Newsletter | September 11, 2026

09.11.26 -- The Complex Anatomy Of An ADC Tech Transfer

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Webinar: Design Verification Done Right: Smarter Strategies for Prefillable Syringes

Design verification for prefillable syringes can be challenging as regulatory expectations, drug-device integration, and testing requirements evolve. This webinar explores a risk-based framework for building a defensible verification strategy. Using a real-world case study, learn how to translate user requirements and product targets into test plans, acceptance criteria, and aging considerations. Gain insights to strengthen decisions and reduce ambiguity. Click here to learn more.

INDUSTRY INSIGHTS

 

Patient-Centric Formulations In Pediatric Adherence

Improving pediatric adherence requires age-appropriate formulations, taste-masking, and swallowability strategies. Regulatory, clinical, and technological insights help overcome barriers.

 

A Roadmap To Flexible, Efficient Biopharmaceutical Manufacturing

Modernizing biomanufacturing requires shifting from rigid, custom setups toward modular automation, data-rich sensors, and plug-and-produce operations. 

 

Building A Holistic Container Closure Integrity Control Strategy

Strong package integrity starts with a clear view of risk. Learn how science, validation, quality, and manufacturing considerations can work together to support a stronger CCI strategy.

FEATURED EDITORIAL

The Complex Anatomy Of An ADC Tech Transfer

Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

 

INDUSTRY INSIGHTS CONTINUED

 

Capabilities Update: HPAPI And API Development

What is critical when choosing a CDMO as a partner for HPAPI development and manufacturing? Brian Haney breaks down the key questions, controls, and expertise every innovator should evaluate.

 

Streamlining Biologics Development: Leveraging Small-Scale Studies

Uncover how a data-driven approach to small-scale studies not only accelerates development timelines but also enhances decision-making and resolves full-scale manufacturing challenges.

 

Predicting Softgel Stability And Shelf Life Using Accelerated Modeling

Predict ibuprofen softgel shelf life in 21 days. ASAPprime modeling identified PEG-ester degradants as the limiting factor, estimating 5.5-year and 3.8-year shelf lives before studies concluded.

 

Reflecting On 2025: Innovation & Investment

As capacity expands and capabilities mature, CDMOs with global scale and advanced injectable expertise are becoming critical partners for bringing complex sterile drug products to market.

 

SEDDS: Improving Oral Bioavailability Of Poorly Soluble Compounds

Nearly 90% of marketed drugs have poor water solubility. See how self-emulsifying drug delivery systems (SEDDS) resolve oral bioavailability failures across BCS Class II and IV compounds.

 

The Strategic Power Of Medical Device Coatings

Medical device coatings are shifting from basic finishes to strategic tools that boost performance, safety, sustainability, and innovation through stronger partnerships and smarter materials.

 

Prevention Of Product Recalls

Product recalls impact revenue and reputation. Implementing inspection systems like X-ray, vision inspection, and metal detection helps prevent contamination, ensuring high product quality.

 

Unlocking Efficiency In Large-Scale Microbial Manufacturing

Gain insights into how expert teams and the right tools help build resilience into manufacturing systems and tackle small, often-overlooked issues before they become costly problems.

 

How To Address Your Solid Dosage Processing Needs

Unlock the keys to consistent solid dosage products. Align unique product needs with optimal processing requirements and equipment strategies. Gain a roadmap for improved quality and reproducibility.

 

5 Key Questions On Implementing Pharma 4.0 Solutions For Fill-Finish

Pharma 4.0™ leverages IoT, AI, and automation to enhance drug quality. Evaluate your fill-finish line readiness by considering five key questions on modularity and high-risk process automation.

SOLUTIONS

Capabilities Update July 2026: Fill/Finish

Quality Drive + People Powered

Rapid System For The Early Detection Of Microbial Contamination

Two Decades Of Sterile Manufacturing Excellence

An Overview Of Our AI-Assisted Early Phase Toolkit

Cleanrooms For R&D And Testing Facilities

Supercharge Your Cleaning Routine

A Toolless, Removable Surface For Rapid Plate Replacement

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