GLAC Biotech: Pioneering Probiotics on the Global Stage

As a leading probiotic contract manufacturer in Asia, GLAC Biotech is dedicated to the research and development of innovative, functional probiotics. We develop world-class strains, backed by multiple publications in international scientific journals and a growing portfolio of global functional patents each year.

Our star strain, Lactobacillus rhamnosus MP108, is a highly stable and high-yield functional probiotic that has earned significant acclaim from our clients worldwide. In a landmark achievement for both our company and Taiwan's biotech industry, MP108 received GRAS (Generally Recognized As Safe) notification from the U.S. Food and Drug Administration (FDA) in 2023 (GRN No. 1130). This recognition solidifies our position as a leader in the probiotic field.

Understanding the Significance of FDA GRAS Notification

The U.S. FDA is the governing body responsible for overseeing the safety of food, dietary supplements, and pharmaceuticals in the United States. Achieving FDA GRAS status signifies that a substance has been officially recognized for its high level of safety.

It is crucial to distinguish between a "Self-affirmed" GRAS, where a company's own panel of experts determines safety, and an "FDA Notified GRAS." For the latter, a company must submit comprehensive safety data for a rigorous review by the FDA's own expert panel. This demanding process requires over five years of preparation and a multi-million NTD investment, including extensive safety evaluations like acute toxicity, genetic toxicity, and 90-day oral toxicity studies.

Upon successful review, the FDA issues a "No Objection Letter" and a unique GRAS Notice (GRN) number—in this case, GRN No. 1130 for our MP108 strain—validating it as a premier-grade probiotic ingredient.

Clinically Proven Benefits of L. rhamnosus MP108

Originally isolated from the gut of a healthy infant, our proprietary strain L. rhamnosus MP108 is supported by 11 global patents, features in 16 international SCI journals and academic conferences, and has been validated in multiple human clinical trials.

Atopic Dermatitis Study Highlights: In a clinical study on infants with atopic dermatitis, MP108 was shown to foster a healthy gut environment and modulate the gut microbiota. These effects helped complement anti-allergy medications and significantly improve the symptoms of atopic dermatitis.

• Supports a healthy gut environment

• Modulates the gut microbiota

• Alleviates discomfort from atopic dermatitis

Allergic Rhinitis Study Highlights: Clinical research on children and adults with pollen allergies demonstrated that MP108 effectively alleviates the symptoms of allergic rhinitis and reduces nasal airway resistance, showcasing its exceptional immunomodulatory capabilities.

• Relieves occasional diarrhea and constipation

• Improves symptoms of allergic rhinitis

• Reduces nasal airway resistance

Unmatched Quality and Global Recognition

Backed by over 15 years of scientific dedication and a research team of more than 30 experts, L. rhamnosus MP108 is the result of meticulous validation through in vitro, animal, and human clinical trials. It has passed the industry's most stringent 7-hour gastric acid and bile salt tolerance tests, demonstrating superior intestinal adhesion and colonization capabilities compared to competing strains.

Beyond its FDA GRAS status, MP108 has also met the stringent safety standards in China, earning a place on the prestigious "List of Probiotic Strains Approved for Use in Infant and Toddler Foods"—the first strain from the Greater China region to receive this honor.

Setting a New Global Standard

MP108 is the first probiotic strain from Taiwan to receive a full FDA GRAS notification, placing it on par with world-renowned strains like LGG® and HN001™. This achievement positions GLAC Biotech alongside other globally respected, GRAS-recognized manufacturers such as Chr. Hansen, Lallemand, and Morinaga Milk Industry. It not only provides international companies with a superior choice of raw materials but also sets a new benchmark for Taiwan's probiotic industry, proving our capabilities are competitive with global leaders.

The GRAS notification is a testament to GLAC Biotech's R&D strength, advanced manufacturing technology, and commitment to safety and data-driven science. It is the highest honor in our field and marks a new milestone, solidifying our standing in the international market.