Pharma Quality Control White Papers  

Download the white paper to learn about CAR-T cell therapy, which uses a patient’s own genetically modified T cells to target and kill cancer cells.

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.   

ENVIRONMENTAL MONITORING (EM) is one of the main microbiological controls that pharmaceutical industries perform to ensure the safety and efficacy of pharmaceutical products. To efficiently control the quality of these products, the presence of potential microbial contaminants must be monitored.

Although the traditional method is extremely manual, variable and error-prone, it remains the standard procedure used in industry for hundreds of millions of samples per year.

The BIOFIRE® Mycoplasma test is a closed-system sample-to-answer nucleic acid test that is designed to report the presence/absence of over 130 mycoplasma species in less than an hour. It requires minimal hands-on time and contains everything needed to run a molecular test in a sealed pouch.

This white paper discusses the challenges of one media/one temperature incubation, with a real case study and evaluates the sustainability of a single incubation temperature strategy for Environmental Monitoring.

Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process from both a safety as well as an economic point of view. Rapid and accurate identification of microorganisms can contribute to reduce cost and time linked to investigations and corrective actions. 

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.

Optimizing the control of bioproduction processes and the environmental monitoring of the biopharmaceutical industry is key to supporting the competitiveness of companies and no longer making quality control a bottleneck in the value chain of bioproduction but rather a real added value.

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).

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 SCANRDI® is a non-growth-based rapid microbial method (RMM) that detects not only viable microbial cells that can be isolated using a broth or agar plate but also viable but non-culturable (VBNC) microorganisms, including stressed and fastidious microorganisms that may not be recovered by standard culture methods, making SCANRDI® more sensitive than growth-based methods.

With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.

Recombinant horseshoe crab Factor C (rFC) methods are the latest state-of-the-art solution for effective bacterial endotoxin testing (BET). This whitepaper reviews the advantages of Recombinant horseshoe crab Factor C (rFC) over the BET methods currently in widespread use. We compare the performance of LAL reagents with rFC, and summarize the evidence supporting our 10 reasons to choose 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.

In microbiology and pharmaceutical development, environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection.

Drug developers rely on data quality management (DQM) during development and manufacturing for a number of reasons and, therefore, must start with a clear data management strategy in order to organize and protect the integrity of the products, along with the safety and well-being of patients.

This white paper reviews the causes contributing to low endotoxin recovery (LER), the impact it creates, as well as solutions which can rectify the issues it results in. We also discuss the advantages and disadvantages of developing your de-masking protocols in-house, and how you can use the ENDO-RS® de-masking tool kit to make the process easier from beginning to end. Following this, we outline the pros and cons of outsourcing your de-masking project, what you should look for in a third-party company, and why you can and should trust bioMérieux with your de-masking protocol development.

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.