Microbiological quality control of short-shelf life Cell and Gene Therapies (CGTs) or Advanced Therapy Medicinal Products (ATMPs) including CAR-T cell therapies can be challenging, as generally they need to be administered before the results of a standard compendial sterility test are available. Therefore, CGT manufacturers have to consider implementing faster, quicker, and more efficient alternative approaches. These can be for raw material testing, environmental monitoring, or final product release.

What are the Advantages of RMMs for ATMP Manufacturers?
RMMs can offer several advantages over traditional methods, including:

• Faster time to results: RMMs can significantly reduce the time required for microbial detection, with less hands-on time - faster release of therapies gives improved patient outcomes.
• Increased sensitivity: RMMs can detect a wide range of microorganisms compared to traditional methods, enhancing the safety of cell and gene therapies.
• Accuracy: Instrumentation can deliver standardized, accurate, objective results with built-in data integrity and chain of custody.
• Improved workflow efficiency: RMMs can automate many steps in the detection process, reducing labour costs and improving overall efficiency.

While Rapid Microbiological Methods (RMMs) offer numerous benefits, their application in the manufacturing of CGT products presents unique challenges.

• Validation: Validating RMMs for use in CGT manufacturing can be complex and time-consuming, requiring extensive testing to ensure accuracy and reliability. Ensure your chosen supplier can offer the technical support you will need.
• Regulatory Compliance: Adhering to changing regulatory standards for integrating RMMs into manufacturing processes is essential, again your supplier should be able to offer some support.
• Sample Complexity: Samples from cell and gene therapy manufacturing processes can be complex and heterogeneous, RMMs need to be robust enough to cope and sensitive enough to detect to required limits.
• Data Integrity: Ensuring data integrity and traceability when using RMMs is essential for compliance and quality control efficiency but can be challenging in the context of rapid microbial method instrumentation.
• Cost Considerations: Implementing RMMs may require initial capital investment in equipment and staff training.

The first step for any gene therapy procedure is to have adequate and accurate DNA samples. Puritan’s line of DNA-free, DNA-Controlled collection devices are available in many tip and handle styles, and with a choice of tip fibers.

Discover bioMérieux’s proven portfolio of value-added solutions in their video, showcasing use of 3P^® ENTERPRISE to digitalize and automate Environmental Monitoring (EM), BIOFIRE^® Mycoplasma PCR for 1 hour Mycoplasma results, BacT/ALERT 3D instrument for real-time rapid sterility results, ENDOLISA^® based on ELISA and Recombinant Factor C (rFC) which helps complex biologics overcome BET limitations, the Accelix platform is an automated easy to use flow cytometry for cellular viability phenotyping, potency, and purity.

Microview offers the BioAerosol Monitoring System (BAMS) (also available from Cherwell in UK and Ireland), differentiating between biological particles (such as contaminating microbes) and inert ones (such as dust particles) with enhanced precision. The BAMS delivers contamination alerts in real-time.

Redberry's Next-Generation Solid-Phase Cytometry (SPC) detects microorganisms in cell-based therapies within a day, this technique's efficacy has been validated on various cell types, including HeLa, Jurkat, Stem, CAR-T, and CHO cells.

Download Sartorius' application note on comparing results from using Microsart^® ATMP Bacteria and Microsart^® ATMP Fungi Real-time PCR kits with the compendial sterility test.

With so many endotoxin tests on the market how can you select the most suitable one for your samples? In this exculsive rapidmicrobiology interview, Timothy Francis and Delaney Novak, Technical Specialists, LAL Division of FUJIFILM Wako, will guide you to making the right decisions for your particular situation.

Plus, reduce your time to result with the Milliflex^® Rapid System 2.0 for faster sterility and bioburden results.

Strengthen Cell & Gene Therapy Production with Smart Quality Testing

Developing Cell and Gene Therapies presents many challenges. Adding rapid and easy-to-use solutions to your operations brings overall efficiencies to the manufacturing process through both simplified workflows and fast, accurate, actionable results to ensure patient safety.
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Microbiological Same-day Results for Cell and Gene Therapy Products

Redberry is pleased to announce a significant improvement in the microbiological testing of cell and gene therapy products. Our recent research, conducted jointly with key players in the ATMP domain, has led to a faster detection method that provides same-day results, thus enhancing patient safety.
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Rapid ATMP Testing Speeds Up Sterility Release

Rapid tests for ATMPs cut down sterility and mycoplasma detection times, safely fast-tracking therapies to patients. For a comparison of Microsart^® ATMP Bacteria and Microsart^® ATMP Fungi Real-time PCR kits with the compendial sterility test, download the application note.
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Are You Using the Right Endotoxin Method for Your Samples?

How do you select and validate the most suitable endotoxin testing method for your particular needs? In this rapidmicrobiology interview, Timothy Francis and Delaney Novak, endotoxin testing Technical Specialists at Fujifilm Wako's LAL division, share their knowledge and expertise.
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A Way to Reconcile Early Release of ATMPs and Microbial Safety

A combination of rapid sterility and rapid bioburden testing can increase manufacturer confidence that short-life products, such as cell and gene therapeutics, will be microbiologically safe for release. Both rapid methods can be performed on the same platform after a linked validation procedure.
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Puritan^® DNA-free and DNA-controlled Specimen Collection and Transport Devices

Puritan’s line of DNA-free and DNA-controlled swabs and transport devices have you covered for quality sample collection and transport to the lab.  
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BAMS Elevates Contamination Detection in Cell & Gene Therapy with Real Time Alerts

Discover how BAMS, the real-time biofluorescent particle counter, can transform environmental monitoring with continuous results and instantaneous alerts, aid root cause identification, and expedite clean room validation – all in a portable format.
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AMSBIO Launches GMP-Compliant StemFit™ iPSC Expansion Medium

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Maximizing Efficiency in Cell and Gene Therapy Manufacturing with BFPC Technology

Explore how BAMS technology revolutionizes cell and gene therapy manufacturing with real-time microbial monitoring, allowing for enhanced sterility and cost savings. Learn about the benefits of BFPCs in ensuring quality and safety standards.
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Improve Your Knowledge of GMP and Annex 1 Regarding ATMPs

In the training Advanced GMP for ATMPS on 2/3 July 2024, you will learn about the existing regulatory requirements for aseptic manufacturing, CCS, data integrity and lyophilization according to Annex 1. Various experts from authorities, industry and consulting will share their knowledge.
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SterilGARD^® e3 BioPharma Package Ideal for Cell and Gene Therapy and Personalized Medicine.

Meeting the compliance demands in biomanufacturing environments can be challenging.  Baker offers a variety of products and services, like the SterilGARD^® e3, to help support your quality management.
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Ingenza Expands CodABLE® Gene Design Algorithm for Recombinant Protein Production

Scottish CRDMO Ingenza will adapt its codABLE® machine learning platform for precise control of recombinant protein expression in Pichia pastoris, accelerating the development of therapeutics, enzymes, and other proteins by fine-tuning codon usage and maximizing production yields.
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European Society Gene and Cell Therapy (ESGCT) 31st Annual Congress

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ATMPs and Microbiological Related Issues

This virtual meeting will focus on microbiological challenges associated with the manufacture of these fascinating and life-changing groups of products. Including CCS for facilities, viral vector, and final product manufacturing both in Europe and the US, and operator qualification.
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Implementing a Robust Viable EM Program

In this event, we will highlight the essential components of a viable sampling program and discuss key elements that an organization should consider when developing its program. Abby Roth, a key figure in the field of environmental monitoring, will be sharing her valuable insights and expertise with us.
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