Newsletter | July 15, 2025

07.15.25 -- 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies

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Webinar: Revolutionizing Cell Metabolism Monitoring: Inline, Real-Time Glucose and Lactate Analysis

This PHC webinar explores how real-time, inline monitoring of glucose and lactate using PHCbi’s LiCellMo® technology can transform bioprocessing and cell therapy. Learn how continuous metabolic analysis improves cell viability, reduces variability, and accelerates decision-making—overcoming the delays and inconsistencies of traditional sampling methods to enhance product quality in biopharma, regenerative medicine, and academic research.

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7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies

The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

Cell Collection Basics For The Transplant And CGT Industries

Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.

Ancillary System Integration For Closed Cell Therapy Manufacturing

The material and packaging requirements for CGT are undoubtedly unique. Uncover how platforms are being established to support the specific needs of this industry. 

Benchmarking Filtration Performance Of TFF Cassettes

Optimize your protein purification workflow with tangential flow filtration by comparing membrane performance and exploring how protein concentration impacts flux and MWCO selection.

PSC Perfusion Guidance Using Vertical-Wheel Bioreactors

Unlock the potential of perfusion for pluripotent stem cell cultures. Explore key insights into achieving improved consistency and quality in your medium exchange protocols, leading to better outcomes.

FAQs On The Revised EU GMP Annex 1: Volume 2

Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

Rev-Up AAV Genome Production In Upstream Manufacturing

By increasing recombinant AAV titers, this AAV enhancer can help reduce upstream manufacturing costs and lower the cost per therapeutic dose.

Get Full Control Of Your T Cell Isolation

This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.

Delving Into Modular Cleanroom Designs For Drug Manufacturing

Explore the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

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Cell & Gene Therapy International (September 16-18, 2025, Boston) unites 300+ industry leaders and 50+ expert speakers to transform breakthrough science into life-changing treatments. Explore three specialized tracks covering manufacturing, analytics, supply chain, and emerging technologies—all designed to accelerate your therapies from development to patient access. Don't miss this premier gathering of CGT innovators. Register with code VERT10 to save 10%

MANUFACTURING SOLUTIONS

Streamline Viral Vector And Vaccine Development - Thermo Fisher Scientific

Acoustic Liquid Handlers For Assay Miniaturization - Danaher Life Sciences

Omics In Health - Battelle

A Platform For Continuous Glucose And Lactate Control - Repligen – PAT

A Benchtop System For Lipid Nanoparticle (LNP) Formulation - KNAUER

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