LBPs
We offer Live Biotherapeutic Product (LBP) production, offering services from early-stage development to large-scale manufacturing. Our expertise includes strains characterization, upstream and downstream processing and formulation development. We provide a complete optimization of fermentation conditions, and purification processes to deliver high-quality, viable and stable LBP products for therapeutic and clinical applications.
END-TO-END SOLUTIONS
END-TO-END SOLUTIONS
Comprehensive LBPs production services, from research to GMP clinical trial manufacturing.
SCALABLE PRODUCTION
SCALABLE PRODUCTION
Flexible manufacturing capabilities, supporting both small-scale research batches and large-scale clinical production.
CUSTOMIZED MANUFACTURING
CUSTOMIZED MANUFACTURING
Tailored LBPs solutions to meet the specific research or clinical trial requirements.
FAST TURNAROUND TIMES
FAST TURNAROUND TIMES
Efficient processes that ensure rapid production timelines without compromising quality.
RESEARCH & GMP GRADE LBPs
RESEARCH & GMP GRADE LBPs
High-quality LBPs production for both research applications and GMP-compliant clinical use.
COMPREHENSIVE QUALITY CONTROL
COMPREHENSIVE QUALITY CONTROL
In-process analytics, final release and stability testing.
ANIMAL-FREE (TSA/BSE FREE) MANUFACTURING
ANIMAL-FREE (TSA/BSE FREE) MANUFACTURING
Use of biopharmaceutical-grade raw materials, including animal-free origin.
REGULATORY SUPPORT
REGULATORY SUPPORT
Comprehensive documentation and compliance guidance, ensuring a fully compliant CMC package for regulatory submissions and clinical trial applications.
We provide high-quality LBPs for preclinical studies, ensuring products tailored for therapeutic and vaccine research. Our solutions include small-scale fermentation, customized purification and formulation to meet the needs of preclinical testing.
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Strain selection and optimization for enhanced production
Fermentation production and scale-up to support large-scale needs
Formulation development and stability testing for optimal performance
Purification and analytical characterization of LBPs for quality assurance
Process development and optimization for preclinical study applications
We offer GMP-compliant LBP production for clinical trials, ensuring consistent quality and regulatory compliance throughout the process. Our production system is scalable and designed for clinical applications with comprehensive quality control and documentation.
GMP cell banking and fermentation for consistent production
GMP purification and DSP optimization for enhanced efficiency
Comprehensive quality control and release testing to meet regulatory standards
GMP stability studies and formulation optimization for product integrity
Sterile Fill & Finish for final product
