Newsletter | October 22, 2026

10.22.26 -- Building A Product The Market Can Sustain

SPONSOR

From Insights To Impact: Predictive Models And PAT For More Efficient And Robust Biologics Manufacturing

Bringing a biologic from cell culture to commercial vial requires precise, data-driven scale-up strategies that maintain product quality, process consistency, and supply reliability. Biological variability, engineering constraints, and critical quality attributes must remain balanced throughout development. Drug product formulation, particularly lyophilization, adds further complexity, influencing stability, shelf life, efficiency, and cost. This webinar explores predictive modeling and Process Analytical Technology enable deeper process understanding, real-time control, and informed decision-making across drug substance and product manufacturing.

INDUSTRY INSIGHTS

CDMOs - Key Collaborators In Streamlining Drug Development

Accelerating biologics development requires more than speed. Discover how the right CDMO partnership can streamline processes and help you reach the market faster without sacrificing control.

How This CDMO Model Is Empowering Emerging Biotechs

For emerging biotechs looking to refine their development processes and boost their chances of commercial success, exploring these partnership opportunities could prove invaluable.

LYO Cycle Development Ensures Success For Oncology Drug Scale-Up

An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.

FEATURED EDITORIAL

Building A Product The Market Can Sustain

From formulation and packaging to partner selection, early outsourcing decisions help determine whether a medicine can reach patients at a cost the market can sustain.

Setting Your MES Up For Long-Term Success

Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

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.

Developing Non-PEG Stabilizer Lipids For Nucleic Acid Lipid Nanoparticles

Non-PEG stabilizer lipids may offer a new path for LNP design. Combining strong colloidal performance with greater chemical flexibility helps address growing concerns around PEG-related immunogenicity.

What It Takes To Lead Quality With Helen Bickley

Quality is no longer just about compliance. See how a unified, data‑driven quality mindset supports scalable manufacturing, reduces variability, and helps organizations meet expectations.

Advancing Formulation Strategies For Complex Drug Products

An event-focused overview examining how formulation development and stability strategies support robust, scalable drug products discussed at the DDF Summit Berlin.

Raw Material Planning For Tech Transfer And Scaling Biologics

Join this roundtable of biopharmaceutical professionals as they share their insights to help you navigate important quality and planning decisions for the progression of your biologic.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

Expanding Subcutaneous Design Brick By Brick

Biologics are growing more complex. But what if the syringe itself could unlock new possibilities? Discover the technology “bricks” quietly reshaping subcutaneous drug delivery.

Licensed Vs. Unlicensed Cell Lines In Biologics Development

Choosing licensed vs. unlicensed cell lines impacts development speed, cost, flexibility, and long‑term control, making early strategic evaluation key to efficient biologics development.

SPONSOR

Join us on October 27 for Driving Biologics Manufacturing Innovation and Fill-Finish Excellence. Explore the technologies, capabilities, and strategies shaping both biologics and sterile drug product manufacturing. Leading CDMOs will discuss cell line development, fermentation, purification, sterile filling, lyophilization, packaging, and quality oversight, helping sponsors evaluate manufacturing partners, navigate scale-up and technology transfer, and prepare for successful clinical and commercial production.

SOLUTIONS

Where Dedication Delivers Value

Mississauga Site Wins

Advancing ADC Development From Cell Line To Commercial Supply

Your Global Network For Mammalian Cell Culture Manufacturing

HEK293 Transient Production

Laboratory Services

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

Connect With Outsourced Pharma: