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Sanyou Biopharmaceuticals: Accelerating Innovation through Digital Transformation

Founded on July 08, 2020, MediLink Therapeutics is an innovative drug development company focusing on antibody-drug conjugates (ADC) and related technologies. MediLink has developed the latest generation of Tumor Microenvironment Activable Linker-payload (TMALIN®) novel ADC platform technology with independent intellectual property rights, which can achieve high DAR value homogeneity with stable coupling. Further improve the therapeutic window of ADC drugs and enhance the therapeutic effect of ADC drugs against tumors, aiming to bring better treatment plans for cancer patients around the world.

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Elevating Innovation: How PackGene Biotech Streamlined R&D with Digital Data Management

Founded on July 08, 2020, MediLink Therapeutics is an innovative drug development company focusing on antibody-drug conjugates (ADC) and related technologies. MediLink has developed the latest generation of Tumor Microenvironment Activable Linker-payload (TMALIN®) novel ADC platform technology with independent intellectual property rights, which can achieve high DAR value homogeneity with stable coupling. Further improve the therapeutic window of ADC drugs and enhance the therapeutic effect of ADC drugs against tumors, aiming to bring better treatment plans for cancer patients around the world.

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Medilink Therapeutics: Revolutionizing ADC Drug Development with iLabPower PM, ELN, and AI-Driven Digital Solutions

Founded on July 08, 2020, MediLink Therapeutics is an innovative drug development company focusing on antibody-drug conjugates (ADC) and related technologies. MediLink has developed the latest generation of Tumor Microenvironment Activable Linker-payload (TMALIN®) novel ADC platform technology with independent intellectual property rights, which can achieve high DAR value homogeneity with stable coupling. Further improve the therapeutic window of ADC drugs and enhance the therapeutic effect of ADC drugs against tumors, aiming to bring better treatment plans for cancer patients around the world.

experiment-biotechnology-with-chemistry-science

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.

Scientist in protection suit holding sample of infected blood with coronavirus in test tube. Doctor working with various bacteria and tissue, pharmaceutical research for antibiotics against covid19.

8 Security Issues to Consider When Selecting an Electronic Lab Notebook (ELN)

In a SaaS deployment model, software providers host the software on cloud service providers’ servers. Users purchase appropriate licenses through the SaaS provider to access the software and its associated services. There is no need for users to install, deploy, or upgrade the software on their own systems; they simply log in to enjoy the convenience of its functionality.

 

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Since services and data are hosted in the cloud rather than on local servers, users may worry about whether their data is adequately protected. In this article, we discuss the key security concerns associated with SaaS and explain how to assess the security capabilities of SaaS providers when selecting a SaaS-based ELN, focusing on aspects like basic security, environmental security, application security, data security, compliance, and the division of security responsibilities.

  1. Public vs. Private Cloud Deployment

Public cloud platforms generally offer greater availability, security, and scalability compared to private cloud platforms. It’s recommended to prioritize well-established public cloud platforms such as AWS, Ali Cloud, or Microsoft Azure, etc.

  1. Security Management Qualifications of Third-Party Providers

When selecting a SaaS platform, it’s essential to assess the basic security capabilities, protection measures, and qualifications of the third-party SaaS provider.

Take AWS as an example. AWS is a globally recognized cloud platform that holds top security certifications, including ISO27001. AWS also adheres to strict data protection standards such as GDPR compliance, and provides services that meet numerous regulatory requirements globally. AWS security measures include physical and environmental security, baseline security, disaster recovery, and business continuity. AWS is widely regarded as one of the most secure and trustworthy cloud platforms on the market.

All business platforms of iLabPower Innovation Cloud Community are deployed on the AWS IAAS platform, utilizing AWS services such as computing, networking, and storage. The iLabPower Innovation Cloud Community relies on AWS’s robust security solutions, including AWS’s cloud firewall, to ensure top-level network security, comparable to the security measures used by AWS itself.

  1. Security Measures for SaaS Applications

The security of the SaaS platform does not automatically extend to the SaaS applications. The applications themselves must have robust security measures in place. For example, in the iLabPower Innovation Cloud Community, SaaS products implement security at various levels: network, database, environment, personnel, and operating systems. Key measures include:

(1) User Access

  • Access Interface Security
    1. Secure https protocol (SSL encryption) is employed.
    2. URL encryption via algorithms.
  • Privilege Security
    1. Login passwords are encrypted, and each account is linked to a specific device.
    2. Role-based authorization limits access based on employees’ business system roles.
  • Access Control
    1. Unique accounts for employees, preventing login by departed staff.
    2. Error protection mechanisms for login credentials.
    3. Audit logs and access records are backed up for auditing purposes.

(2) Data Security

  • Ensuring read-write separation for data integrity.
  • Utilizing a high-availability system with hot standby on two servers.
  • Creating distributed databases to avoid resource bottlenecks.
  • Implementing lightweight distributed file systems for mass storage and load balancing.
  • Regular system inspections, data backups, and anti-tampering measures.
  1. Organizational and Personnel Security

Organizational Security: The Innovation Cloud Community team consists of dedicated security teams across design, R&D, and maintenance.

Personnel Security: Employees adhere to relevant laws and policies, and have the knowledge and expertise to perform their duties securely.

Delivery Security: Security is ensured throughout the product lifecycle, from design to deployment and maintenance.

R&D and Maintenance Security: The R&D and maintenance teams work collaboratively on the platform’s architecture, business logic, and ongoing security improvements.

Disaster Recovery and Business Continuity: The system includes disaster recovery plans to minimize service interruptions and data loss.

  1. Regular Penetration Testing

SaaS platforms must regularly conduct penetration tests and provide security reports from accredited security vendors.

  1. Data Privacy and Regulatory Compliance

All data on a SaaS platform, including administrative access logs, should be regularly audited. Compliance assessments help ensure adherence to regulations and appropriate security protocols.

The ownership of user data on a SaaS platform remains with the user. SaaS providers cannot use or sell the data without user consent, and are responsible for securely destroying historical data when no longer needed. SaaS providers also bear responsibility for compensating users in case of data breaches or losses.

iLabPower Innovation Cloud Community’s Privacy Policy clearly outlines how user data is collected, used, stored, and protected, offering transparency and control to users over their data.

  1. Multi-Tenant Data Segregation

SaaS is based on a multi-tenant architecture, where data from different users may be stored in the same environment. Providers must ensure strict data isolation, preventing one user from accessing another’s data. In the case of AWS, network isolation is implemented for each deployment, and measures like trusted packet filters, rate limiting, and anti-spoofing protect tenant data.

For example, communication between virtual machines (VMs) is always routed through trusted packet filters. VMs cannot capture network traffic that is not destined for them. AWS further ensures that VMs within a virtual private network have isolated address spaces that cannot be accessed by external VMs unless specifically configured.

  1. Division of Security Responsibilities

In the SaaS model, security compliance responsibilities are shared between the SaaS provider and the customer. For instance, if a security issue arises due to a vulnerability in the application system, the responsibility lies with the provider. However, if the issue results from weak passwords or identity theft by the user, the responsibility falls on the tenant.