antonio, Texas, November 9-12, 2025. Register today!

SOLUTIONS

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3D Modeling Of Facilities With Digital Twin Technology

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