Newsletter | March 14, 2023

03.14.23 -- 4 Lessons Learned Developing Cancer Immunotherapy Treatments

Featured Editorial
Industry Insights
Viral Quantification: Adeno-Associated Virus Vector Genome Titer Assay

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

Preparing For The Commercial Scale Production Of Cell Therapies

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

De-Risking CGT Therapies In Process Development For Success And Savings

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.

Why Pairing Decentralized Trials With Pharmacies Results In Better Participant Access

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.

Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?

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?

Challenges And Solutions In Cell And Gene Therapy Manufacturing

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

DMSO-Free & Serum-Free Cryopreservation For Cell And Gene Therapy

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).

Innovation, Tech, And Collaboration In Advanced Materials

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.

mRNA Product IVT Process Insights

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.

Implement Rapid Process Changes In Gene Therapy Manufacturing

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.

Taking Your Advanced Therapy From Clinic To Commercialization

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.

Optimizing Storage And Distribution In An Era Of Clinical Trial Transformation

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.

Rare Cell Isolation

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

Data Integrity And Compliance: What Every Lab Should Know

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.

Considerations To Accelerate The Path To Clinic For mRNA/saRNA Manufacturing

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.

Mitigate Clinical Holds And Achieve Successful CGT Outcomes In Early Drug Development

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.

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