02.17.25 -- Building Frameworks To Support Complex Therapy Manufacturing

To prevent path-to-market setbacks, it is critical to develop a CMC strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

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.

Reducing risk while maximizing API volume is critical during the fill/finish phase of biopharmaceutical manufacturing. To secure safety and quality, partner with an experienced fill finish provider.

Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

Ensure the safe, reliable, and future-ready delivery of gene therapies with cutting-edge temperature-controlled logistics solutions.

Monoclonal antibodies (mAbs) stand as pivotal drug products and biochemical reagents in the 21st century. Explore how mRNA-encoded antigens could revolutionize antibody discovery.

Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.

Establishing the safety and efficacy of cell and gene therapy treatments necessitates rigorous quality control. See how an outsourcing partner can help you deliver safe, efficacious therapies to patients.

Examine how a partnership leveraging expertise in production for high-quality CRISPR gRNAs as well as cGMP manufacturing is supporting the clinical translation of CRISPR genome editing technologies.