03.31.26 -- The Jones Act Hurts U.S. Pharmaceutical Manufacturing

Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

Successful cell therapy programs rely on evolving, science‑driven partnerships that integrate CMC strategy, deepen rigor over time, and translate complex research into clinically ready processes.

To ensure the success of gene therapy, learn why it is crucial to partner with a CRO that can navigate the challenges of viral vector development and testing.

Discover how our expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.

Adenoviruses are being reimagined as powerful tools for oncolytic cancer therapy, using their immunogenicity, tumor selectivity, and synergy with immunotherapy to drive new clinical progress.

Rapid, low‑cost checks can catch construct issues that limit vector manufacturing, enabling early fixes to improve titers, avoid delays, and accelerate gene therapy programs.

Progress in cell and gene therapy hinges on aligning therapeutic design with scalable, efficient manufacturing to improve accessibility, reliability, and real‑world feasibility across advanced modalities.

Eliminating discontinuity between R&D and cGMP manufacturing, through mirrored environments, accelerates the journey to IND and patient access and bypasses delays in clinical transfer.

Here, we highlight real-world applications of AI in gene therapy, providing case studies and addressing the challenges and prerequisites for successful implementation.

Explore virus strain selection and titer strategies to optimize viral clearance studies, covering regulatory expectations, study design, and execution best practices.