Our state-of-the-art clinic sites both in Ireland and the USA ensure we can offer multicentre multinational studies of all design types, across a broad and diverse array of health areas and product portfolios. Our highly qualified and dedicated team will help you manage all aspects of your clinical project and guide you through the entire process, while keeping you fully informed of progress. As we own and operate our own clinics all of our ICH-GCP certified team are on hand to ensure your data is of the very highest quality and integrity and in strict accordance with the protocol.

Some of our extensive clinical areas are healthy ageing, gastrointestinal function and disorder, physical activity and sports performance, nutritional investigations, stress and cognitive health and decline , cardiovascular health, metabolic syndrome, bone and joint health, immune function and microbiome dysbiosis of the gut, skin, vagina and oral cavity.

Many of the studies we work on have been and are investigations of microbiome therapeutics and other active ingredients in both healthy and patient populations. These include LBT’s, prebiotic fibres, probiotics strains and a host of other products.

Next-generation sequencing (NGS) technologies have been crucial in investigating and characterizing the human microbiome. However, the transformation of NGS data into actionable solutions is limited by challenges related to precision, turnaround time, cost per sample, and the need for complex bioinformatic pipelines. For this purpose, Bio-Me developed Precision Microbiome Profiling (PMP™) in collaboration with Thermo Fisher Scientific. PMP™ is a novel qPCR-based platform that allows accurate, quick (100-200 samples in 2 hours), reproducible, and cost-efficient large-scale microbiome profiling at the species/strain level. The output consists of quantitative and ready-to-use results, overcoming the need for bioinformatics data processing.

Bio-Me’s proprietary pipeline allows the development of specific qPCR assays for the microbial targets of interest. We currently offer four off-the-shelf profiling solutions:

1. Gut Microbiome Extensive Panel
2. IBD/IBS/Gut Health Screening Microbiome Panel
3. Colorectal Cancer Microbiome Panel
4. Vaginal Microbiome Panel

In addition, we offer a convenient gut microbiome sampling solution as a kit and extraction/purification of DNA.

Moreover, we are developing a dedicated skin microbiome panel covering major organisms important for skin health. We are also working on an immuno-oncology and an infant gut health panel. Thanks to the flexibility of the PMP™ platform, we can customize microbiome profiling panels according to our clients’ needs.

Bio-Me works with leading academic institutions worldwide and key opinion leaders in the microbiome field. We support pharma and biotech companies during the clinical development of microbiome-modifying drugs with our profiling solutions and our access to fecal samples and anonymized medical registries from more than 13 000 subjects (collaboration with HUNT4). In addition, Bio-Me participates in clinical trials for several disease areas, such as cancer immunotherapy, IBD, and colorectal cancer.

Key Features of PMP™

• End-to-end solution – From sample collection kit to microbiome profile results
• Short turnaround time – Results ready in 2-5 hours from sample arrival
• High throughput – Hundreds of samples analyzed simultaneously
• Ready-to-use results – No bioinformatics steps needed from your side for data processing
• Absolute quantification – The output is the number of genomes per ng of DNA
• High-level resolution – Species, subspecies, and strain level
• Highly reproducible and accurate

Products and offerings

Off-the-Shelf Offerings

Custom Solutions

Under Development

Founded in 1978 as a biochemical research center, the company focuses its main activity on the study of the dairy sector and in the development, production, and marketing of Lactic Acid Bacteria (LAB). During its 44 years of activity, Biochem SRL has made use of innovative production technologies for the development of its products, specialized technicians, and a great passion for the agro-industrial microbiology.

Vision

Quality, customization and rapidity in development are the fundamental keys to satisfy the customer’s needs and preserve tradition. This is the philosophy that the company applies every day in its products and in relations with national and international customers, pleased to be able to forge a solid partnership with our customers. Thanks to the experience and passion of highly specialized technicians, our laboratories can create “tailor-made” cultures of lactic bacteria according to customer needs, offering careful technical advice in the use of products in full respect of tradition.

Development areas

• 1978: the company has focused its attention on the dairy sector, both with the production of LAB dedicated to the dairy industry, with laboratory analyzes aimed at technical support of customers and the achievement of R&D objectives. The dairy sector currently represents the principal Business Unit.
• 2014: the company has isolated, reproduced, and industrially tested selected cultures for the meat sector, a sector currently in strong growth.
• 2016: the company has undertaken the development of special probiotic cultures aimed at applications in the livestock and human sectors.

R&D area

The active collaboration with our customers and the rapidity in the development of projects allow us to always be at the forefront of the sector, anticipating the market demands. The knowledge acquired over time in the agri-food industry and the continuous technological investments allow us to operate and develop new solutions aligned with the market trends.
The principal activities carried out by our R&D department are:

• Isolation, selection, and genetic characterization of strains.
• Optimization of the development conditions of the strains.
• Production in liquid, frozen, freeze-dried format for volumes ranging from 1.5 to 5,000 liters.
• Optimization of bacterial growth conditions and strain concentration.
• Optimization of the lyophilization conditions of the strains focused to obtain their maximum survival and stability over time.

Company certifications

Since the early years, Biochem SRL has always put the quality of its products first.
During its 40 years of work, it has obtained various quality certifications:

• 1998: ISO 9001
• 2008: Product certification from Bureau Veritas Italia.
• 2016: Halal certification of its products certified by Halal International Authority (HIA) and Kosher.
• 2016: Certification of products in accordance with the BRC and IFS regulations certified by Bureau Veritas Italia.

Probiotic sectors

The production activity of Biochem SRL in the probiotic areas for Nutra & Pharma applications could develops in two ways:

• Third party production of bacterial strains owned by the pharma industries.
• Production of own probiotic strains commercialized with LACTOFERM brand.

Biofarma Group is the new Italian and European market leader in developing, producing, and packaging food supplements, medical devices, probiotic-based drugs, and cosmetics exclusively for third parties. With a turnover of around 300 million euros expected in 2022 and 914 employees, Biofarma Group is already a focal point in the Health-Care sector in the Italian and European markets. 

The Group is the result of the merger between Biofarma and Nutrilinea, two Italian excellences in the development and production of Health-Care products, involving, in addition to the previously mentioned ones, three other reference companies in the sector: Apharm, Claire, and Pharcoterm. Furthermore, at the end of 2021, Biofarma Group acquired Giellepi’s Finished Products division, which led to the creation of International Health Science (IHS), strengthening the Group’s presence on the market with “ready to market” products complete with clinical trials.

The latest acquisition in 2022 is the takeover of Nutraskills, a fast-growing French company specialising in the development, production and packaging of dietary supplements for third parties.

Through a process of aggregation that respects and enhances the professionalism and skills of the collaborators, the Group aims to create a solid corporate structure. Looking to the future with continuity and with a great inclination to accelerate the processes of innovation, change, and continuous improvement to establish itself on the international market and be competitive at a global level in the world of Health Care products. This growth objective is based on the intentions of three main change agents: entrepreneurs with their vision, management with their strategic and organizational capacity, and the finance world with the tools and relationships to support the company. 

Innovation, production excellence, and the high professionalism of the team are the values at the base of this new industrial project. The skills that make up each company of the Group. Six production sites distributed between Italy and France, allow us to offer customized solutions and an even more complete and transversal service ranging from the development of the idea to the finished product, as well as a vast catalogue of products, including dossiers, some of which are patented, available in out-licensing for customers with the possibility of being marketed all over the world.

Investments in innovative projects, production processes, and cutting-edge machinery, as well as in human capital, will allow the Group to become a beautiful and competitive reality, able to generate a sustainable and lasting impact on the territory, to look to the future and to establish itself on the market as a European leader in the development and manufacture of Health Care and Beauty Care products.

Biofarma Group in numbers

• Around 300 million euros in sales (expected value 2022)
• 914 Employees
• 6 production sites in Italy
• 88 state-of-the-art technologies (patented or in the process of registration)
• 100 thousand square meters, of which 61 thousand square meters dedicated to logistics and production
• 170 production and packaging lines for food supplements, medical devices, and cosmetics

Production sites

• Mereto di Tomba (UD) and Headquarters
• Gallarate (MI) – Italy
• Cusano Milanino (MI) – Italy
• S. Pietro Viminario (PD) – Italy
• Herbergement, Pays de la Loire – France
• Sérent, Brittany – France

Aerobic colony count
Yeast and mold count
Enrichment method for specific pathogen screening
Total gram negative test

CosmosID also offers independently validated, industry-leading pipelines for processing metagenomic data, yielding multi-kingdom, strain-level resolution with leading sensitivity and precision. Results can be accessed via CosmosID-HUB, a user-friendly and interactive software for comparative analysis of microbiome data, complete with dynamic charts, visualizations, and statistics.

With a legacy of scientific rigor and sustainability, dsm-firmenich continues to redefine ingredient excellence and clinical relevance in the nutraceutical and functional food sectors.

For nearly 25 years we are working hand in hand with the world’s leading probiotic manufacturers to offer premium shelf-stable strains validated by gold standard clinical trials. Thanks to our extensive know-how in handling live bacteria, yeast and spore-forming bacteria, we have supported major global brand owners to develop successfully a variety of innovative probiotic-based formulas in different delivery formats.

Today, as developer and supplier of unique ingredients based on extensive clinical support, sustainable sourcing methods and strict quality control, our commitment to our customers runs deep from delivering R&D formulation expertise and regulatory compliance to providing the best customer service and technical support.

Innovation

In an increasingly competitive and global market, Giellepi has a strategic vision that is innovation-oriented; we research and study proprietary ingredients with unique technical and technological characteristics that are key in formulating cutting-edge finished products.

Research

The research activity of Giellepi is aimed at the characterization of the active compounds present in the raw materials, their metabolic function, bioavailability and safety. Our ingredients are carefully selected on the basis of precise quality requirements that allow us to be distinctive in the nutraceutical market.

Partnership

Our extensive network of suppliers comprises the best-in class producers of health ingredients from Europe, China, India, Japan, Australia, New Zealand, Israel and United States of America.

Our market-ready, science-based branded solutions include:

µsmin® Plus, a bio-enhanced form of diosmin for leg health and beauty.

Axtragyl®, a botanical extract for greater mobility.

Kalita™, a bergamot extract for metabolic wellness.

Poolzyme™, a line of enzyme formulations studied to meet individual digestive needs.

RossoPuro® Forte, a proprietary blend of natural components derived from fermented rice and plant for the management of healthy cholesterol levels.

For the Italian customers our product range includes a large variety of clinically studied probiotic, yeast and spore forming strains for digestive health, immune health, women’s health, brain health, children and infant health, oral health and weight management.

Morinaga Milk holds a leading marketing position with its many top brands in yogurt, milk, infant formula, beverage, cheese, butter, ice cream, pudding, dietary supplements and clinical foods. The functional ingredients manufactured and supplied globally by Morinaga Milk include HRB probiotics, postbiotics LAC-Shield, lactoferrin, lactulose, whey proteins, and peptides, among which are used in high value-added nutritional products such as infant formulas, dietary supplements and functional foods.

Morinaga Milk started research of Human-Residential Bifidobacteria (HRB) in the 1960s, inspired by the fact that bifidobacteria are the predominant bacteria residing in the intestines of breast-fed infants. Below are the main strains of Morinaga Milk’s HRB probiotics.

BB536: well-documented multifunctional probiotics

Bifidobacterium longum BB536, the flagship probiotics of Morinaga Milk, is one of the most well-established, clinically effective probiotic strain that confers numerous profound beneficial effects on humans. BB536 possesses a proven track record of safety and clinical efficacy in improvement of intestinal health, maintenance of intestinal microflora balance, regulation of immune response, anti-allergy, and protection against microbial infections, as demonstrated in more than 220 scientific studies (as of March 2022).

Regulatory status of BB536:

1996 Japan FOSHU status
2009 FDA notified GRAS status for foods
2019 FDA notified GRAS status for infants
2022 China New Food Ingredient for use in infant and toddler foods

M-16V: ideal probiotics for infant health

Bifidobacterium breve M-16V is one of the best studied clinically effective probiotic strains that exert positive effects, particularly in infants, to support healthy growth and promote well-being. Its safety and effect to promote healthy growth of premature infants are highly evaluated by medical professionals. To date, M-16V is used in more than 150 Neonatal Intensive Care Units (NICUs) in affiliated hospitals in Japan, Australia, New Zealand, and Singapore.

Regulatory status of M-16V:

2013 FDA notified GRAS status for foods
2013 FDA notified GRAS status for infants
2016 China authorized probiotic strains for infant’s food

M-63: probiotic for infant use and beneficial for healthy mood

Bifidobacterium infantis M-63 is unique among gut bacteria in its immense capacity to utilize human milk oligosaccharide (HMOs), the component that is highly abundant in human breast milk. HMOs offer no direct nutritive value for infants, but they function in shaping a better infant gut microbiota with life-long impacts. M-63 possesses superior potential to colonize and adapt to the intestinal environment of humans, especially infants. In addition, M-63 also shows potential in improving mental state in individuals with irritable bowel syndrome (IBS).

B-3: a unique probiotic for weight management

Bifidobacterium breve B-3 is a unique probiotic strain developed by focusing on the relationship between gut microbiota and metabolic syndrome. B-3 possesses an attractive effect in maintaining healthy body weight and ultimately improving one’s lifestyle.

We improve human health through beneficial microbiome bacteria, the effectiveness of which is: Proven by science. Naturally.

Nordic Biotic brings clinically proven probiotic products at an affordable price to a market where most products have limited scientific evidence.

Today, we are 10,000 people worldwide whose expertise spans more than 30 different industries. All around the world our biosolutions already create value for thousands of customers and benefit the planet. Our solutions enable feeding and fueling the world more sustainably, from healthy and sustainable nutrition to biofuel. Biosolutions also reduce the use of fossil-based resources, chemicals, energy and water. And this is just the beginning. The potential is almost endless.

The time for biosolutions is now. And by working closely with our partners and customers, we will continue to challenge conventional thinking and transform business with biology. Together, we will create the change our world needs.

Let’s better our world with biology.

PharmExtracta^® was born from the experience of professionals in the pharmaceutical and nutraceutical sector who share a great passion for scientific innovation and aim at finding new solutions for human health, in line with most recent discoveries. 

From the beginning of the project our R&D team developed and marketed more than 70 formulations, backed up by more than 40 patents, and published more than 200 peer-reviewed scientific studies confirming the scientific rationales behind products.

Starting from 2010s PharmExtracta^® is particularly focused on launching new effective probiotics under the range called PrecisionBacterial Care.

In 2011 we were the first company in Europe to develop and launch Bactoblis^®, a finished product containing the well-known Streptococcus salivarius K12, the first probiotic for the oral cavity that now boasts numerous studies all over the world.

Bactoblis^® was then awarded at the Nutraingredients Awards as Finished Product of the Year in the category “Immune Support” in 2015.

More recently, in 2021, our probiotic formulation Crispact^®, containing Lactobacillus crispatus M247 for women’s health, was selected asfinalist in CPhI Pharma Awards in the category “Excellence in Pharma: Finished Formulation”.

Our cornerstones of probiotics

When it comes to probiotics, PharmExtracta^® chooses only well-characterized strains deposited in strain collections recognised as “International Depositary Authority” (IDA).

Before becoming PharmExtracta^®’s products strains must prove

• to be 100% safe for human consumption
• not to confer antibiotic resistance
• to survive stomach and bile acids
• to adhere to epithelial cells of the target area

Moreover, our finished products are designed to maintain bacterial strains live and viable using

• high-dose probiotic contents
• specific packaging solutions
• proper storage conditions

We strongly believe in precision probiotics able to provide specific health benefits. In this view, we launched several single-strain formulations that can be effectively used in the clinical practice.

The greatest strength of our products is their effectiveness that is validated clinical trials.

Why you should choose PharmExtracta^®’s probiotics for your portfolio

There are many reasons why you should cooperate with PharmExtracta^®.

First and most important of all, our products are simply unique, formulated out of scientific research and designed to work. The health benefits of our products speak for themselves.

Secondly, PharmExtracta^® may help partners distinguish themselves from competitors, not only by providing new groundbreaking products, but also by sharing kwowledge and best practices for communicating the strengths of products to healthcare professionals and target audiences.

Products in the spotlight

Bactocillin^® containing the probiotic strain Bifidobacterium breve PRL2020, the only probiotic product with intrinsic, non-transferable resistance to amoxicillin and amoxicillin/clavulate. The ideal add-on treatment to these drugs to avoid dysbiosis and antibiotic-associated side effects.

Crispact^® containing the probiotic strain Lactobacillus crispatus M247. L. is the A-lister for vaginal microbiota and overall women’s health. The special strain M247 possesses intrinsic, non-transferable resistance to metronidazole and can survive high concentrations of boric acid, being therefore the best candidate to replenish vaginal environment also while taking these medications.

Gabapral^® new psychobiotic product containing Bifidobacterium adolescentis PRL2019, bacteria strain with high GABA producing capacity capable to affect the gut-brain axis, alleviating anxiety, mood alterations and generally counteracting gut dysbiosis and related symptoms.

Thanks to our patented PBTech® technology, we are able to carry out the natural fermentation of bacteria and produce postbiotics from different strains, ready for different uses.

Since our founding in Sweden in 1991, Probi® has expanded its presence to more than 40 markets globally. We combine innovative R&D, a keen knowledge of the latest trends, and state-of-the-art research to develop clinically proven probiotic solutions that add a unique competitive edge to our customers’ products.

High-quality and clinically documented probiotics to make your brand stand out

Our probiotic health concepts, formulations, and formats are supported by robust clinical documentation. We have an extensive probiotics portfolio (Probi ClinBac™) within broad health areas, including digestive and immune health, as well as unique health positions such as iron-absorption and bone health. We also offer solutions that target specific consumer groups, including children, women, and seniors.

To date, our scientists and research groups around the globe have published more than 300 peer-reviewed scientific articles and more than 70 clinical trials for the strain LP299V® alone. We also hold more than 400 granted patents and patent applications.

With €900m net commitments under management as of the end of 2021, Seventure is a leading venture capital firm in Europe investing since 1997 in innovative businesses with high growth potential in 2 main fields: Life sciences (Health & digital Health, Foodtech, Blue Economy, Animal & Agriculture, Sport & Wellness …) across Europe, Israel, Asia and North America and Digital technologies (FinTech, RetailTech etc…) in Europe.

Investments can range between €500k and €10m per round, or up to €20m per company, from early to late stage, growth, pre-IPO and IPO.

Sport & Performance capital, launched in 2019 is an institutional fund supporting companies in Sport and wellness