Company: RPID
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001380106-25-000058
Chunk: 26

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 26
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 collaboration, such as joint development efforts for the enhancement of our products or introducing new products to be covered by the distribution arrangement.

Key advantages of our Growth Direct platform

We believe that several factors differentiate our technology and will continue to be significant drivers of customer adoption of Growth Direct:

•Faster Results at Higher Testing Throughputs and Capacity — The Growth Direct platform uniquely combines superior detection and enumeration capabilities—translating to accurate results in half the time or less compared to the traditional method—with a high-throughput, 700-sample total capacity form factor. This allows Growth Direct to offer a large-volume automated testing solution that allows for fewer investigations, more targeted interventions, and more uptime for manufacturers, thereby saving time and money.

•Increased Accuracy through Automation — The automation of both sample handling and enumeration virtually eliminates human errors from the MQC process. Samples are transferred automatically at the right time, reducing the risk of sample loss, misplacement or mislabeling. The Growth Direct platform also more reliably distinguishes distinct colonies, hence avoiding the subjectivity that human operators introduce through visual inspection of plates.

•Increased Process Efficiency — Faster time to results means faster decision-making and intervention in the event of contamination, preventing production of contaminated batches, and reducing waste and overproduction. Meanwhile, elimination of unnecessary manual labor allows skilled MQC specialists to spend time on test design, interventions, standard operating procedure, or SOP, updates and other critical tasks.

•Robust Security and Connectivity — The Growth Direct platform can integrate with existing LIMS, allowing for seamless data transfer from the system to the LIMS. This connection not only makes it easier for quality control personnel to handle and process their testing data, but it also allows other stakeholders to instantly access information critical to continued production.

•Superior Data Integrity — By maintaining accurate, complete, and intact records within their original context, the Growth Direct platform is designed to ensure the trustworthiness of data. Moreover, data reside in permanent form for the lifetime of the record, easily accessible to authorized users, which allows operators to analyze trends over time for timely, cost-saving decision-making. The system is designed to enable compliance with industry data integrity standards such as 21 CFR Part 11, which sets forth the FDA’s standards for electronic records and electronic signatures.

•High Reliability with Clear Path to Validation — The Growth Direct platform delivers the reliability that customers need for their mission-critical manufacturing processes, with a consistent record of uptime in live production use. Our platform’s reliability is further supported by our 24/7 support infrastructure and