Newsletter | December 5, 2025

12.05.25 -- ISPE Awards 8 Innovative Pharma Facilities

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Lessons Learned from FDA 483s and Warning Letters – Strengthening GMP Cleanroom Compliance in Life Sciences

Join AES Cleanroom Technology experts as they reveal critical lessons from FDA 483 observations and Warning Letters tied to GMP cleanrooms in the life sciences industry. Through real-world case studies and regulatory insights, attendees will learn how to prevent common compliance failures, strengthen contamination control, and design resilient, inspection-ready facilities aligned with cGMP requirements. Click here to learn more.

INDUSTRY INSIGHTS

A Complete Guide To Capsule Checkweighing

Understand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.

Calcium Carbonate As TiO2 Alternative In Coating

Explore how calcium carbonate can replace titanium dioxide in tablet coating, as well as learn formulation strategies and review color performance data to support high-quality finishes in applications.

Modern Control Systems Enable Step Change Improvements

Modern control systems are helping manufacturers improve traceability and streamline compliance. Learn how digital tools are simplifying migration and enabling smarter, more connected operations.

FROM THE EDITOR

ISPE Awards 8 Innovative Pharma Facilities

The Facility of the Year Awards (FOYA) celebrates 20 years of innovation and excellence in 2025, and I had the pleasure of joining the celebration at the 2025 ISPE FOYA Banquet and Awards Celebration on Oct. 26, 2025.

INDUSTRY INSIGHTS CONTINUED

The Advantages Of Blow/Fill/Seal Processing For Vaccine Production

Multicomponent filling and sterilizing systems represent unique advantages for vaccine production. Read how B/F/S systems can be adapted for vaccine production without incurring any product degradation.

Driving Robust Tech Transfer In Biologics: CFD Simulation

Computational Fluid Dynamics simulation is essential for robust biologics tech transfer. See how this predictive tool optimizes critical scale-up processes, reducing risk and expediting time to market.

From IND To NDA: The Role Of The Kilo Lab In A Seamless Scaleup

To derisk your manufacturing, work with an outsourcing partner that prioritizes the kilo lab as a space to develop a proven, robust, and reliable workflow from clinical to commercial scale.

How Two Life Science Leaders Unlocked Pharma 4.0 Success

Gain valuable insights from digitalization leaders on how some life sciences manufacturers are successfully scaling their Pharma 4.0 initiatives beyond the pilot stage and paving the way forward.

DPI Blister Filling: From The Original Invention To The Latest Technology

Discover how a novel compression technique eliminates vacuum-related contamination and sealing failures in DPI blister manufacturing, leading to a cleaner, more accurate filling process.

Accelerating Antibody-Drug Conjugate (ADC) Development

Find out how automated immunoassays help overcome ADC bioanalysis challenges, reducing hands-on time, improving throughput, and enabling multi-analyte workflows for more efficient assessments.

Rheological Behavior Of Lactose And Carboxymethyl Cellulose In Excipients

Explore lactose monohydrate and CMC rheology, highlighting their flow, cohesion, and compressibility properties to optimize pharmaceutical formulations under varying stress and temperature conditions.

The Future Of Compliance, Efficiency, And Data Integrity

Uncover how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

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.

Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It

Learn how thorough cleaning and process optimization in pharma manufacturing prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance.

Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements

Examine how a mobile cGMP cleanroom on a 53′ tractor-trailer chassis was designed and installed to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

Simultaneous Spray Drying: Dry Powder Inhaler Combination Formulations

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Discover how novel techniques can make these products a reality.

Not Your Typical MES: The Ultimate Guide To Made With MX

Gain insight into how digital transformation is revolutionizing production processes to enable personalized medicine and improve patient outcomes across the healthcare industry.

Unlocking A Patient Preference For Rapid Onset In Treating Migraines

Review the case study to reveal how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter Tmax for the treatment of acute migraine.

SOLUTIONS

Biodegradable Polyester Amide Platform For Sustained Delivery Solutions

Pionyr: Selecting A CDMO To Scale-Up Manufacturing

Transform GMP Data Into Actionable Intelligence

Two-Side Labeler For Challenging Product Shapes

Pharma Services Fill, Finish, And Drug Delivery CDMO

Early Drug Development Made Easy With Small Quantities

An Innovative Isolator For Fill/Finish Applications

Capacity Update October 2025: Small Molecule

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