EXPERT’Biome CDMO by Lallemand - Lallemand Health Solutions

Create The Next Generation of Probiotics and Live Biotherapeutics

Leverage all assets of a vertically integrated trustworthy company, to support you in creating the next generation of probiotics and live biotherapeutics. We developed among the past years a robust research and development expertise in next-generation probiotics. We can leverage state of the art GMP Pharma facilities and we can rely on an experienced pharmaceutical regulatory and compliance team.

Innovative Scientific Approaches to Further Develop Next-Generation Strains

• Cell bank establishment and verification
• Strain characterization
• Process optimization at lab scale
• Formulation development
• Industrial scale-up
• Analytical method development
• Stability studies
• Clinical trial support

Pharmaceutical Plants for Production of Probiotics and Live Biotherapeutics Aiming for Excellence and Customers’ Trust

From production to final packaging (sticks, sachets, capsules)

Clinical batches
Commercial batches (from 480 liters to 20 000 liters)
In-process controls and quality controls at each production steps

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

• Health Canada (NNHPD)
• cGMP / US FDA cGMP (21CFR111,117)
• UL, NSF, GRMA
• C-TPAT
• CFIA
• ISO 9001 / ISO 22000 & HACCP (France)
• TGA Clearance (Australian TGA clearance)
• Religious status for certain strains (e.g. Halal)

Pharma Certifications
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)

State of the art cGMP pharmaceutical plant for probiotics and live biotherapeutics production

Key numbers

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

Our-plants stsimon

Major investments of several millions euros are planned over the coming years to continue increasing our production capacities, developing our expertise and consolidating our expansion in a growing market.”

An Experienced Regulatory and Compliance Team That Understands the Particularities of Each Territory

At the forefront of regulatory updates and in direct communication with health authorities worldwide, including Health Canada, United States FDA, European Union (EFSA), Australian (TGA), Brazilian (ANVISA) our seasoned regulatory and compliance team, performs a strong leadership and is a reference in the industry.

Regulatory support

Regulatory strategy
Ingredients compliance
Clinical trials review