07.07.25 -- How AI Is A Game-Changer For Auditing Compliance And Efficiency

Review the pivotal moments, challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational, patient-focused CDMO.

Learn how to identify common CRO selection pitfalls and apply expert-backed strategies to protect your clinical program from costly risks and delays.

Discover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.

This study evaluates the performance and productivity of VintaProcess in addressing the persistent manufacturing challenges in AAV gene therapy production.

Gain insights into the significance of plasmid design in viral vector production and the use of analytical assays and Next-Generation Sequencing for plasmid verification.

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

By leveraging this innovative combination, the assay achieves detection limits comparable to traditional methodologies while enhancing overall efficiency and reliability.

Examine the factors that impact CGT timelines during the preclinical phase and offer actionable strategies to help ensure timely and cost-effective IND filing.

From identity and purity testing using chromatography and electrophoresis to PCR and microbial studies, explore advanced analytical solutions tailored for siRNA, miRNA, pDNA, and mRNA products.

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.

By implementing an efficient characterization strategy, researchers can enhance the consistency of allogeneic cell therapy starting material, ultimately leading to improved clinical outcomes.