Newsletter | March 18, 2025

03.18.25 -- Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies'

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FOCUS ON MANUFACTURING

Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies'

The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

Quantifying And Assessing Cleaning And Disinfection Residues

Ensure your ATMP facility meets the latest Annex 1 standards for cleaning and disinfection residue control with the help of practical guidance and a case study detailed in this presentation.

4 Factors To Consider When Scaling Up

It's essential to understand how scaling up is affecting your aseptic filling operations. Here are four topics to consider to help ensure your drug product will be taken care of and ready for production.

Improving The Efficacy Of T Cell Therapies

CAR-T cell therapy is evolving rapidly, with scientists exploring new ways to improve efficacy, safety, and applicability. Precision media formulation plays a key role in optimizing therapeutic cell quality.

Cell Culture Media Change Protocol

Keep your cells thriving. Learn the essential cell culture media change protocol, including frequency, steps, and tips for optimal cell growth. Discover best practices and avoid common pitfalls.

Simpler, Faster, Cheaper Advanced Therapy Manufacturing

Discover how TFDF-based perfusion technology boosts lentiviral vector production by over 10-fold, slashes costs, and accelerates the commercialization of CAR-T and other advanced cell therapies.

Toward A Gene Therapy Platform: What's The Best Format Of TFF?

Evaluate tangential flow filtration (TFF) formats and membrane chemistries for AAV gene therapy processing, assessing performance, scalability, economy, and closed processing options.

Optimizing Safety Measures For rAAV Therapies

Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.

Engineering An AAV Platform For Superior Titer And Capsid Integrity

Learn how to optimize AAV manufacturing with a transfection reagent and enhancer platform that boosts titers and percent full capsids by 2- to 10-fold, featuring insights from real-world case studies.

A New Tool For Rapid Analysis Of Large Viral Vectors

Optimize your viral vector characterization with an instrument that features a semiautomatic workflow, enabling you to analyze samples of adenovirus and lentivirus within minutes.

Optimizing AAV Purification for High Recovery

How can you improve purification methods for your AAVs and enhance the efficacy and safety of your gene therapy treatments?

Empowering Biopharma With Single-Use Cryopreservation Solutions

Explore four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications.

MANUFACTURING SOLUTIONS

Thermal Ramping Characterization Solution: Aurora TX - RedShiftBio

BD FACSDuet Premium: Sample Preparation System - BD Biosciences

Modern MES Software For Drug Manufacturing - MasterControl, Inc.

Process Trains For Flexible, Configurable Biopharma Manufacturing Capacity - Cytiva

Pore Morphology And Pre-Filters - Entegris, Inc.

Accurate Aseptic Aliquoting Of Small Volumes - Single Use Support

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