Newsletter | November 29, 2023

11.29.23 -- Upstream Decisions That Ensure Downstream Success

SPONSOR

As additional mRNA-based cancer immunotherapies vaccines enter clinical development, operational and supply chain challenges must be addressed to reduce turnaround times and COGS. Join Cell & Gene Live on December 5th for a breakdown of ways to address uncoordinated and inefficient processes to promote greater stability and immunogenicity. This digital event is free to attend thanks to the support of Thermo Fisher Scientific.

FEATURED EDITORIAL

5 Takeaways From Meeting On The Mesa 2023

By Tyler Menichiello, contributing editor

This year's Meeting on the Mesa conference delivered outstanding networking, presentations, and panel discussions with industry leaders. Here are Contributing Editor Tyler Menichiello's favorite quotes from this year's participants.

INDUSTRY INSIGHTS

Can A Small Plasmid Produce Huge Benefits? The Power Of Small

Webinar | Aldevron

With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.

Monitoring Cord Blood Inventory Reliability By Key Quality Indicators

Poster | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises

Validated processing methods and storage conditions are the first steps toward providing a safe and effective product for transplant. Review a retrospective analysis of a final verification process.

Improving Access And Support For Cell And Gene Therapies

e-book | Cencora

Although cell and gene therapies (CGTs) are potentially transformative, their effectiveness is undermined by difficulties with patient access and support, high costs, and a complex pathway to treatment.

CGTs In The U.S. Vs. The EU: Top Five Areas Of Differentiation

e-book | Thermo Fisher Scientific

Review processes for companies hoping to gain market access through FDA or EMA approval, as well as tips for navigating the differences.

Critical Steps To Optimize Viral Vector Manufacturing With CDMOs

Article | By Ramesh Koukuntla, FUJIFILM Diosynth Biotechnologies

To develop a fruitful viral vector manufacturing process and a mutually beneficial relationship between sponsor and CDMO, learn to balance cost, quality, and timeline via transparent communication.

Pioneering Solutions That Turn Hope Into Reality

Webinar | Andelyn Biosciences

The number of AAV-mediated therapies in clinical trials continues to rise, increasing demand for doses. A scalable platform is crucial to ensure a seamless transfer from preclinical to commercial.

Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead Technology

Article | By Heidi Trusheim and Edward Fix, IDT Biologika

Scale up your manufacturing of adherent cell cultures used for viral vector-based treatments with the novel technologies needed to facilitate safe, rapid production.

4 Capabilities That Support A Superior Condition Monitoring Solution

Article | Cryoport Systems

CGT's time and temperature sensitivity requires advanced consideration for storage and distribution. Monitoring the location and condition of each shipment is crucial to ensure product safety and quality.

Overcoming Manufacturing Challenges For Advanced Medicines

Webinar | Project Farma

Watch as biopharmaceutical experts discuss the various obstacles teams face when leading the operations and manufacturing of advanced medicines and the strategies to overcome them.

Developing ddPCR-Based Analytical Methods For Cell And Gene Therapies

Article | By Anne Bickel and Karin Abitorabi, Minaris Regenerative Medicine

Employing ddPCR can optimize CGT manufacturing processes by providing reliable detection of vector copy numbers, ensuring that parameter changes during process development are correctly evaluated.

Making The Right Decisions Upstream To Ensure Downstream Success

White Paper | By Avi Nandi, Brian Tomkowicz, and Dana Cipriano, The Center for Breakthrough Medicines

Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.

SOLUTIONS

Plasmid Manufacturing

Ajinomoto Bio-Pharma Services

Viral Vector Packaging

Charles River

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