Company: RPID
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001380106-25-000058
Chunk: 24

Company: RAPID MICRO BIOSYSTEMS, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 24
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 improving efficiency. Moreover, the LIMS connection eliminates the need to use paper in the lab and delivers information to stakeholders in a secure manner, designed to enable compliance with data integrity regulations.

Our service team works directly with customers’ IT teams to help integrate Growth Direct software into their LIMS for seamless connectivity.

Validation services

As part of our customer support experience, we offer full validation support to ensure customer success with the Growth Direct platform. Through this offering, we help our customers validate their Growth Direct system for full routine use faster, typically in just three to nine months after the Growth Direct system is placed and installed, and develop confidence in the operation of our platform.

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Support begins prior to system purchase when our sales representative brings in one of our validation experts for consultation about specific application requirements. Our validation team offers a complete array of documents and services to support validation efforts, including:

•Installation Qualification

•Operational Qualification

•Performance Qualification

•Time-To-Results Qualification

•21 CFR Part 11 Assessment

•Method Qualification/Method Suitability

Once initial systems are validated, our customized validation approach allows customers to quickly validate follow-on systems through a Technical Transfer Method, facilitating faster adoption throughout their site network.

Customer support

We offer full 24/7 maintenance support via annual service contracts. Purchase of the Growth Direct system comes with a one-year warranty, after which customers may purchase annual service contracts. Our maintenance support package offers access to a staffed online and phone help desk with knowledge base, remote management and troubleshooting, and a 24-hour response time from our on-site field service engineer team.

Integration with MODA® Platform

In the fourth quarter of 2024, Lonza, a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, published a white paper discussing a recent collaboration involving our Growth Direct technology. Lonza sought to achieve paperless quality control laboratories using automated digital systems. As part of this ambition, Lonza sought an end-to-end automated solution to optimize EM at four of its cell and gene therapy manufacturing sites across North America, Europe, and Asia. Our Growth Direct system was successfully integrated with Lonza's MODA-EM Module to combine paperless processes with automated microbial enumeration for pharmaceutical quality control. The MODA-EM is a software module used by many pharmaceutical companies that enables paperless data collection and management for quality control microbiology. We believe this integration showcased the compatibility of our Growth Direct platform with commonly-used technologies at our customers and potential customers and may further