Newsletter | April 7, 2026

04.07.26 -- Ever Wonder What Running A $50B Capital Facilities Project Feels Like?

SPONSOR

EU&PICS Annex 1: CCS short falls after 2 years of implementation

This advanced webinar explores Contamination Control Strategies (CCS) to meet EU GMP, PIC/S Annex 1, and ICH Q9(R1) expectations. Learn how to build CCS through three lifecycle stages, perform risk-based assessments using FMECA models, and reduce subjectivity. Real case studies highlight audit readiness, regulatory compliance, and operational improvements across sterile manufacturing, ATMPs, early development, and CDMO environments. Click here to learn more.

INDUSTRY INSIGHTS

Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

Drug developers must successfully navigate the path to market, under the growing pressure of regulation and competition, and while carefully managing technical and financial risk.

Moving Batch Release Into The Fast Lane

Complex supply chains and fragmented systems slow batch release, delaying patient access and revenue goals. Learn how automation and centralized data improve compliance and accelerate delivery.

Scale-Up And Production Of Key Lipids Used In mRNA Delivery Systems

Discover key strategies for overcoming challenges in the industrial-scale production of ionizable and PEG lipids to optimize mRNA vaccine formulation and address critical manufacturing requirements.

FEATURED EDITORIAL

Ever Wonder What Running A $50B Capital Facilities Project Feels Like?

Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.

INDUSTRY INSIGHTS CONTINUED

Scaling For The GLP-1 Revolution: Meeting Global Injectable Demand

To keep pace with surging GLP-1 demand, pharma needs partners that can rapidly scale injectable production while maintaining flexibility, quality, and regulatory rigor.

Round Tablet Compression Tooling — To Key Or Not To Key The Punches

What makes the keying in tablet compression tooling, specifically in tablet punches, so important to the tablet manufacturing processes?

Why Manual QbD Leads To Delays, Errors, And Ongoing Frustrations

Manual QbD methods slow timelines and increase risk. See how intelligent, digital frameworks are helping CMC teams improve quality, accelerate submissions, and meet rising regulatory expectations.

Re-Thinking ASD Development: When Your Molecule Breaks The Rules

A solvent‑free, fusion‑based approach streamlines amorphous solid dispersion development, enabling rapid early screening, improved performance, and sustainable manufacturing.

The Role Of IV Bag Inspection In Drug Manufacturing

Advanced IV bag inspection technologies ensure patient safety and regulatory compliance. Read more about automated leak detection and quality control innovations to optimize your business.

USP <665> Compliance Guidance

Experts address key USP <665> questions, including risk assessment, testing approaches, extractables and leachables, and practical challenges in implementing single‑use systems in manufacturing.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

A Cloud-Based Computational Protocol To Detect Adventitious Viruses

Advanced NGS bioinformatics pipelines and curated viral databases enhance the detection of adventitious agents. Examine how cloud-based protocols ensure rigorous safety assessments.

Integrated Single Site Model

A fully integrated single‑site model unifies development, manufacturing, formulation, fill‑finish, and quality oversight to reduce handoff risk and speed progression from API to sterile drug product.

Installing Herma Labeling Machines To Meet Stringent Requirements

To accelerate COVID-19 vaccine production, a leading biologics contract manufacturer sought high-speed labeling machines that could be rapidly deployed.

SPONSOR

Join Pharmaceutical Online Chief Editor Katie Anderson and experts for this virtual event, Proactive Contamination Control in Aseptic Fill/Finish. They will explore topics such as risk-based facility and equipment design, advanced barrier technologies, personnel and material flow optimization, environmental monitoring trending and data analytics, and the integration of rapid microbiological methods. Registration is free!

SOLUTIONS

In-Silico Modeling Services

Advancing Health Through Decades Of Packaging Innovation

Life Science Tools Reimagined

AAV Production: Your AAV CDMO Partner, Every Batch, Every Milestone

Computer Software Assurance (CSA) And Computer System Validation (CSV)

How To Implement PUPSIT Without The Pain

Ensuring Stability And Accuracy Of Powder Weighing Tasks

Achieve A Versatile, Closed Aseptic Environment

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