Newsletter | July 10, 2025

07.10.25 -- Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

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Enabling Subcutaneous Delivery For Improved Patient Compliance

The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens. Discover how Nanoform Biologics’ innovative approach to high-dose subcutaneous delivery of biologics addresses the challenges of traditional SC delivery methods.

INDUSTRY INSIGHTS

Regulatory Compliance And Audits For Parenteral Manufacturing Precision

CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.

Spray-Dried Bevacizumab: Treating Non-Small Cell Lung Cancer

The development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

Digital Transformation In Contract Manufacturing: A Leadership Perspective

Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.

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.

How To Unlock The Secret To Repeatable, Scalable Low Turnover

Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

A Guide To CRO, CMO, And CDMO Partnerships

By partnering with a reputable CDMO, biotech and pharmaceutical companies can leverage their expertise and resources to expedite the development and manufacturing of life-saving medications.

Small Surface Decontamination: A Best Practice Guide

Elevate your contamination control strategy with best practices for small surface disinfection, from product selection and application techniques to ensuring consistent, validated results.

X-Ray Inspection For Supplement Safety

Wellington Foods ensures dietary supplement safety using an X-ray system that detects contaminants and meets regulatory standards with high-speed, precise inspection technology.

Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing

Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.

Digital Solutions For Accelerated Innovation

Hear how Applied Biosystems AccuSEQ software serves as an advanced digital tool that can help streamline bioanalytical processes and accelerate the delivery of life-changing therapies.

Advancements And Considerations For Fill-Finish Processing

When it come to fill-finish manufacturing of parenteral liquid pharmaceuticals, your choice of barrier technology is crucial.

Patient- And Planet-Centric Bioavailability And Sustained Delivery

By reducing the size of drug particles, nanoforming offers new opportunities — from increased bioavailability to sustained drug delivery. Explore the potential benefits supported by case studies.

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Webinar: Navigating the CMC Regulatory Landscape during Protein Medicinal Product Development and Manufacturing

This webinar outlines the evolving CMC regulatory landscape for protein-based drugs, from preclinical to post-market stages. Through case studies, it shows how Lonza supports clients with integrated regulatory services. Key takeaways include the value of strategic planning, adapting to varied agency expectations, and partnering with experienced CDMOs to ensure regulatory success. Click Here to learn more.

FEATURED EDITORIAL

Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

SOLUTIONS

The Ultimate Solution For Your Chromatographic Separations

Dry Powder Inhaler Services

Bioprocess Automation Software Solutions

Cleaning And Disinfectant Bucket System For Manufacturing

Quality, Data, And Analytical Solutions

Advancing Vaccines From Preclinical Development To Commercial Supply

Capacity Update January 2025: Small Molecule

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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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