Newsletter | September 4, 2025

09.04.25 -- AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies

SPONSOR

Webinar Series: Managing Method Variability - A Foundation for Risk-Based Change

Join us for a three-part webinar series featuring regulatory expert Peter Baker of Live Oak QA, a former FDA Investigator of the Year. This series explores how to identify, monitor, and control variability within analytical workflows, offering real-world insights and practical strategies for method adjustment while staying compliant. Each session includes a live Q&A to encourage interaction and address specific challenges. Register now

INDUSTRY INSIGHTS

Unlock The Power Of Biophysical Tools In Biotherapeutic Development

Unlock innovation in biotherapeutics with expert insights into DSC and molecular stability. Learn how biophysical techniques can optimize formulations and enhance nucleic acid stability.

A Driving Force For Advanced Cleanroom Standards

Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

How To Solve Complex Pediatric Dosing Challenges Using Tailored Solutions

With a partner who understands the science, the regulations, and the real-world demands of dosing children, development can move faster, smarter, and with greater confidence

Unlocking Agility And Efficiency In Biomanufacturing

Discover a standardized yet flexible modular biomanufacturing system designed to accelerate timelines, improve scalability, and enhance quality while reducing costs and environmental impact.

Pursuing Automation Excellence With A Comprehensive Solution

Automating your bioprocessing workflows can significantly improve quality and scalability. To reap the benefits, implement plant-wide control software that enables seamless integration and efficiency.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Navigating Regulatory Compliance: A Success Story In The Pharma Industry

Reveal how one pharmaceutical facility overcame strict cross-contamination rules and space limits without costly building modifications to ensure operational continuity.

Innovative Softgel Technologies To Deliver Poorly Soluble Molecules

Read how to expedite the development pathway for early-phase compounds and how lipid-based formulations provide an innovative approach to enhance bioavailability for challenging molecules.

Streamline Drug Development With A Lab Informatics Platform

Learn how a tiered approach to ADME-Tox studies can help researchers navigate early-stage preclinical research and mitigate the risk of costly failures in drug development.

Annex 1 Compliance Guidelines For Biological Indicator Users

Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.

Enabled Form Selection For Oral Drug Products

Review the role of solid form screening and PBPK modeling to enable accelerated timelines desirable in early-phase drug development. Examine formulation maps for ASDs and key criteria for salt screening.

DataOps For Manufacturing: A 4-Stage Maturity Model

Explore a maturity model that was created to help you better understand where you are on your DataOps journey and where you need to go to achieve the results you expect.

Leveraging SPR For Characterizing Ternary Complexes

Uncover how Surface Plasmon Resonance (SPR) can be used to gain real-time, label-free insights into PROTAC binding kinetics and ternary complex formation.

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Webinar: Innovation & Efficiency - Visual Inspection in the 21st Century

Join InQuest Science's webinar with Roy Cherris, a leading expert in visual inspection systems, as he shares 40+ years of Quality Assurance expertise. Learn how to optimize visual inspection efficiency, reduce errors, and achieve compliance with FDA and global guidance. Discover how Identifier Software enables paperless Pharma 4.0, consolidates big data, and transforms Quality by Design through digital relational databases. Click here to learn more.

FEATURED EDITORIAL

AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies

A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

SOLUTIONS

Quality Management And Compliance Consulting

Advancement Of Upstream Bioprocess Intensification

Manufacturing Solutions

A State-Of-The-Art Syringe Liquid Sampler

Services Designed To Take You From Molecule To Market

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The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year's theme, Microbial Resilience: Today's Response, Tomorrow's Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future.

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