Newsletter | July 16, 2026

07.16.26 -- What Biopharma Often Overlooks In A Scheduled Shutdown

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Best In Class – Small Molecule API

The CDMO Leadership Awards are based on feedback from biopharma sponsor companies and independently analyzed by Tufts Center for the Study of Drug Development. MilliporeSigma is proud to announce their distinction as 2026’s Best In Class CDMO for Technology Use in the development of Small Molecule API. To learn more about how they can help with your next small molecule development project, click here.

INDUSTRY INSIGHTS

Walk-Away Monitoring Of Cytotoxicity, Viability, And Apoptosis

Real-time cell health monitoring reveals how drug dose and timing impact apoptosis, necrosis, and viability. Explore how automated workflows help pinpoint mechanistic toxicity windows.

Moving Beyond OEE To Operational Intelligence

OEE provides a high-level view of equipment performance, but it doesn’t explain the root causes. See why manufacturers need deeper insight to turn utilization metrics into meaningful improvements.

Extrusion-Based ASD Scale-Up: Performance Through Understanding

Review the formulation and manufacturing considerations for amorphous solid dispersions (ASDs), with a focus on hot melt extrusion (HME) as a scalable and cost-effective technology option.

FEATURED EDITORIAL

What Biopharma Often Overlooks In A Scheduled Shutdown

Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

INDUSTRY INSIGHTS CONTINUED

Advanced Process Development And Manufacturing Solutions

Scaling complex chemical processes requires early risk identification, integrated safety and analytical expertise, and efficient tech transfer.

Increase Agility By Integrating Drug Substance And Drug Product

Biopharma success depends on agility. Move efficiently from discovery to delivery by co-locating drug substance and drug product operations, reducing transfer risks and accelerating your timeline

Big Pharma Rethinking Resource Recovery Strategies

Here, we provide systematic methods to increase return on investment. Discover the seven primary investment recovery channels.

Smarter By The Second Redefining Pharma Biopharma Manufacturing

Continuous monitoring is transforming manufacturing. With advanced analytics and sensor technologies, teams can detect issues early and optimize processes in real time for greater efficiency.

Native SEC-MALS Characterization Using A Chromatography Data System

Native SEC‑MALS offers a calibration‑free way to accurately characterize peptide oligomers, helping scientists distinguish true higher‑order structures while avoiding bias.

UK Regulatory Reforms

Stay ahead of the evolving UK regulatory landscape and leverage upcoming reforms to accelerate patient access, drive innovation, and strengthen your position in the medicines development market.

Secondary Packaging: Inspection, Brite Stock Bottle Labeling, And Cartoning

Gain insight into a coordinated, around-the-clock approach that demonstrates how packaging efficiency can keep pace with urgent pharmaceutical launches and tight commercialization timelines.

Optimizing Bioprocesses Using Functional DOE

Combining Functional Design of Experiments (Functional DOE) with traditional DOE methods enhances process optimization by capturing dynamic, time-based variations in cell culture systems.

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.

Process Re-Design For Sustainability In Small Molecule Manufacturing

Examine the optimization of the manufacturing process of a pharmaceutical intermediate, as well as how yield can be improved substantially via suitable reaction engineering.

A Practical Guide To Expanding Across Sites While Staying Compliant

Standardizing governance and data foundations is critical for scaling multi-site networks without increasing risk. Learn to leverage reusable validation and harmonized workflows for audit readiness.

Bridging The Gap: How Process Knowledge Moves From Lab To Launch

Delve into how life sciences innovators use industrial data fabrics to eliminate manual tech transfer errors, bridge departmental silos, and accelerate time-to-market.

Safeguarding Quality In Parenteral Drug Manufacturing

Find out how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

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Building Inspection-Ready Systems with Digital Documentation

Join Chief Editor Katie Anderson and her expert panel on July 29, 2026 at 11 AM ET. for a special Pharmaceutical Online Live discussion: Building Inspection-Ready Systems with Digital Documentation. The discussion will focus on how digital documentation is reshaping inspection readiness and offer actionable insights on moving from reactive inspection preparation to a sustainable state of continuous readiness through digital transformation. Registration is free thanks to Thermo Fisher Scientific.

SOLUTIONS

How To Verify PFS System Performance

Extremely Versatile, Small-Footprint Blow/Fill/Seal Packaging Machine

Polymer Processing Capabilities

Artificial Intelligence's Potential In Pharma Manufacturing

Flow Cytometry Solutions

Turn Regulatory Readiness Into An Operational Advantage

A Fast And Simple ddPCR Assay For In-Depth AAV Characterization

Dynamic Pass Boxes And Dynamic Floor Laminar Hatches

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