This white paper provides an evaluation of BIOBALL^® MultiShot 550 Bcc range recovery levels on bioMérieux BCSA (Ref 33631) ensuring they are acceptable as per growth promotion and indicative properties testing requirements of USP <60> chapter.

This white paper details how innovative microbiological technologies are revolutionizing sterility testing for Cell and Gene therapy products. You'll learn the validation guidelines for alternative microbiological methods and gain understanding of the regulatory evolution and acceptance of rapid microbial testing.

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.

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.

Routine testing for microbial contaminants is a necessary part of ensuring biopharmaceutical product quality and safety. In this white paper, we describe the potential application of BIOFIRE FILMARRAY® – a well-recognized technology used in infectious disease diagnostics for rapid at-line detection of Mycoplasmas in the pharmaceutical industry.

They say “A rising tide lifts all boats” and this is true for advances in automation as applied to various analytical test methods. Have you checked the state of automation capabilities recently? There have been amazing advances in terms of (a) high throughput, (b) error reduction, (c) test organization and (d) value / analyst effort.

The BIOFIRE® Mycoplasma solution utilizes the FILMARRAY® 2.0 Industry instrument and a closed pouch PCR test to detect the presence of >130 species of mycoplasma. The system provides sample to answer in ~1 hour with little technical training required. This provides options for bringing mycoplasma testing in-house, thus saving time and outsourcing costs.

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).

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.

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.

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 may contribute to reduce cost and time linked to investigations and corrective actions.

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.

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.

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.

Both pharmaceutical companies and regulators have the same goal — ensuring continuous supply of safe drugs and therapies. Global pharmaceutical companies depend upon robust global supply chains to fulfil their endotoxin testing requirements to ensure patient safety. rFC is a safe, sustainable endotoxin testing solution that could mitigate many of the adverse trends impacting global supply chain consistency.

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings. Given that Limulus Amoebocyte Lysate (LAL) is packaged in vials (2.6 or 5.2mL) and reconstituted as needed, there is inevitable waste compared to using recombinant Factor C (rFC).