03.14.23 -- 4 Lessons Learned Developing Cancer Immunotherapy Treatments

Learn about droplet digital PCR, how it is an improvement from quantitative PCR, and its precision determining AAV vector genome titers.

In this review, we discuss a few attributes that should be considered when planning manufacturing at scale for your cell therapy.

While the rigors of early process development in cell and gene therapy can appear burdensome for nascent companies, prioritizing certain early studies can mean the difference between success and failure for these highly sensitive drug products.

Sanskriti Tahkur, chief growth officer at Medable, outlines a path forward for the industry in addressing the diversity challenges it faces, using a combination of local pharmacy access and decentralized trial technologies.

You wouldn’t hire a house painter to retouch fine artwork, so why would you contract a jack-of-all-trades research organization to pilot a clinical trial with critical endpoints that require specific, in-depth expertise?

Discover the three major challenges cell and gene therapy manufacturers are facing today and insights on how to overcome them.

Learn about a completely defined, non-toxic cryopreservation solution ideal for cell & gene therapy and cell banking applications at ultra-low temperatures (minus 70°C to minus 196°C).

Demands for flexible, scalable, cost-effective manufacturing are prompting cell and gene therapy manufacturers and CDMOs to implement single-use technology for manufacturing their therapies.

In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.

A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

Explore the shifts in focus for quality systems and manufacturing processes, and highlight the importance of establishing long-term supply chains, starting with the end in mind.

Explore the rapidly evolving complexities of clinical storage and distribution and how customized and patient-centric solutions have never been more paramount to support the healthcare of tomorrow.

Learn how we perform rare cell isolation as a sequential, two-step process with a target frequency of less than 0.01%.

While FDA 21 CFR Part 11 allows life sciences organizations to use e-records in place of paper, a piece of software by itself cannot be compliant. Here's how to develop and perform GMP validation.

Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.

Listen in on this panel discussion to learn about the new and rapid innovations in cell and gene therapy development, regulatory guidance and best practices, mitigating clinical holds, and more.