Alcami Capabilities Update October 2026: Analytical And Lab Services

Routine microbiological testing provides important information about product quality, but it is not the only requirement to demonstrate that a product will remain microbiologically safe throughout its intended administration and use.

For products with complex formulations, multiple-dose presentations, extended in-use periods, novel delivery systems, or unique handling requirements, microbial challenge studies provide critical evidence of a product's ability to resist or control microbial contamination. These studies help establish patient safety, support regulatory expectations, and strengthen microbiological risk assessments across the product lifecycle.

Alcami is a recognized expert in the design, execution, and interpretation of microbial challenge studies for pharmaceutical, biologic, and combination products. Leveraging deep microbiology, analytical, and regulatory expertise, Alcami develops customized, risk-based testing strategies that go beyond routine compendial evaluations to address real-world product use.

This presentation will highlight how scientifically rigorous microbial challenge programs are designed and executed; as well as provide lessons learned and challenges that may arise helping sponsors confidently demonstrate microbiological safety