03.09.23 -- How Robotics Will Scale CGT Manufacturing

The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 regulatory compliance.

Explore gamma, Ebeam, and X-ray sterilization modalities along with comparatives studies by leading academic and trade organizations, including the conclusions they draw on sterilization techniques.

Learn about the importance of cybersecurity for automated equipment, its weaknesses and risks, and how to mitigate for them by sensible practice and good system design.

Krabbe disease is a devastating neurodegenerative disease inherited in an autosomal recessive manner. Learn more about this disease and FBX-101, which utilizes adeno-associated viral (AAV) gene therapy.

A first-of-its-kind standard is a significant step forward in ensuring that irreplaceable therapies are always transported consistently, with an emphasis on compliance, validation, decontamination, traceability, and quality management.

While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.

Viral vectors are essential for delivering corrected genetic information to faulty genes within affected cells and are at the heart of the gene therapy process.

Embracing digital transformation, when combined with biomanufacturing best practices, supports increased productivity and efficiency in a biomanufacturing environment. Learn how distributed automation and digital plant maturity support resilient biomanufacturing.

Explore three perspectives on the capabilities and adoption of MAM workflows within the biopharmaceutical industry in addition to MAM resources for process and product control of biotherapeutic proteins.

Evonik Health Care's Dr. Martin Schilling and Johns Hopkins University Professor Michael Betenbaugh discuss advances and trends in cell culture-based production of biological drugs.

Expedited pathways have led to compressed CGT product development timelines, while guidance and regulatory standards continue to tighten and evolve as the industry matures. Review three tips for regulatory success.

Shoreline Biosciences' Chief Scientific Officer Dr. Robert Hollingsworth shares his insight on intelligently designed allogeneic off-the-shelf, standardized, and targeted iPSC-derived natural killers (NK) and macrophage cellular immunotherapies. He explains the company's preclinical testing on a potential NK cell therapy for acute myeloid leukemia. We discuss how the field recognizes the importance of off-the-shelf NK cell therapy not only for cost reduction but also for improving safety measures. As such, Hollingsworth talks through why NK cells necessary to move immunotherapies forward.

This webinar discusses how stakeholders across the drug development continuum can work together to manage availability and affordability, while reducing patient-adverse outcomes for these life-saving treatments.