INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Mikart’s analytical services begin with accurate measurements of formulation characteristics and are informed by our dedicated team’s mastery of process — the precise changes that maximize your product’s performance and market adoption.

  • Realize the full potential of your cell therapy research. Experience end-to-end support to overcome developmental complexities, helping you to efficiently and safely commercialize your groundbreaking treatments.

  • Elevate production safety with high-speed detection that identifies small contaminants while reducing waste. Intuitive controls and durable design ensure long-term efficiency and reliability.

  • Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.

  • Bringing complex therapies to market requires seamless integration across development, manufacturing, and regulatory strategy to reduce risk, speed timelines, and ensure quality.