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iLabPower R&D Innovative Digital Platform: Paperless Solutions for Large Molecule Analysis Laboratory Testing

For large molecule drug analysis laboratories that still rely on traditional paper-based management systems, several common issues and pain points often arise, including the following:

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  1. Disorganized Management of Test Request Forms

Test request forms are often managed by batch, meaning each analyst may handle multiple forms, taking up significant space and increasing the risk of loss or sample mismanagement. Additionally, since large molecule drug testing involves numerous test items, analysts may struggle to quickly identify the specific test items and samples assigned to them within each batch of requests.

  1. Difficulty in Locating Samples and References

Large molecule drug samples and reference materials are typically stored in small, frozen packages. Managing these with paper ledgers results in large volumes of records, making it challenging for laboratory personnel to quickly locate the necessary items. Furthermore, due to strict temperature management requirements for ultra-low temperature freezers, it’s essential to minimize the number and duration of freezer openings. Therefore, personnel must quickly identify the correct storage boxes for samples and references during access.

  1. Results Reporting and COA Issuance

After analysts complete their experiments and reviews, they still need to locate the paper report forms corresponding to the relevant batches and manually enter the test results, which is time-consuming and prone to delays. The sample management team must then consolidate the results to issue a Certificate of Analysis (COA), adding further workload.

  1. Archiving and Access to Experimental Records

For completed experiments, offline records are typically managed using coded controlled paper. Once the results are reported, the experimenter must register the return of the controlled paper used. As test records accumulate, storage space demands increase, raising archive management costs. Moreover, when Out of Specification (OOS), Out of Trend (OOT), or Analytical Data (AD) anomalies occur, accessing historical records becomes more difficult and time-consuming as the number of records grows.

iLabPower’s Paperless Solution for Large Molecule Laboratories

To address these management issues and pain points, the iLabPower R&D Innovative Digital Platform, developed by NeoTrident, offers a comprehensive paperless solution for analytical laboratory management. This includes the management of sample delivery processes, an electronic laboratory notebook (ELN), and a biological sample management system, all designed to enhance the efficiency of sample management, testing, and analysis in large molecule biopharmaceutical labs.

Sample Delivery Process Management System

iLabPower SIP (Sample Inspection Procedure System)

iLabPower SIP manages the entire workflow, from setting quality standards to distributing samples, assigning test items, and issuing COA reports. It supports the automatic determination of test conclusions and COA generation, helping users streamline testing task assignments and COA organization, ultimately improving the operational efficiency of the analytical lab. The SIP system integrates seamlessly with the ELN, linking each testing task to its corresponding experimental records. Results from the ELN can be directly accessed in SIP, ensuring data authenticity, traceability, and timeliness.

Electronic Laboratory Notebook System

iLabPower ELN

The iLabPower ELN works seamlessly with the SIP system, syncing assigned testing tasks to the ELN. Analysts complete their experiments and record reviews in the ELN, and results are automatically sent back to the SIP, improving the efficiency of results reporting. The ELN includes functions such as instrument data analysis, customizable experiment templates, mobile app-based photo recording, and voice recognition, further improving the organization of experimental records. Additionally, the ELN supports online archiving and full-text search capabilities, reducing document storage costs and facilitating easy access to historical records.

Biological Sample Management System

iLabPower BIMS (Biological Information Management System)

iLabPower BIMS is a specialized product for managing biological samples, such as proteins, cells, plasmids, and strains. It provides users with a comprehensive solution for the management of biological samples in the lab. The system includes a visual interface for commonly used cryopreservation equipment (e.g., refrigerators, liquid nitrogen tanks, baskets, freezing racks, freezing boxes) and features sample retrieval and query functions. This streamlines the process of locating cryopreserved samples and reference materials, reducing the number of times refrigerators or liquid nitrogen tanks need to be accessed, which helps maintain sample stability by avoiding temperature fluctuations.