09.18.25 -- Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond

Uncover why leveraging strong scientific expertise and comprehensive testing techniques will be vital in expediting development and upholding the integrity of these life-saving treatments.

AAV has become an increasingly popular vector for gene therapy applications, yet ongoing challenges related to process and analytical development often require significant expertise to navigate.

Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

For the robust manufacturing of the serotype AAV6, the Pro10™ production platform has proven reliability and scalability, making it suitable for meeting the demands of large-scale manufacturing.

Consider how the following strategies can be used to optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

Examine how a mission-driven partnership is breaking barriers in cell and gene therapy to deliver faster, affordable access to life-changing treatments for underserved global communities.

Explore our novel ddPCR method for assessing plasmid-derived antibiotic resistance gene impurities in rAAV products to enhance regulatory compliance and ensure the safety and quality of gene therapy vectors.

Leverage our proven cGMP expertise in cell therapy manufacturing, from primary tissue processing to large-scale production for clinical trials.

Design of Experiment (DoE) methods streamline the development of robust, phase-appropriate potency and functional assays, ensuring testing that supports scalable cell therapy development.