Newsletter | September 23, 2025

09.23.25 -- Gedatolisib Shatters Phase 3 Goals And Scales For Breast Cancer Breakthrough

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Webinar: How Digital Cleaning Validation Can Simplify Audit Readiness and Improve Compliance

Don't miss this Ecolab webinar on transforming cleaning validation with digital tools. Learn how to build a robust, inspection-ready program that goes beyond outdated spreadsheets. Discover smarter ways to identify worst-case products, set MSC limits, and streamline processes. Gain actionable strategies, timelines, and real-world insights to confidently transition your cleaning validation program into the digital era. Click here to learn more.

INDUSTRY INSIGHTS

Exploring The Potential Of Agentic AI

Discover how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.

Scale-Up And BLA Planning For Microbial Biomanufacturing

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

Combining Rapid And EP Bioburden Testing

Review a procedure in which compendial testing is complemented by a simultaneous rapid test that uses an identical sample to generate much earlier results while allowing the compendial test to continue.

FEATURED EDITORIAL

Gedatolisib Shatters Phase 3 Goals and Scales For Breast Cancer Breakthrough

After unprecedented phase 3 clinical trials of gedatolisib, Celcuity is working feverishly with its partners to get the drug ready to offer a new standard of care to those that suffer from advanced breast cancer.

INDUSTRY INSIGHTS CONTINUED

The Ultimate EBR Guide: Solutions For Smart Manufacturing

Learn about smart manufacturing and how connected, electronic batch records enable smarter and more efficient manufacturing capable of addressing current and future production challenges.

Enabling Complexity: Drug Substance Manufacturing Via Continuous Flow

As molecular complexity continues to increase, flow chemistry is becoming an essential enabling technology to facilitate the integration of complex synthetic methods into API production.

AI-Assisted Spatial Proteomics Of Immune Cells In Alzheimer's Brain

AI-driven multiplexed imaging reveals neuroimmune interactions in Alzheimer’s disease, identifying immune cell subtypes near pathological hallmarks like Β-amyloid plaques offering therapeutic insights.

Big Pharma Rethinking Resource Recovery Strategies

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

Vial Containment Systems

Explore the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.

Ensuring AI Compliance In Life Sciences: 5 Critical Requirements

Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Uncover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

Use Of Reconstructed Tissue And 3D Printed CT-Based Nasal Casts

Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in manufacturing by detecting and fixing equipment issues before failure.

New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology

Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative delivery methods. Biodegradable polymers show promise in addressing these challenges.

Downstream Strategies To Accelerate Preclinical Development Timelines

As recombinant protein-based products accelerate toward IND, reliable process development methods are critical to meet demand. Review case studies to see how expedited timelines can be achieved.

Small Scale, Big Impact: The Advantages Of Flexible Pilot Plant Equipment

Gain insight into the benefits of flexible pilot plant equipment. Seamlessly scale up your processes, optimize your formulations, and save costs with in-house small-volume production.

Key Offerings To Help Support Your OSD On Its Journey To Market

Discover several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.

Microbial Air Sampling: Physical And Biological Collection Efficiencies

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.

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Developing new delivery routes for biological therapies is vital for more patient-centric, effective treatments. In this webinar, we explore how nanoforming simplifies dosing, improves comfort and compliance, and may reduce healthcare costs. One case shows nanoformed Trastuzumab enabling a stable, concentrated subcutaneous formulation with improved syringeability. Another highlights nanoformed Semaglutide as an inhalable dry powder, demonstrating deep lung deposition. These examples show how nanoforming can transform biologic delivery, enhancing both efficacy and patient experience.

SOLUTIONS

A Solution Taking Single-Use Filtration To Manufacturing Scale

Capacity Update: Small Molecule Drug Substance/API

Advanced Product Inspection Technologies For Pharma And Biopharma

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

The Ultimate Solution For Your Chromatographic Separations

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