10.07.25 -- What FDA's Complete Response Letters (CRL) Say About Outsourcing

Join Applied StemCell's webinar with Ruby Tsai, Ph.D., to explore how developers are tackling durability challenges in allogeneic cell therapies. Gain insights into approved therapies, treatments in clinical trials, and novel approaches still in development. Learn how genome engineering and iPSC technologies are enabling scalable, cost-effective solutions that could transform accessibility and impact in the future of cell-based therapies. Click here to learn more.

With real-world examples and a vision that challenges the prevailing norms of biotech commercialization, this conversation offers a powerful look at what it takes to reshape the future of healthcare.

Enhancing AAV production efficiency is critical for expanding gene therapy applications — this optimized helper construct significantly boosts yield and potency.

Here, we illustrate how our Design of Experiment (DoE) can accelerate development timelines, lower costs, and enhance decision-making across cell therapy programs.

Firelli Alonso, former and long-time Senior Director of External Supply at Pfizer, now industry consultant, provides an example of outsourcing in the CAR T space to demonstrate what can go right and wrong.

Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosted collaboration, visibility, and operational efficiency across teams.

See how this cutting-edge, AI-driven genome editing technology can accelerate the development of precise, clinically viable therapies for genetic diseases.

How one family managed to combine resources and people to get an investigational gene replacement therapy manufactured and approved by the FDA for their daughter just 14 months after her diagnosis.

Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.

Accelerate cell and gene therapy development with high-yield, regulatory-compliant plasmid DNA manufacturing that shortens timelines, minimizes risks, and streamlines your supply chain.

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

What does it take to bring an adenovirus-based therapy to the clinic – faster and without compromising quality? Find actionable insights to help improve efficiency and accelerate development timelines.

A high-performance, helper virus-free stable producer cell line is derived from proprietary high-producer HEK293 cells and is cultivated in a chemically defined, serum-free, ADCF medium in suspension.

This Touchlight and ElevateBio webinar explores how non-viral methods are transforming T cell engineering by overcoming cost, safety, and scalability challenges of viral transduction. Speakers highlight CRISPR-based editing with mbDNA™ paired with Life Edit’s LEG14 nuclease. Data show mbDNA™ enabled efficient, precise TCR knock-in with superior performance over Plasmid (next generation circular double stranded) offering a scalable path to next-generation T cell therapies. Click here to learn more.

When you need industry-leading technical support and components that help get your product to market quickly, choose 4031/45 Gray stoppers from the AccelTRA offer.

Translating mRNA sequence to a high-quality drug product presents a complex challenge, but partnering with a single contract manufacturer can alleviate potential delays and risks.

We offer a comprehensive range of assays to ensure the quality and safety of your cell lines. Our expertise in timely characterization is unparalleled, making us the ideal partner for testing.

Witness how NYBCe and CCS are transforming cell and gene therapy development with end-to-end CDMO solutions, advanced logistics, and a growing innovation hub in Louisville.

Our mission is clear: to help sponsors reduce costs, shorten timelines, and de-risk development, so they can achieve critical milestones, secure investments, and advance life-changing therapies.

Ready to go deeper on cell characterization? Advance past typical cell and donor screening to create a comprehensive immune cell profile for each donor.