Newsletter | February 21, 2024

02.21.24 -- Creative Solutions To Optimize Cold Chain Logistics

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Webinar: Accelerating Rare Disease Treatments From Concept To Cure

The swift progression from gene discovery to mass vaccination in the development of COVID-19 vaccines set a remarkable precedent. This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey. Click here to learn more.

FEATURED EDITORIAL

Industry Experts Find Creative Solutions To Optimize Cold Chain Logistics

How can companies improve their shipping systems, cryogenic preservation, and courier selection to keep their products viable and fully traceable from manufacturing facilities to patients?

CMC Comparability

Dr. Nicole Verdun shares some of the challenges of demonstrating CMC comparability during late-stage product development (i.e., pivotal or Phase 3 clinical trial) that occur while transitioning to commercial manufacturing.

INDUSTRY INSIGHTS

Practical Applications Of ICH E6(R3): What Do We Need To DO?

Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

Effects Of Annex 1 Revisions On Manufacturing Operations

Revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some key takeaways and interesting changes for risk management and contamination control strategies.

Harnessing mRNA As A Readout To Develop Robust BioPotency Assays

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.

Opportunities To Accelerate Allogeneic Cell Therapy

Learn more about the potential of allogeneic cell therapies to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.

3 Services Your Biopharmaceutical Supply Chain Partner Should Offer

Uncover why finding an experienced partner dedicated to reducing the risk of contamination and capable of growing with you as the project advances through clinical trial stages is essential.

Reflecting On ElevateBio’s First Five Years

This is an exploration of highlights and accomplishments in each area of our businesses over the past five years, accelerating our company to where we are today.

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As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create standardized manufacturing. Join Cell & Gene Live for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation. Registration is free thanks to the support of Entegris.

SOLUTIONS

CRISPR/Cas Nucleases Product Guide

HLA Testing: Comprehensive Genotyping For Human Leukocyte Antigen

Cell And Gene Capacity Update October 2023

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