New York, USA – September 18, 2024 – A scientist at Creative Biolabs explains, “These live microorganisms, including bacteria and fungi, offer exciting new approaches to treat various diseases, from gastrointestinal issues like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) to more complex conditions such as diabetes, depression, and even certain cancers. Recent industry news highlights how LBPs, such as probiotics, are breaking new ground, especially with two LBPs recently receiving U.S. FDA approval—a monumental step forward. However, challenges in standardization, dosing, and safety still exist, pushing the need for specialized services that can handle the complexity of these products.”
With expertise ranging from microbial isolation to potency and stability tests, Creative Biolabs’ Analytical Development and Qualification Services for LBPs ensure that every product is optimized for clinical success.
Advanced Microbial Isolation and Screening
One of the key elements in the development of LBPs is identifying and isolating the right strains of microorganisms. Creative Biolabs manages advanced techniques that focus on screening microorganisms based on functionality, including antimicrobial activity and immune modulation, ensuring only the most promising candidates move forward in the development pipeline.
“The importance of this service is highlighted by available studies showing that certain microbial strains play crucial roles in modulating the gut microbiota and immune response.” The scientist elaborated.
Potency Testing: Ensuring Efficacy
The next big hurdle after isolation in LBP development is confirming that the microorganisms are not just surviving but thriving in their intended therapeutic roles. That is where Creative Biolabs’ potency test services come into play to provide detailed insights into the effectiveness of live microorganisms, ensuring that live microorganisms maintain their desired functional properties throughout the production process and after formulation.
Stability Testing: Maintaining Viability
Once the potency is confirmed, ensuring the stability of these microorganisms during storage and transportation is critical. Creative Biolabs tackles the issue head-on with stability testing approaches that assess the stability of live biotherapeutic products under various conditions.
“Industry reports on supply chain challenges in LBP delivery highlighted the need for better stability testing, as improper storage can drastically reduce the efficacy of live biotherapeutics. We employ advanced methodologies to guarantee that LBPs remain viable and effective, giving pharmaceutical companies confidence in the shelf-life and functionality of their products.” The scientist added.
Monitoring Microbial Contaminants: Keeping Clean
“Contamination, one of the primary risks in LBP manufacturing, can compromise both the safety and effectiveness of the product,” the scientist added, “and thus we’ve established a microbial contaminant monitoring pipeline to ensure that every step of the LBP development process is free from harmful contaminants.”
With new regulatory guidelines and heightened interest in live biotherapeutics, companies are under increasing pressure to meet rigorous standards. Creative Biolabs is not only prepared to meet these challenges but is also setting the bar for excellence in the field. Visit https://live-biotherapeutic.creative-biolabs.com to learn more.
About
Creative Biolabs is leading the charge in developing analytical services that meet the unique challenges of LBPs. Their broad range of offerings, from microbial isolation and potency testing to stability and contaminant monitoring, equips pharmaceutical and biotech companies with the tools they need to bring safe, effective LBPs to market. In 2024, Creative Biolabs’ team of dedicated scientists will attend several key industry exhibitions to share the latest advancements in biotech, including:
* September 25th, NIH Research Festival
* October 22nd, BioPharma Drug Discovery Nexus Conference
* November 4th, Annual World ADC San Diego
* December 15th, Antibody Engineering & Therapeutics (US) 2024
Media Contact
Company Name: Creative Biolabs
Contact Person: Candy Swift
Email: Send Email
Phone: 1-631-830-6441
Country: United States
Website: https://live-biotherapeutic.creative-biolabs.com
