EXPERT’Biome CDMO by Lallemand

With EXPERT’Biome, create the Next Generation of Probiotics and Live Biotherapeutics

ExpertBiome cdmo lallemand health solutions

Leverage all assets of a vertically integrated trustworthy and agile partner, to support you as a CDMO in creating the next generation of probiotics and Live Biotherapeutic Products (LBP). EXPERT’Biome relies on 3 main pillars:

A robust research and development expertise in next-generation probiotics,
State-of-the-art facilities inspected accordingly to medicinal product GMP guidelines,
A reliable and experienced team in regulations applicable to probiotic and Live Biotherapeutic Product across the world and in compliance with food and pharmaceutical standards.

Innovative Scientific Approaches to Further Develop Next-Generation Strains

EXPERT’Biome leverages over 90 years of research and development expertise from Lallemand Health Solutions, specializing in fermentation processes for both traditional and next-generation strains. We support the development of your probiotic or Live Biotherapeutic Product (LBP) with a comprehensive, end-to-end approach. Our experienced CDMO team guides you through every stage, from the discovery phase to industrial-scale production, ensuring a robust and scalable process for your proprietary strains.

STRAIN

Lab Scale

Working cell banks establishment and verification
Strain characterization (genomic, metabolomic, nutrient requirements, etc)

DEVELOPMENT

Lab Scale

Culture media optimization
Process optimization (upstream and downstream)
Analytical method development

PROCESS SCALE-UP

Pilot Scale

Upstream and downstream scale-up
Stability studies on active principle

FINISHED PRODUCT

Pilot Scale

Formulation and galenic development
Primary packaging assays
Stability studies on finished product

Our team of over 40 R&D experts is strategically distributed across two Centers of Excellence: one in France, focused on bioprocess and galenic formulation, and another in Canada, dedicated to clinical research. This global structure ensures the successful execution of your development projects.

"EXPERT’Biome and Lallemand Health Solutions (LHS) continue to strengthen their presence in internationally recognized organizations, staying at the forefront of microbiome science and evolving regulatory landscapes :

Ferments du futur,
Le French Gut,
European microbiome innovation for Health,
Human microbiome action,
Pharmabiotic research institute,

This commitment enables us to meet the demands of cutting-edge projects in both health supplements and Live Biotherapeutic Products (LBPs).

Key figures:

A team of more than 40 R&D people
More than 430 publications
More than 180 clinical trials (25+ ongoing)
80+ in vivo
100+ in vitro
1 bioprocess and galenic expertise center
1 pre-clinical and clinical research center

Internationally Recognized Accreditations and Licenses Aiming for Excellence and Customers’ Trust

For industrial-scale development of probiotics and Live Biotherapeutic Products (LBPs), EXPERT’Biome benefits from CDMO manufacturing facilities located within the Lallemand Health Solutions (LHS) plants. These facilities hold GMP certificates by regulatory authorities and internationally recognized organisations of certification, ensuring full compliance with the stringent requirements of both the probiotic and LBP markets.

Our production sites provide comprehensive support for the industrialization of your probiotic and live biotherapeutic innovations.

Three accredited and certified bacteria plants (Canada and France), including Pharma GMP certifications:

Health Canada (NNHP, Non-prescription and Natural Health Products)
cGMP/US FDA cGMP (21CFR111,117– Dietary supplements)
UL, NSF, GRMA
C-TPAT
CFIA (Canadian Food Inspection Agency)
ISO 9001 / ISO 22000 & HACCP (France)
ISO 14001
TGA Clearance (Australie)
Religious status for certain strains (e.g. Halal, Kosher)

Certifications for drug manufacturing:

Health Canada – Good Manufacturing Practices for drug products – pharmaceutical (Part C, Division 2 of the Food and Drug Regulations)
ANSM – EU GMP for human medicinal products and human investigational medicinal products (EU GMP Part I)
ANSM – EU GMP for human medicinal products for active substances used as starting materials (EU GMP Part II)

TRANSFERT

Plant Scale

Specifications adjustments according to R&D phase results
Transfer from R&D to Operations, supported by Operational Excellence team

PRODUCTION

Plant Scale

From fermentation to formulation and packaging (sticks, sachets, capsules, tablets, boxes, bottles, blisters…)
Clinical and commercial batches (480 to 20,000 liters)
Validation batches
In process controls (IPC)

RELEASE

Plant Scale

Quality controls at each production steps
Availability and shipment of the product

Key figures (French pharma plant):

More than 130 employees
More than 75 years of know-how
Producing more than 80 million sachets per year
20M€+ continuous investments in the last 7 years

An Experienced Regulatory and Compliance Team Who Understands the Particularities of Each status and each Territory

At the forefront of global regulatory developments, EXPERT’Biome maintains direct communication with health authorities worldwide—including Health Canada, the U.S. FDA, the European Food Safety Authority (EFSA), Australia’s TGA, and Brazil’s ANVISA, among others. Backed by a regulatory and compliance team, EXPERT’Biome demonstrates strong leadership and is recognized as a trusted reference in the probiotic and live biotherapeutic industry.

EXPERT’Biome supports you all along your development projects and new products market approvals on all regulatory and quality aspects, necessary to their success.

STRATEGY

Regulatory

Strategy support
Ingredients and formulas compliance
Health authorities interactions

CLINICAL TRIALS

Regulatory

Clinical trial design review
Alignement according to targeted regulations

DOCUMENTATION

Regulatory

Dossiers
Master files

Allowing us an adequate and holistic regulatory strategy, our regulatory team is present in numerous worldwide organizations as:

Industry experts involved in the development of regulations

Panelist in numerous regulatory, trade and scientific conferences

Key figures:

More than 20 drugs/API registrations.
More than 40 approved health claims in Canada and 3 in Brazil
More than 200 food supplements registrations and support for compliant marketing worldwide

Lallemand Health Solutions EXPERTBiome CDMO by Lallemand

EXPERT’Biome CDMO by Lallemand

With EXPERT’Biome, create the Next Generation of Probiotics and Live Biotherapeutics

Innovative Scientific Approaches to Further Develop Next-Generation Strains

Key figures:

Internationally Recognized Accreditations and Licenses Aiming for Excellence and Customers’ Trust

Three accredited and certified bacteria plants (Canada and France), including Pharma GMP certifications:

Key figures (French pharma plant):

An Experienced Regulatory and Compliance Team Who Understands the Particularities of Each status and each Territory

Allowing us an adequate and holistic regulatory strategy, our regulatory team is present in numerous worldwide organizations as:

Key figures:

Links

EXPERT’Biome, CDMO by Lallemand, to accelerate development & production of next-generation strains.

Lallemand Health Solutions - Probiotic Manufacturing Process - St Simon Plan

Lallemand Health Solutions EXPERTBiome CDMO by Lallemand

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