OptiBiotix: Screening, Optimisation and production of probiotics: from lab to clinical trial

At NIZO we do research that is important for our clients’ business needs: quality and speed.

OptiBiotix Health plc (AIM: OPTI), a Life Sciences business developing compounds to tackle obesity, high cholesterol and diabetes, approached NIZO approached NIZO to optimise the manufacturability of its proprietary strain LP-LDL™ which has probiotic properties to help prevent and manage a number of health conditions such as high cholesterol, high blood pressure, glucose and energy regulation, vitamin metabolism, and liver function. LP-LDL™ is now commercially available via several license deals throughout the world closed by OptiBiotix in 2017 (www.optibiotix.com).

NIZO Probiotic Optimisation Pipeline

OptiBiotix contracted NIZO to assess on a selection of OptiBiotix’ strains its genome sequence, manufacturability and gastrointestinal robustness which ultimately led to the selection of LP-LDL™ .The product is now being produced by Sacco in Italy for the world market.

NIZO’s Probiotic Optimisation Pipeline is deployed for optimal production of probiotics: Finding optimal upstream and downstream processing conditions for both traditional probiotic strains as well as strict anaerobic species such as gut-derived bacteria and skin-derived bacteria. It focuses on:

  • Screening of optimal growth conditions: strains and media
  • Screening of optimal freeze dry conditions: harvest moments and choice of cryoprotectants
  • Shelf life stability optimisation of optimal combinations of 1) and 2).

A sequential optimization of these properties is in general unable to identify the optimal process. This is due to the influence of both, the media and the harvesting moment on the optimal cryopreservative formulation for final shelf life stability. For this reason the only way to identify the optimal ingredients for a probiotic product with a maximal shelf life, is to test all possible combinations of medium, harvesting moment and cryopreservative formulation. Naturally this means that one ends up with thousands of different combinations that require testing. Using the standard technologies for CFU analysis, such research would be cost prohibitive due to the large amount of human resources required. For this reason NIZO has developed the Probiotic Optimisation Pipeline to screen for the optimal combination of growth medium, harvesting moment and cryopreservative formulation, allowing to optimize fermentation yield and shelf-life stability.

The system uses a range of bioreactors in which different potential probiotic strains can be grown in different media. During the course of the experiments, samples are taken continuously, mixed with a large range of cryopreservative formulations which are then subsequently frozen and freeze-dried. Using a specific high throughput CFU analysis system allows us to determine the viability of the probiotics during shelf life in the application of choice.

Production of probiotics: batches for clinical trials

NIZO produced early pilot batches of LP-LDL™ used in clinical trial on 50 hypercholesterolemic subjects in which the strain proved to be completely safe and well-tolerated and resulted in a lower total cholesterol by up to 36.7%.

NIZO typically produces batches of probiotic and strict anaerobic bacteria (non-GMP) for clinical trials in its foodgrade Processing Center. The production of probiotics is executed according the client’s needs and we offer flexible production processes and different product matrices for the bacterial strain of choice.

Stephen O’Hara, CEO of OptiBiotix, commented: “Pilot batch production of our probiotic for our first human study was carried out by NIZO who also introduced OptiBiotix to potential contract manufacturers of freeze-dried probiotics and packagers. All this work was carried out to  strict timelines to allow us to achieve our commercial milestones.  I would recommend NIZO as a reliable contract research group.”

Can we help you in discovery, upscaling and commercialisation in the field of probiotics?

About OptiBiotix Health Plc

OptiBiotix Health Plc is a life sciences company operating in one of the most progressive areas of biotechnological research – the modulation of the human microbiome (www.optibiotix.com). Probiotics Market size was above USD 35 billion in 2016 and is expected to witness more than 7.4% CAGR to 2024.

Probiotics are microbes or microorganisms which when consumed in suitable quantity affect consumer health beneficially. It is majorly used in dietary supplements, dairy products and other food & beverage products and animal health products. Species like Lactobacillus and Bifidobacterium are commonly used ingredients. Drugs containing these microorganisms are tested according to standards set forth by Food & Drugs Administration and are labelled as Live Biotherapeutic Products (LBP).

Would you like to know more about production of probiotics? Contact: Nils Hijlkema, Business Development Manager Skin Care, Live Biotherapeutics and Probiotics market.

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