Cynthia A. Challener

Weighing development costs/resources and performance benefits is essential.

Collaboration between technology providers and biopharma manufacturers are enabling both evolutionary and novel developments.

Platform processes and effective risk assessments help overcome time and cost challenges.

Gamma irradiation is being supplemented with alternative technologies.

Using a multi-pronged strategy to find optimum, tailored formulations is best.

Sterile filtration and use of sterile single-use materials provide the best solutions depending on vector size.

Increases in efficiencies, flexibility, scalability, and sustainability are impacting adoption.

Proprietary cell lines offer opportunities for achieving high AAV titers.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

Developing freeze-drying processes requires patience and deep product and process understanding.