Advances and opportunities in process analytical technologies for viral vector manufacturing

Area of Science:

• Biotechnology and biopharmaceutical manufacturing
• Analytical chemistry and quality control
• Gene therapy and vaccine development

Background:

• Viral vectors are a rapidly growing class of biologics used in vaccines, oncology, and gene therapy.
• Hundreds of viral vector products are in development for treating monogenic and orphan diseases.
• Manufacturing these advanced therapeutics requires robust analytical methods to assess critical quality attributes (CQAs).

Purpose of the Study:

• To provide an overview of current analytical techniques for measuring viral vector CQAs.
• To evaluate the suitability of these methods for process analytical technology (PAT).
• To identify gaps and propose opportunities for real-time monitoring in viral vector biomanufacturing.

Main Methods:

• Review of orthogonal analytical methods for assessing viral vector identity, titer, transduction efficiency, and impurity clearance.
• Discussion of the advantages and limitations of existing techniques.
• Evaluation of adaptation strategies for PAT implementation.

Main Results:

• A diverse array of analytical techniques are currently employed for viral vector CQA assessment.
• Orthogonal methods offer comprehensive characterization but present challenges for real-time application.
• Existing technologies show potential for PAT adaptation with further development.

Conclusions:

• Advancements in analytical techniques are essential for the expanding field of viral vector therapeutics.
• There are significant opportunities to develop real-time monitoring capabilities for viral vector biomanufacturing.
• Addressing hardware, software, and data analysis gaps will enable more efficient and controlled manufacturing processes.