Stability & Microbiology
Demonstrating Product Quality Over Shelf Life
Stability and microbiological testing programs establish that drug products maintain acceptable quality, safety, and performance characteristics throughout their intended shelf life and storage conditions. These studies generate data supporting specification setting, expiry date determination, and regulatory submissions while ensuring products meet pharmacopeial standards for chemical stability and microbiological quality.
Biotts provides stability and microbiological testing services from a GMP-certified facility with controlled environmental chambers and microbiological testing capabilities. Our services support pharmaceutical and biotech partners from early development through commercial manufacturing, with documentation structured for regulatory submissions where applicable.
Stability programs follow ICH guidelines (Q1A(R2), Q1B, Q5C) with testing schedules, storage conditions, and analytical methods appropriate to the dosage form, intended market, and regulatory pathway. Microbiological testing addresses pharmacopeial requirements (USP, Ph. Eur.) for sterility, bioburden, or preservative efficacy depending on product type and route of administration.
Core Capabilities
Stability and microbiological programs generate time-point analytical data, trend analysis, statistical evaluation where appropriate, and comprehensive reports suitable for CMC documentation and regulatory submissions. Stability protocols define testing schedules, acceptance criteria, and out-of-specification procedures aligned with regulatory expectations.
Explore detailed capabilities for each service area below, or contact Biotts to discuss stability and microbiological testing requirements for your program.