Company: RPID
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001380106-25-000058
Chunk: 22

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 22
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 monitoring plates incubated for five days, which compared Growth Direct’s vision-based detection and enumeration to visual counting conducted by technicians, the Growth Direct regularly identified and counted colonies that technicians missed.

Our Growth Direct platform

We pioneered the Growth Direct platform—a combination of our novel Growth Direct system, proprietary consumables, LIMS connection software, and comprehensive customer support and validation services—to fully automate and digitize the process of MQC in the sterile manufacturing of important health care products.

The Growth Direct system

Our current, second-generation Growth Direct system, launched in 2017, reflects our deep experience with delivering automation to the MQC market. The Growth Direct system is a fully automated, high throughput system for processing MQC samples—a microbiology quality control lab in a box. The Growth Direct system contains two high-capacity incubators, an advanced imaging system and internal robotics for sample handling. The system enables walk-away bulk sample loading, holding 700 of our consumables per system. Its dual, independently controlled incubators automatically manage multi-temperature incubation protocols. Onboard imaging and vision software detects and counts microbial growth, delivering test results in half the time of the manual method. The system’s compact 57” x 39” x 95” size delivers these benefits in a footprint that allows customers to place the Growth Direct system directly in manufacturing suites of various sizes compared to the traditional method, where samples are often required to be transferred to a centralized lab. 

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Co-location in manufacturing minimizes delays to incubation and errors introduced by sample transfer to the quality control lab. The Growth Direct system brings the lab to the manufacturing floor, for automated MQC testing, anywhere in the facility or manufacturing campus.

Proprietary consumables

We offer proprietary consumables plates to capture test samples for analysis on the Growth Direct system. These applications include Environmental Monitoring ("EM"), Water ("W"), Bioburden ("BB"), and Sterility ("ST"). All types are custom-designed proprietary consumables with specific mechanical and optical features to facilitate automated handling and image processing within our Growth Direct system and have bar codes for sample tracking and data integrity. Two bar code options can be used—one generated during our manufacturing process to define the test application, media type and expiration dates, and a second generated by the Growth Direct system at time of testing to define the sample ID and LIMS reference number.

We made the Growth Direct rapid sterility application available for commercial sale and placed the first rapid sterility system at one of our existing customers in the second quarter of