Newsletter | December 15, 2025

12.15.25 -- 4 Key Challenges Slowing Advanced Therapy Progress—And How to Overcome Them

Four Challenges That Stall Advanced Therapy Development

By working to optimize many challenges in an advanced therapy's development, drug developers can prevent issues before they arise and avoid the rework and delays that can torpedo timelines and derail development. Find how to foster a better development strategy.

 

AAV Analytics: Key Considerations When Developing A Clinical Program

Inadequate analytical development and process validation pose challenges for advanced therapies. Finding expert partners with the skills to optimize AAV processes is crucial for minimizing variability and risk. See key considerations for advancing your AAV gene therapy.

 

A Proven AAV Platform To Drive Down Program Costs And Maximize Speed

Cell and gene therapies are increasingly popular vehicles for treating rare diseases. However, viral vector expertise is hard to come by and can make a difference in advancing a therapy to market. As you search for the right CDMO to manufacture your AAV therapy, start early and place a major premium on previous experience.

 

Optimization-By-Design — A Critical Factor In Viral Vector Scale Up

Inadequate preclinical planning and process development can stall advanced therapy development, preventing patients in need from receiving treatment for serious or life-threatening diseases. Leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using DoE, thereby reducing risk.

 

SOLUTIONS

Partnering With You From Preclinical Through Commercial Scale

Andelyn Biosciences is your full-spectrum gene therapy partner. Work with us from start to finish of your product or partner with us at any stage of your project – preclinical through commercial scale.

 

Manufacturing Life-Saving Gene Therapies

Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.