Newsletter | September 21, 2026

09.21.26 -- Managing Immunogenicity In Subcutaneous Delivery

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PMWC 2027 Program Is Live

PMWC 2027: The program is live. Explore 15 focused programs spanning next-generation therapeutics, AI and computational medicine, precision diagnostics, and integrated precision medicine. Co-hosted by Stanford, UCSF, and Yale, PMWC features leaders including David Baker, Emmanuelle Charpentier, Andrew Ng, Fei-Fei Li, and Mary-Claire King, January 27-29, 2027, at the Santa Clara Convention Center.

FEATURED EDITORIAL

Managing Immunogenicity In Subcutaneous Delivery

The Immunogenicity subteam within The Subcutaneous Consortium discusses the impact of immunogenicity in biotherapeutics product development. They consider degrees of desired or acceptable immunogenic response and report on efforts at industry harmonization of assays employed in preclinical and clinical modeling. 

 

Oligonucleotide Delivery To Neuromuscular Targets

Emerging therapies are being designed to safely deliver oligonucleotides to disease-relevant tissues. Delivery is no longer a technical hurdle to overcome but a strategic lever.

INDUSTRY INSIGHTS

 

Sterile Filling Readiness In The Drug Device Delivery Ecosystem

Explore how adaptable technologies and strategic partnerships help navigate Annex 1 compliance and technical hurdles to ensure the successful delivery of complex drug products.

 

Optimizing Drug Delivery Through Smarter Substance Utilization

Optimize drug substance use during fill/finish. Learn how advanced line configurations and 100% non-destructive weight checks mitigate process drift, protect therapeutics, and prevent product loss.

 

A New Approach To Dual-Chamber Drug Delivery

A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.

 

Expanding Opportunities For Inhaled Drug Delivery

Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

 

Sustainability In On-Body Delivery System Platforms

Assimilate how our on-body delivery system supports high-volume biologic delivery by balancing usability, patient needs, and sustainability through research-driven design.

 

Supporting Manufacturing For Liquid And Lyophilized Drug Products

Advanced fill-finish technologies improve drug delivery by preserving product integrity, enhancing sterility, maximizing yield, and supporting scalable liquid and lyophilized formulations.

 

Ophthalmic Drug Delivery: Meeting Modern Challenges

Ophthalmic injectable packaging demands early strategic attention. Learn how silicone oil contamination, particulate limits, and dosing accuracy challenges can derail development programs.

 

The Story Behind MIDBA: An Exclusive Interview - Ypsomed

A new regulatory framework reduces PK bridging study needs, helping sponsors streamline device transitions, lower costs, speed up timelines, and boost regulatory predictability for combination products.

SOLUTIONS

Quality-Focused Strategies For Advanced Drug Delivery

Organ On A Chip: Advancing New Approach Methodologies

The Final Steps That Shape Drug Delivery Success

Choosing The Right CDMO For Drug Delivery Success