Newsletter | February 3, 2026

02.03.26 -- Novo's Path To The First GLP-1 Weight Loss Pill

SPONSOR

Webinar: Selecting a Prefillable Syringe System with Confidence

While drug developers finalize formulations, packaging engineers face a complex, time-consuming path to syringe selection and testing. This webinar introduces the West Synchrony™ S1 Prefillable Syringe System — a fully integrated, verified solution from a single supplier. Learn how this innovation simplifies combination product requirements, reduces risk, saves time and resources, and accelerates your path to clinical fill and submission. Click here to learn more.

INDUSTRY INSIGHTS

EU GMP Annex 11: Compliance Strategy And Digital Solutions

Explore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.

Advanced Analytical Tools To De-Risk Pharmaceutical Development

Discover three tools that facilitate a successful journey from candidate compound to clinical triumph: solid form screening, PBPK modeling, and AI-enabled route scouting.

Why Established Pharma Sites Need A Digital Cleaning Validation Strategy

Pharmaceutical facilities face mounting pressure to modernize. Uncover how digital tools are transforming cleaning validation to boost compliance and audit readiness without disruption.

FROM THE EDITOR

Novo's Path To The First GLP-1 Weight Loss Pill

The race to the finish line for the first oral GLP-1 treatment for weight loss was won on Dec. 22, 2025, when the U.S Food and Drug Administration (FDA) approved oral Wegovy by Novo Nordisk as the first daily, oral GLP-1 pill for weight management.

INDUSTRY INSIGHTS CONTINUED

Six Benefits A Biotech Should Expect From Their CDMO Program Team

Whether a biotech is emerging or established, a dedicated CDMO program team offers invaluable support through effective communication, regulatory guidance, and adaptability to changing needs.

The Evolution Of Biotech And CDMO Partnerships: A 2026 Outlook

By integrating R&D and GMP teams early, developers can navigate complex formulation challenges and ensure a seamless transition from first-in-human trials to late-stage clinical manufacturing.

How To Approach Brazil's Regulatory Compliance

Companies seeking access to the Brazilian market must navigate more rigorous regulatory requirements, increased scrutiny, and heightened enforcement of good manufacturing practices.

Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow

Examine a high-efficiency workflow for generating GFP-expressing CHO-K1 clones using automated single-cell dispensing to achieve 93% isolation success and stable expression in under five weeks.

The Future Of Aseptic Manufacturing: Compact And Advanced Solutions

Space constraints and sterile integrity drive the shift toward modular, robotic manufacturing. Discover how adopting compact, automated systems reduces energy overhead and contamination risks.

CDMO Partnerships: Why Speed And Flexibility Matter Now More Than Ever

As demand for GLP-1s and biologics accelerates and timelines compress, it's become more crucial that companies stay competitive and bring therapies to market faster by partnering with a CDMO.

Real-Time Facility Monitoring For Quality And Compliance

As particle counting instruments evolve, opportunities to implement real-time quality control strategies arise, enabling the reliable production of high-quality drugs without excessive regulatory oversight.

Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs

Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

Wrap-Around Labeler For Small Vials, Cartridges And Syringes

Gain insight into a reliable solution for labeling small batches of medical products, including vials, syringes, and cartridges, that fully automatic machines struggle to handle.

SOLUTIONS

From The Floor At CPHI 2025: Takeaways Everyone Should Know

Solid Form Services

Enabling The Delivery Of Complex Biologics With Ergonomic Solutions

High Voltage Leak Detection Systems For BFS Vial Cards

Trusted Replacement Parts And Dedicated Service Solutions

Simplify The Journey With A Combination Product Solution

Environmentally Controlled Stability Storage And Testing Solutions

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