Company: RPID
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001380106-25-000058
Chunk: 21

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 21
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 robotic handling, microbiology, optical imaging, image analysis, data management and security, and process automation, and is supported by our unwavering commitment to the highest level of customer support.

10

Growth Direct method

The Growth Direct method relies on a fundamental property of all microorganisms—they contain cellular components required for growth, called flavins and flavoproteins, that autofluoresce, or glow, without the addition of reagents under certain frequencies of light. Our proprietary system detects microcolonies of microorganisms by illuminating them with blue-spectrum light and directing the resulting green-spectrum signal onto a Charged-Coupled Device, or CCD, chip—an array of independent photosensitive pixel elements. Our image analysis software interprets these light signals and counts the clusters of illuminated pixels representing each microcolony. The end result is an automated method that is faster and produces more reliable and accessible data than the traditional method. Our Growth Direct platform accelerates time to results by 50% or more compared to the traditional method, and reduces MQC testing to a simple two-step workflow, eliminating up to 85% of the manual steps of traditional MQC, generating significant time, operational, and cost savings for our customers.

System components and workflow

The Growth Direct system comprises two automated and temperature-controlled incubators, robotic sample transport systems, an advanced imaging system, two servers (one for system control, the other for image analysis) and associated hardware and staging required for the handling of up to 700 of our consumables.

The overall workflow of the automated Growth Direct method mirrors traditional visual plate counting assays, allowing for operator familiarity of use, ease of integration into existing MQC protocols, and a streamlined regulatory validation process.

Validation framework

We have demonstrated the accuracy, speed, and reliability of detecting microcolonies using the Growth Direct’s automated image analysis compared to conventional methods through numerous scientific studies.

Accuracy. The Growth Direct is highly accurate. Studies of the Growth Direct comparing its vision-based detection and enumeration of colonies against the MQC gold-standard United States Pharmacopeia, or USP, <61> benchmark reference set of microorganisms demonstrate that the Growth Direct delivers the same results or better as traditional, manual verification of colonies.

Speed. The Growth Direct is faster than the traditional method. Across a range of organisms of interest, the Growth Direct detects colonies in half the time or less compared to the traditional method.

Reliability. The Growth Direct is more reliable than the traditional method for accuracy of organism enumeration. In studies of environmental