Case Study: BioBridge Global Connects Digital Manufacturing and Quality Management

Summary

Biobridge Global is a regenerative medicine enterprise focused on integrating donor-to-patient services to enable biotherapeutic solutions. The company operates through three subsidiaries, each handling different client needs. With a mission to enhance lives through the power of human cells and tissues, Biobridge Global emphasizes quality and customer service. They have streamlined operations by automating processes, reducing manual errors, and improving efficiency with electronic batch records. Their quality management system ensures consistency across the organization, promoting a culture of quality that strengthens client relationships and sets them apart in the competitive healthcare industry.

Takeaways

• 😀 Biobridge Global is a regenerative medicine enterprise focused on providing donor-to-patient services for biotherapeutic solutions.
• 😀 The company is made up of three operational subsidiaries, each managing different aspects of client needs, creating a competitive advantage for offering all services in one place.
• 😀 Biobridge Global's mission is to save and enhance lives using human cells and tissues.
• 😀 New employees are reminded of the importance of ensuring quality and customer service to donors, as the business starts with the gift of blood or tissue.
• 😀 The internal quality department ensures the safety and readiness of products for hospital partners in a highly regulated environment.
• 😀 Consistency in documentation and operations across three different units is critical, and Master Control helps achieve this despite different activities.
• 😀 Automation has been a significant initiative in recent years to reduce manual processes and increase processing capacity, especially with Master Control's customization capabilities.
• 😀 Electronic batch records (EBRs) have replaced manual processes, significantly reducing errors and improving efficiency for scientists, especially when dealing with large, complex records.
• 😀 The time spent on categoric tissue review has decreased from an hour and a half to just 5-15 minutes thanks to the use of EBRs.
• 😀 Integrating EBRs with the quality management system ensures that only trained personnel can access specific processes, which enhances accountability and quality control.
• 😀 Master Control provides a unified language for the organization, reinforcing a culture of quality through its use in documentation, training, and quality management.
• 😀 The consistency in quality management with Master Control plays a critical role in building trust with customers, potentially influencing their decision to do business with Biobridge Global.

Q & A

What is the primary focus of Biobridge Global?

Biobridge Global is a regenerative medicine enterprise that integrates donor-to-patient services to enable biotherapeutic solutions.

How does Biobridge Global manage its operations?

Biobridge Global consists of three operational subsidiaries, each managing different aspects of services that clients can leverage.

What is the mission of Biobridge Global?

The mission of Biobridge Global is to save and enhance lives through the healing power of human cells and tissues.

What responsibility does Biobridge Global owe to donors?

Biobridge Global owes its donors two things: great quality and great customer service.

What challenges does Biobridge Global face in maintaining consistency across its units?

Biobridge Global operates in a highly regulated environment with three different operating units, making it challenging to maintain consistency across different activities and documentations.

How did Biobridge Global transition from manual processes to automation?

Biobridge Global undertook an initiative to automate as much as possible to increase processing capacity and better support its customers. This involved using MasterControl's customization capabilities.

What problem does the electronic batch record (EBR) solve?

The electronic batch record (EBR) has significantly reduced the risk of manual entry errors and ensures that scientists can focus on their work without worrying about entry mistakes.

How much time was saved in the tissue review process using automation?

The time required for the tissue review process has been reduced from 1 to 1.5 hours to roughly 5 to 15 minutes after automation.

Why is linking EBR to the quality management system valuable?

Linking the EBR to the quality management system ensures that documentation, training, and access control are streamlined. It also helps track if individuals are trained before they can access certain batch records.

How has MasterControl impacted the company culture at Biobridge Global?

MasterControl has unified the company's language, ensuring consistency and enabling Biobridge Global to build a culture of quality. This has played a crucial role in communicating with customers about GMP (Good Manufacturing Practices).