The pharmaceutical industry has traditionally relied on a transactional CDMO partnership, which, while adequate for some development programs, is insufficient for the complexity of adeno-associated virus (AAV) development and manufacturing.
A more collaborative partnership, starting at the proof-of-concept stage, is essential. This early engagement enables process alignment and leverages a CDMO’s broad experience to institute systematic quality risk management, which leads to a more clinically robust product.
In addition to mitigating risk, a collaborative approach to AAV development can also shorten program timelines. By providing consultative guidance sooner, a CDMO can optimize molecular design for manufacturability, enabling a hardy target product profile (TPP) from the start. Identifying manufacturable vectors, stable process conditions, and buffers early, using…
Complete the form to access the full PDF and discover practical strategies for accelerating your gene therapy program.
Transforming AAV PDF
Please fill in the form for access to the download.
"*" indicates required fields