Newsletter | February 27, 2024

02.27.24 -- Shaping A Digitally Enabled Commercialization Road Map

NEW PODCAST EPISODE

Inside Yescarta's Reduced Median Turnaround Time With Kite Pharma's Christopher McDonald

On Cell & Gene: The Podcast, Christopher McDonald, global head of technical operations at Kite, a Gilead company, talks about their recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. Hear about the significant steps Kite Pharma took to reach this approval.

FEATURED EDITORIAL

Shaping A Digitally Enabled Commercialization Road Map

For cell and gene therapy companies, it is critical for commercial, marketing, and digital leaders to understand key business decisions that shape the digital backbone of their commercialization road map.

INDUSTRY INSIGHTS

Strategies To Address The Viral Vector Manufacturing Shortage

Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

2023 Technology Adoption Trends And Plateaus

About 85% of industry leaders and managers have had some exposure to AI. Delve into the state of AI adoption experienced throughout 2023 and where the industry is headed concerning digital tool usage.

Balancing cGMP And BSL-3 Regulatory Requirements

Find the right solutions for your organization to comply with and maintain product quality and safety despite conflicting cGMP FDA 21 CFR Part 210 and 211 cleanroom and BMBL requirements.

High Efficiency T Cell Editing

Explore a modified synthetic sgRNA that allows you to achieve efficient, multigene knockout in primary human resting CD4+ T cells.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

mRNA-LNP Nucleic Acid Assessment From Distinct Formulations

Review a showcase of a high throughput robust analysis for nucleic acid integrity and size assessment of mRNA-LNP samples using a multi-capillary system and purity and integrity analysis kit.

Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges

Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.

Precision Volume Accounting In Fed-Batch Cultures

Are you searching for a better way to calculate growth rate? Explore a new approach that performs the rate calculations using a simple method to correct for volume changes.

Assay For Rapid Lot-Release Testing In Cell Therapies

Learn how PCR-based mycoplasma detection assays can provide a rapid alternative to culturing with comparable sensitivity, specificity, and species range that can facilitate quick decision-making.

SOLUTIONS

Streamline Process Development With Eppendorf DASbox

Quantify Multiple Targets With The QX600 Droplet Reader

MauriceFlex: A Novel Platform For icIEF Fractionation

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