Microbiome Solutions

• Co-creation from stakeholders and community input: Stop the guesswork !. Our prototype concepts come from science/evidence-based research conducted by our researchers, sensory research from panellists, competitors and product market research, and inputs from consumers through focus groups, interviews, regional-focused consumer journey mapping, and many more. Get information that allows you to make crystal clear decisions.
• Ingredient Focus: We build our prototype with the use of real, clean, fresh and authentic ingredients (such as free from an allergen, no pesticide/chemicals/toxins, non-GMO, organic, vegetarian, gluten-free, and minimally processed) without compromising on sensory appeal.
• Clean Label: No complex labelling disgusting ingredients in the formulation. We offer clean labelling with maximum transparency around any health claims by replacing fewer desirable ingredients with label-friendly ingredients.
• Sensory and Shelf Life: Our prototype meets your sensory within the sphere of physical and scientific possibility by using a unique combination of ingredients without negatively affecting their colour, taste, texture and shelf life.
• Regulatory: A prototype that meets the regulatory requirement that governs food processing, including those established by the local and international regulations (e.g., FDA and EU regulations )
• Science-Based Nutrition: An evidence-based prototype that specifically meets the targeted consumer base's nutritional requirements as per the recommended dietary allowances. This includes reduced sugar content (e.g., use of Stevia and erythritol) and low calories with added functional benefits.
• Health Claim: Functional and Health claims as per the regulatory norms (e.g., no added artificial colours or flavours, and low in sugar)

Prebiotics, probiotics, and postbiotics and combinations of these terms commonly describe microbiome products (Symbiotics). These are not, however, product categories that are regulated. The functional status may change depending on the product's intended purpose (e.g. target indication and population claims), composition, route of administration, and mode of action. Examples are drugs, Live Biotherapeutic Goods (LBPs), biological medicinal products, functional foods, food/dietary supplements, medical devices, transplants, and tissues and cells. Some are only applicable to microbiome products (e.g., Faecal Microbiota Transplant (FMT)), while others apply to health goods.

FRL Healthcare assists in developing products in a wide variety of regulatory statuses, including pharmaceuticals (biologics, ATMP), medical devices, FSMPs, and food supplements. We have extensive experience in infectious illnesses, inflammatory diseases, immunology (including allergies), metabolic disorders, and cancer, with frequent applications in the gastrointestinal system, skin, and the gut-brain axis.

Given the variety and complexity of the human microbiome, selecting and developing a nonclinical study model for microbiome research remains a problem. The fundamental question is "What do we need to show using a nonclinical model?" rather than "Are there any nonclinical models?" Many nonclinical models have been produced, including an in vitro human gut microbial community simulator and germ-free or gnotobiotic models (i.e., inoculated with defined microbiota animal models).

At FRL, we develop products that address communicable and non-communicable or chronic or systemic diseases, including diabetes, immunity, obesity, heart disease, cancer, cardiovascular, kidney disease and many more. For instance, we develop supplements, powders, and drinks.

The role of probiotics in preventing upper respiratory infections has been studied extensively. At food research lab, we formulate probiotic supplements based on the specific requirement of the clients. We can incorporate probiotics into the diet in the form of yoghurt (e.g., with lactobacillus delbrukckiis sp. Bulgaricus, Lactiplantibacillus Plantarum or Lactiplantibacillus reuteri ), bread, sourdough, tempeh, bread, kombucha, cottage, cheese, fermented sauerkraut, fermented pickle, miso soup, and kimchi.

Functional dairy-based beverages enriched in probiotics are an optimum way to reestablish the intestinal microflora balance. Our formulation experts ensure that the probiotics (e.g., Lactobacillus acidophilus (L. acidophilus) and Bifidobacterium animalis subsp. Lactis) comply with neutral pH, total solids level, absence of oxygen, and near ambient temperatures. Probiotic drinking yoghurt with L Casei Imunitass cultures, B Longum BB536, S Thermophilus, L delbrueckii subsp bulgaricus, milk drink containing Lactobacillus Casei Shirota Drink yoghurt with LGG, vitamins and minerals. Our food experts ensure the stability of these formulations and ensure the protection of functional ingredients within edible delivery methods.

Our formulation scientists develop fermented milk products by incorporating living micro-organisms (e.g. Lactobacillus rhamnosus GG, Lactobacillus reuteri, bifidobacteria and certain strains of Lactobacillus casei, the Lactobacillus acidophilus-group, Escherichia coli strain Nissle 1917, certain enterococci, especially Enterococcus faecium SF68, and the probiotic yeast Saccharomyces boulardii), high health benefits as in Lactobacillus Plantarum isolates (PCS20, PCS22, PCS25 and PCS26) from Slovenian cheese with high antimicrobial and immunomodulatory capabilities

Today, only bifidogenic, non-digestible oligosaccharides (particularly inulin, its hydrolysis product oligofructose, and (trans)galactooligosaccharides), fulfil all the criteria for prebiotic classification. Our expertise can develop infant formula more breast-milk-like by the addition of fructo- and (primarily) galactooligosaccharides—fructooligosaccharides (FOS) with prebiotics resistant starch and β-glucan, carbohydrate components of whole grains.

We formulate yoghurt, sauerkraut, garlic, gummies, immune gummies, supplements, probiotics tea, mushroom-infused wellness shots, fruit snacks, oat beverages, drinks, dairy-free yoghurt, and cheese with probiotics in the form of live lactic acid bacteria. We use strains such as Lactiplantibacillus Plantarum HEAL9, Lacticaseibacillus paracasei 8700:2, Bifidobacterium breve MCC-1274, the proprietary strain of Moringa Milk and many more. Our procurement team from FRL hunt for the latest innovations to identify best practices globally to develop postbiotic products.

We develop baked goods and confectionery products, probiotics Food & Beverages (Dairy Products, Cereals, breakfast cereals, Baked Food, Fermented Meat Products, Dry Food Probiotics & Others), probiotics dietary Supplements (Food Supplements, Nutritional Supplements, Specialty Nutrients), Infant Foods, Animal Feed probiotics using the latest technology and processing method at the same time maintaining shelf life and an appealing appearance, texture and taste. We adopt both para-probiotics and FIFs, where the latter is non-viable probiotics or inactivated probiotics, while the former is an infant or follow-on formula that has been fermented with lactic acid-producing or other bacteria and, in most cases, does not contain viable bacteria.

Having a well-designed program backed by flawless data is essential for maintaining control over your product’s quality from start to end. We perform quality assurance testing through our full-service laboratory, The Food Research Lab, to assist you in verifying that your formulation prototype’s consistent quality is an advantage to your business. Microbiology analysis, nutritional analysis, and diverse food chemistry analyses are some of the services we provide to our clients.

We deliver nutritional products for sensory and master data records of product, process and packaging information. This includes raw material specifications (type/subtype), metal testing, nutritional analysis, physical/chemical data, kosher/Halal information, GMO Status, microbiological status, supplier information, vendor ingredient line declarations, vendor warrants and guarantees, cost data, certificate analysis of requirement, regulatory data, test methods, allergen data, shipping and handling info, safety document (MSDS or SDS), proprietary info, sensory and quality information.

We have a list of vendors who can supply us with the product required for an R&D. All our vendors have been scrutinised based on the stringent quality criteria in terms of certificates they hold and the experience they have in the product line. We ensure 99% consistency in all the ingredients and will share the final list of ingredients and the vendor lists as part of our SOP. We consider more than one supplier of the same product to test quality and cost-effectiveness. If more than one supplier is used, tight product specifications will be followed. However, all ingredients will undergo basic testing before it moves to the product development phase.

Our sensory examination leads to the precise formulation and recipe recommendations. We develop data-driven design models based on sensory research and customer insights. The fact-based design methodology used by FRL reduces risk and gives our clients market confidence while cutting development time in half. With our dedicated sensory lab facility, our team takes satisfaction in creating and optimizing successful products in the marketplace, generating a favourable return on investment, and developing brand advocates

We have an in-house dedicated multidisciplinary team with expertise in food science, consumer and sensory science research, microbiology, ingredient development, biochemistry, culinary arts, regulatory, and manufacturing design. As such, we can deliver a high-calibre product with the expertise of emerging and cutting-edge technologies (e.g. technologies in food preservation - High Hydrostatic pressure methodology HHP, dielectric heating, pulsed light, bacteriocins; extractive emerging technologies: ultrasound-assisted extraction, ohmic heating, high pressure, supercritical fluid extraction and microwave-assisted extraction) and suitable facilities to conduct scientific and technical tests. Our experts are very facile around new food product development with vast categories of product lines.

FRL scientists and formulation experts develop a highly functional strength product that provides the intended results. We adhere to the international guidelines and formulate our product at the same time meet the dairy-free claim as well. Our formulation experts ensure that the end product would meet the required pH, dispersibility, efficacious dosage, shelf life, glycemic index, desired satiety, mouthfeel, flavour, odor and taste. Through years of expertise and knowledge, we bring in the right solutions that fit your requirements.

Any ingredient incorporated into the formulation needs to achieve its intended function in the human body at the same time, must adhere to safety guidelines. For instance, for the beneficial effects of probiotic microorganisms to be seen, it is recommended that the number of viable cells reaching the intestine should be at least 106–107 colony-forming units (CFU)/g . At FRL , we substantiate this from many different types of investigation, including secondary research for existing ingredients or, if its novel, publishing the work in reputable, peer-reviewed journals. Data for this will be derived from chemical comparisons and analysis, activities (e.g., ORAC or oxygen radical absorbance activities), testing in animal models, genomic/gene expression studies, in vitro bioassays and, most compelling of all, human clinical testing. Through years of expertise and knowledge, we bring in the right solutions that fit your requirements.

The viability of microorganisms varies depending on many conditions, such as the characteristics of the microorganism, the acidity degree of the product, the storage temperature, and the characteristics of the packaging materials used. We follow quality measures to ensure the products are safe from both the supplier and the buyer's perspectives. We carry out Marker Chemistry (e.g., HPLC, GC etc.), Microbiology tests (e.g., Pseudomonas, Salmonella, Escherichia Coli), heavy metal analysis (e.g., lead, arsenic, cadmium kept below the regulatory limits), Contamination (e.g., metal flakes from machinery), physical characteristics (e.g., powders for tablets must have low moisture content) and stability (e.g., the time for a product from initial production). We use compendium methods (USP and European Pharmacopeia) for an extensive validation process.

We follow a specific set of regulations that a product must adhere to. This includes manufacturing flow chart, solvents, quantitative ingredient lists, physical characteristics, GMO status, certifications, radiations, pesticide/chemical/ residue, contaminants, microbiology, allergens, animal derivation, and safety (Standard Material Safety Data Sheet – toxicity or clinical testing). We assist ensure to clear the ingredient supplier completes clearance through the target country’s regulatory agency prior to its inclusion in formulas. Through our years of experience, our team can speed up the acceptance and inclusion of new material. Our product development team complies with the Food, Drug and Cosmetics Act (FDA 2009), DSHEA and the Fair Packaging and Labeling Act (Federal Trade Commission 2011), safety and quality food and food supplements guidelines delineated by WHO and the United Nations Food and Agricultural Organization (FAO). Our team ensures to use only acceptable ingredients that are found in the International Nomenclature. We also adhere to the local country’s guidelines as per the client’s request, such as for the Japanese Ministry of Health, Labor and Welfare (MHLW), The Chinese Health Care Association (CHCA), China’s State Food and Drug Administration (SFDA) and FSSAI.