EXPERT’Biome CDMO by Lallemand
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
Key figures:
- A team of 40+ R&D people
- 420+ publications
- 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
Plant certification for production of probiotics and live biotherapeutics.
- 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.
Key figures:
- 130+ employees
- 75+ years of know-how
- Producing 80 million+ sachets per year
- 20M€+ continuous investments in the last 7 years
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
- Master file and dossier preparation
- Worldwide presence in recognized organizations
- Industry expert involved in the development of policies
- Panelist in numerous trade conferences
Key figures:
- 29 drugs achieved registrations.
- 40+ approved health claims in Canada and 3 in Brazil
- 200+ food supplements approval