06.25.24 -- Assassination By Implication? Interview With WuXi AppTec (Part 2)

When Business of Biotech last caught up with Brian Culley, CEO of Lineage Cell Therapeutics, it was January 2021. A pandemic was raging. His company was moving mountains to keep its OpRegen dry AMD clinical trial together. On his return, Culley opens up on how the company addressed struggling programs, wrestled manufacturing control issues and delivery inefficiencies in its spinal cord program to the ground, and maintained control of its regulatory progress along the way. Listen.

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Review an optimization process that increases the yield of plasmids, the precursors for mRNA synthesis, and achieves a scalable, efficient process for high-quality mRNA production.

Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

As critical raw materials for viral vector production, plasmids are in high demand. Finding an experienced, GMP-grade plasmid supplier can mitigate risk and yield reliable results.

The objective of this study was to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Flowfect technology.

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates.

While clinical efficacy is the critical benchmark for any drug program, manufacturability is also vital. An experienced CDMO can help you establish efficient, cost-effective production strategies.

This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.

Explore how a partnership between academia, regulatory agencies, and manufacturers has the potential to reshape the way we produce and distribute mRNA-based therapies.

CAR-T cell therapy has been limited by high costs and lengthy manufacturing. Novel methods are bringing exciting advancements in CRISPR-based gene editing that hold promise for overcoming hurdles.

Our Philadelphia Campus serves as a centralized hub for collaboration, supporting companies throughout the CGT pipeline, from initial research to commercial-scale manufacturing.

As cell and gene therapies continue to transform modern medicine, Cryoport Systems evolves its products and solutions to meet the needs of the industry and the patients it serves.

Explore our end-to-end, customer-centric CDMO services that are helping to bring more breakthrough treatments to patients.

A one-stop solution for your cell therapy needs can help ensure efficiency, cost-effectiveness, and faster patient treatment. Our Draw-to-Thaw® service streamlines the entire process.

We are setting a new standard with well-characterized induced pluripotent stem cell (iPSC) lines that are suitable for research, clinical and commercial use.