Cell & Gene therapies (CGT) or advanced therapeutic medicinal products (ATMPs) are innovative medicines developed to treat cancers, rare diseases, autoimmune disorders and injuries. As these therapies utilise living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.   

Cell & Gene Therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat diseases such as cancer, rare diseases, and autoimmune disorders.

Those therapies, based on living cells, have short shelf lives, are available in low volumes and cannot be sterilized by filtration or irradiation. Microbiological examination of cell-based products is critical to ensure safety prior to patient infusion.

Download this application note by Dr Megha Bajaj, Global Solution Manager at bioMerieux, to discover more about:

• The relevancy of in-house isolates in microbiological QC testing

• The selection and implementation of in-house isolates

• Common microorganisms isolated in pharma labs.

Automated Incubation and Reading versus Visual Inspection

USP chapter <1116>1 describes Environmental Monitoring (EM) as a key element to ensure  control of aseptic processing areas. The quality of the drugs manufactured is directly linked to the capacity to minimize microbial contamination. 

The Tecan Fluent® workstation has been paired with the bioMérieux ENDOZYME® II GO pre-coated plates to create a seamless automation solution for endotoxin testing.

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

The pharmaceutical industry is highly regulated in a number of ways. One of them is Qualification and Validation. But what are we talking about? Why do we talk about Qualification AND Validation? What does this apply to? What tools accompany these approaches? How are they deployed?

Pharmaceutical manufacturers use feasibility studies to ensure the solution they would implement (equipment, system, process…) meet their expectations in compliance with highest standards.

As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings.