Newsletter | September 15, 2026

09.15.26 -- AI Governance Is Just Like Driving A Race Car

SPONSOR

Webinar: Breaking the Concentration Barrier: New Long - Term Stability and PK Data for Subcutaneous Nanotrastuzumab

High-dose biologics can make SubQ delivery challenging due to viscosity, stability, and injection volume limitations. Discover how Nanoform’s nanoparticle engineering technology enabled an ultra-high concentration trastuzumab suspension at 440 mg/mL, delivering 75% lower injection volume and promising stability and pharmacokinetic performance. Explore the potential for more patient-centric, low-volume SubQ therapies. Click here to learn more.

INDUSTRY INSIGHTS

The Importance Of Reliable Mixing In ITC Experiments

Explore how Isothermal Titration Calorimetry (ITC) precisely analyzes molecular interactions, which provides thermodynamic data to understand physiological processes and develop new strategies.

Bridging The Gap Between Product Readiness And Equipment Availability

Discover how manual precision at scale bridges packaging gaps, accelerates product launches, and ensures uninterrupted supply to deliver quality when automated equipment isn’t yet operational.

Advancing ADCs With Expertise In Payloads And Linkers

Uncover how integrated containment, high-potency expertise, advanced chromatography, and proven linker–payload process optimization can accelerate your ADC program.

FROM THE EDITOR

AI Governance Is Just Like Driving A Race Car

Though some skeptics remain, nearly every business is at some stage of AI adoption. The technology has proven applications in pharmaceutical manufacturing, but effective governance must keep pace with its rapid development. That challenge is familiar to Bill Reid, healthcare and life sciences lead in Google’s Chief Information Security Office (CISO).

INDUSTRY INSIGHTS CONTINUED

Moving Beyond Known Targets

A pioneering perspective shows how new scientific thinking, physics‑based insights, and bold leadership are expanding the druggable universe and opening therapeutic paths once thought impossible.

Preventive Maintenance Isn't Enough For GMP Manufacturers

Schedule‑based maintenance supports compliance but misses real‑time asset risk. See how GMP manufacturers are moving toward condition‑based and predictive strategies to modernize asset management.

The High Intensity Sweeteners Neotame And Sucralose

Learn how high-intensity sweeteners can mask bitter aftertastes and support patient adherence, with practical guidance on stability, safety, dosage-form applications, and market perception.

Improved Cell Viability For Multi-Day Cell-Based Assays

Ensure consistent cell health and assay reliability with controlled temperature and gas conditions. Delve into how microplate readers with gas mixers enhance cell viability in live cell-based assays.

The Hidden Cost Of Tracking Requalification On Paper

Take a look at the hidden compliance risks of tracking inspector qualifications on paper, as well as how automated tracking ensures continuous audit readiness across all operations.

Why Spray Drying Is Gaining Attention

Facing patent cliffs, pharma companies can leverage spray drying to reformulate complex biologics, enabling non-invasive delivery, boosting patient convenience, and securing new patents.

From Undocumented Space To Strategic Asset

Transform undocumented facility space into a dynamic digital model. Accelerate expansion planning, streamline vendor alignment, and optimize process flows with verified spatial data.

From Assessment To High-Concentration Formulation Development

Gain insight into a strategic approach to accelerating biologics formulation by gaining early insight into molecular properties and optimizing high-concentration conditions with minimal protein input.

Designing An Environmental Monitoring Solution For GMP Applications

Implement robust contamination control strategies that align with current regulatory requirements. Optimize your environmental monitoring framework through precise design and data-driven analysis.

Precision By Design: Drug Innovation Through Structure-Based Drug Design

Leverage structure-based drug design to gain deeper molecular insights, prioritize high-potential candidates, and accelerate your path from discovery to clinic.

Managing Supply For Complex Biotherapeutics

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.

A Direct Path To Annex 1 Compliance With Blow/Fill/Seal Technologies

Read about how Blow/Fill/Seal technology supports contamination control, reduces operator risk, and meets sterility assurance requirements under dynamic conditions with advanced airflow and monitoring.

SPONSOR

Pharmaceutical Online, Federal Equipment and Techceuticals bring you Virtual Pharma Expo - a themed event featuring presentations by leading experts from pharmaceutical equipment providers for oral solid dose manufacturing and packaging.

SOLUTIONS

Reach New Heights In Performance

An Organ-Chip Platform That Generates Human-Relevant Data At Scale

Highly Precise Cross-Speed Capsule Filling Machine

The Ultimate Solution For Your Chromatographic Separations

Capabilities Update May 2026: Highly Potent Drug Development

Labeling For Form, Fill, And Seal Machines

Capabilities Update July 2026: Large Molecule

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