A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics

16th September 2020 | 10:30 am PST, 13:30 pm EST | Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MAT |WATCH FOR FREE

Large-scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases, or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic, or inflammatory responses in humans or product degradation or modification. The Case-by-Case Assessment of Bioburden (CCAB) approach described here enables a comprehensive assessment of these risks.

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche

Friedrich is QC Lead of the iNeST Project (individualized Neoantigen Specific Therapy) at Roche-Genentech.

After studying biology with a focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany.

He joined Roche in 2001 working as a Micro lab Manager and Senior Manager on various topics (environmental monitoring, cleaning analytics, microbiological IPC and analytics for release, endotoxin testing, LER).

Friedrich led several Roche-Genentech expert teams (e.g. identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery /LER) and co-chaired the PDA Low Endotoxin Recovery Task Force. He also chaired and co-chaired several Endotoxins and Pyrogen Sessions at Pharmalab and PDA and is a member of the new PDA ATMP advisory board.

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As the biological complexity of drugs increases, so too does the complexity of production processes necessary to deliver them, as well as the risks of microbial contamination from multitudinous, often unaccounted sources.

Using microbiological testing as risk assessment to assure the drug is free of microbial contamination is no longer deemed sufficient by the European Pharmacopeia. These methods are now known to be unable to detect microbial components that significantly compromise product quality and potentially in turn, patient safety. Instead, the EP emphasises the use of pyrogen testing.

At the same time, however, EP regulations (2.6.8) have started to crack down on a shift away from the Rabbit Pyrogen Test towards the use of non-animal-based pyrogenicity assays. Though the EP specifically recommends the use of the in vitro Monocyte Activation Test (MAT), the lack of any market ready and affordable commercial MAT offering has meant that producers of medicinal products have increasingly started to employ the in vitro Bacterial Endotoxin Tests (BET) like the LAL or rFC.

Though these tests are indeed sensitive, affordable and quick, they fail to detect the full spectrum of endotoxin and non-endotoxin pyrogens which may contaminate complex biological products. Not only is the sole use of these endotoxin tests a break of EP regulation, it puts patient safety at risk.

Shabnam Solati will detail the introduction of a new type of Monocyte Activation Test that has been made available on the market. An affordable kit based on cryopreserved 4 donor pooled PBMC, this MAT kit delivers the most sensitivity of any pyrogenicity assay available on the market (0.004 EU/ml), consistently reproducible results and batch sizes of up to 2000 kits which allow it to facilitate mass demands of the market.

Presented by Shabnam Solati, CEO & Co-Founder at CTL-MAT

Shabnam Solati, CEO & Co-Founder, developed a Monocyte Activation Test to meet the end-to-end MAT needs of the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to building the future of MAT beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

Sponsored by CTL-MAT – The MAT Company

CTL-MAT – The MAT Company was established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test – measuring endotoxins and non-endotoxin pyrogens alike. CTL-MAT’s products and services permit Ph. Eur. 2.6.30-compliant, robust and accurate detection of pyrogenic contaminants in parenteral drugs, biopharmaceuticals, cosmetics, solid medical devices and other medical products. For More information visit https://www.ctlmat.com


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