Lecture 29 - probiotic Flashcards
(23 cards)
What is the typical timeline for probiotic development from discovery to market?
Approximately 2 years
What is the first step in the probiotic development process?
Strain Identification & Screening
What are the key aspects of strain characterization in probiotic development?
Genomic safety, antibiotic sensitivity, literature and legal clearance
What does safety assessment in probiotics involve?
Preclinical (animal) and clinical trials to ensure safety and efficacy
What is the purpose of stability testing in probiotic development?
Shelf life studies (real-time & accelerated), packaging design considerations
What type of trials are conducted for efficacy testing in probiotics?
Pilot and full clinical trials tailored to intended claims
In formulation development, what must match regulatory approval?
Dosage format must match clinical trial formulation
What factors influence the production strategy in probiotic manufacturing?
Capacity, cost, and control
What is the role of Quality Assurance & Control (QA/QC) in probiotic manufacturing?
Ensures product safety, consistency, and regulatory compliance
What is the goal of fermentation and manufacturing in probiotic production?
High CFU/g, genetic stability, contamination-free
What is the initial step in the probiotic fermentation process?
Seed Culture Preparation
What is the volume of the main fermentation in probiotic manufacturing?
5000 L
What happens during the harvesting and processing stage of fermentation?
Cells clarified, mixed with lyoprotectants, snap frozen, freeze-dried, milled
What are the key components of quality assurance and safety in probiotic production?
Production logs, fermentation profiles, batch numbers, microbial specifications
What type of packaging is used for the final probiotic product?
Nitrogen-sealed, high-barrier foil bags
What does GRAS status stand for in relation to probiotic strains?
Generally Recognized as Safe
What is checked for incoming ingredients in finished goods lozenge manufacturing?
Specification and Certificate of Analysis (COA) check
What process ensures ingredient uniformity in lozenge manufacturing?
Ingredient blending (3D powder blending)
What happens during the blister packaging stage of lozenge manufacturing?
Lozenges inserted into blisters, quality checks performed
What types of tests are performed during quality control sampling?
Microbial counts, hardness, friability, cell counts, flavor, water activity
What documentation is provided upon final product release?
Complete documentation and COA
What certification does the facility for probiotic manufacturing hold?
ISO 22000 certification
What is the purpose of having trained operators in the probiotic manufacturing facility?
Ensure traceability and compliance
