05.31.23 -- Improving The Speed, Efficiency, And Outcome Of Your Project Through Fit-For-Purpose Quality Management

Evaluating quality attributes is essential for ensuring a reliable pDNA supply for successful development and manufacturing. Examine the benefits of considering quality attributes early in the drug product life cycle and how an experienced manufacturing partner can offer flexible, comprehensive support along the full development path to commercialization journey.

The demand for plasmid DNA (pDNA) manufacture to support the clinical development of advanced therapies has never been greater. Defining a scope of work with a CDMO to deliver pDNA material for clinical supply needs requires careful consideration to meet the requirements of the regulatory body.

Australia's competitive advantages include a highly developed medical innovation ecosystem, globally recognized and aligned regulation, favorable incentives to support medical manufacturing, proximity to Asian markets to facilitate export, and close ties with global pharmaceutical markets.

Customized project management is indispensable to cater to every client’s unique requirements, particularly within the innovative and dynamic gene therapeutics space. Examine how project management and integrated, cross-functional project teams are key qualities to look for in a CDMO to ensure continuous alignment of goals toward the delivery of fit-for-purpose pDNA.