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ValGenesis Case Study: Theragent

To drive growth and become a premier CDMO, Theragent needed to get their state-of-the-art smart manufacturing facility up and running as quickly as possible without compromising safety or compliance. This would require a considerable validation effort. Chief Operating Officer Jeff Masten explains why the company wanted ValGenesis VLMS from day one of operations to achieve and maintain a continuous state of validation and secure confidence among clients who entrust them with the care of their assets.

In the spirit of Pharma 4.0, a greenfield CDMO sees investment in a digitized validation lifecycle management system (VLMS) as key to accelerating innovation and time to market.

Day One Compliance

Every startup launches with a vision, a shared passion, and the drive to create something great. That has certainly been the case with Theragent, a California-based cell therapy biotech startup specializing in cell and gene therapies for patients with life-threatening conditions. The company is greenfield, meaning everything it is building—from state-of-the-art facilities to processes to company culture—is from scratch.

Going greenfield has its advantages. One of the biggest is the opportunity to build a custom facility. The possibility to leverage digital automation and other smart factory capabilities from day one that vastly improve efficiency, compliance and manufacturing performance is another.

Implementing a digital validation lifecycle management solution before a company opens its doors is rare. With big ambitions and little margin for error, it can seem counterproductive to spend resources implementing software when building your facility and workforce consumes the bulk of your time. Any startup appreciates the benefits of digitalization. But few have the foresight to recognize the compounding interest of business efficiency, time and cost savings, and regulatory compliance when digitization is baked into the startup plan. These are considerable advantages in the highly competitive CDMO space. Theragent recognized this early on, according to Chief Operating Officer Jeff Masten.

"As part of our business strategy, the executive team spent a lot of time defining who we wanted to be and how we wanted clients to perceive us,” said Masten, who has four decades of experience working in the life sciences. "We all agreed that we wanted to come out of the gate being GMP compliant, and we wanted to make it a competitive advantage. There was no way this was going to happen if we relied on paper-based validation."

Theragent
Customer Profile

Theragent is a biotech startup CDMO focused on developing and manufacturing cell and gene immunotherapies to treat cancer and rare diseases.

Mission

To manufacture and deliver high-quality, reliable and value-added therapeutic solutions for biopharma clients and patients.

Headquarters

Arcadia, California

We all agreed that we wanted to come out the gate being GMP compliant, and we wanted to make it a competitive advantage. There was no way this was going to happen if we relied on paper-based validation.

Jeff Masten

COO

Bypassing the Challenges of Paper-based Validation

The validation requirements for a startup CDMO are immense. Virtually everything—equipment, instruments, methods, processes, and the manufacturing facility itself—must be validated to ensure its design, installation and operation adhere to GMP regulations. This validation consumes considerable time and resources, particularly when validation is conducted on paper in disparate systems through manual processes.

The core issue: paper-based validation is prone to human error. Manually creating, routing, approving and retrieving documents, protocols and reports is tedious and jeopardizes data integrity, opening up regulatory vulnerabilities. It also stifles innovation and delays time-to-market.

As an industry veteran, Masten experienced these challenges first-hand. He is determined that history will not repeat itself at Theragent.

"Validation plays such a key role in any new life sciences company, and I know from experience that paper-based validation is a huge bottleneck. 'I need this piece of equipment, or I need this cleanroom, or I can't store my materials in the freezer because it hasn't been validated' are common complaints—everybody is waiting on validation," said Masten. "From day one, we were committed to resource validation properly so these delays wouldn't happen."

Industry research suggests that validation activities consume 20% of every project. If a new CDMO takes two years to build its facilities and become operational, it will spend approximately five months of that time validating. Digitizing these efforts with ValGenesis cuts that time in half, which is significant in the intensely competitive CDMO space. If a manufacturing line is down for just one day, it can cost the company, and its clients, millions of dollars. Worse, it can delay the delivery of life-saving therapies to patients who desperately need them. That is unacceptable to Masten.

"In manufacturing, things happen; people make mistakes," said Masten. "But in our business, patients are waiting, so every day counts. A mistake or delay could mean that a critically ill patient doesn't receive the drug they desperately need. That's not acceptable to me."

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The two FDA investigators conducting the inspection were familiar with ValGenesis and liked the system. They were pleased we had a standardized tool for validation management. That helped us tremendously.

Jeff Masten

COO

The Selection Process

When discussing why the company chose ValGenesis over other vendors, Masten said the decision was easy. He had used ValGenesis at his former company, a large biopharmaceutical organization where he served as vice president and quality site head. He was impressed with the level of control and standardization ValGenesis offered and the overall robustness of the system, particularly its auditing capabilities. Other vendors did not provide the same level of functionality or industry expertise.

ValGenesis empowers users to standardize protocols and reports, enforcing consistency in the validation process through controlled templates and workflow standardization. Configured and approved risk assessments guide users through decisions trees that can be tailored to customer-specific compliance and quality requirements but still adhere to Theragent's own quality standards.

In addition, ValGenesis provides a comprehensive auditing function that tracks the creation, modification and deletion of records identifying the user with the date and time stamps the action took place. All validation records and associated audit trails are managed in one system for simplified, faster preparation for internal or external audits and inspections. Since CDMOs are audited frequently, staying audit-ready is critical to minimizing business disruption.

"I hosted an FDA inspection at my former company," said Masten. "Seeing the outputs the ValGenesis system provided sold me on the solution. The two FDA investigators conducting the inspection were familiar with ValGenesis and liked the system. They were pleased we had a standardized tool for validation management. That helped us tremendously."

Masten expects Theragent clients will be equally pleased that the company standardizes on the same system used by 30 of the world's top 50 life sciences companies. Customer focus is a core competency at Theragent. The company is committed to meeting customer expectations with on-time delivery of products in compliance with regulatory requirements and quality expectations. He believes investing in digitization will help them achieve this goal.

"When clients come on-site, we want to have the same tools that larger, more established companies are using,” said Masten. "We want them to leave saying, 'Wow, you would think these guys have been open for years.' It's a competitive industry and having a digital validation tool is a way to set ourselves apart."

Theragent has also implemented a quality management (QMS) system, ERP system and is evaluating laboratory information management systems (LIMS). Although the company has no immediate plans to integrate ValGenesis with its QMS or ERP system, ValGenesis VLMS can integrate with other systems of record through its comprehensive API stack.

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Our employees don’t want to push paper. They want to change our world and transform medicine. We want to make sure they have the tools they need to do it.

Jeff Masten

COO

The Implementation Process

Theragent saved time and money because they did not have to migrate legacy data (another advantage of digitizing early). According to Theragent’s Quality Director, Site Head Sang Yoon, the validation team spent most of the implementation period configuring the system.

"ValGenesis is such a robust, highly configurable tool," said Yoon. "We did many configurations, but the ValGenesis implementation services team was always willing to jump on a call to resolve any issues we had."

Like Masten, Yoon was already familiar with ValGenesis. He had used the system at his previous company and was impressed by the efficiency gains—a 50% reduction in validation costs and cycle time and a 50% increase in productivity. Yoon expects Theragent will experience similar gains.

According to Yoon, Theragent’s commitment to digitization was one of the reasons he joined the company. Tools like ValGenesis make an employee’s job easier, freeing them from tedious, non-value-added task so they can perform engaging work they are passionate about.

Theragent recognizes that building a great workforce culture starts with giving employees the tools they need to succeed and achieve a better work/life balance.

"We’re attracting some of the best talent in the industry, and I believe our commitment to Pharma 4.0 and digitization is a big part of that," said Masten. "Our employees don’t want to push paper. They want to change our world and transform medicine. We want to make sure they have the tools they need to do it.”

ValGenesis is Helping Theragent Build the Facility of the Future

Theragent spent 12 months planning its state-of-the-art facility. A range of innovative features have been incorporated into the design including four large ISO 7 clean rooms. The clean rooms house eight biological safety cabinets that operate in an ISO 5 background. All clean rooms will be on single pass air to prevent contamination. And because the facility is completely electronic, the risk of human error has been virtually eliminated.

ValGenesis’ validation management system will provide this CDMO of the future with a highly automated, visible, real-time, compliant system that will minimize the potential for GMP non-compliance, while accelerating innovation and time to market.

Industry Insights

As pharmaceutical outsourcing continues to grow and the competition intensifies, the modern contract development and manufacturing organization (CDMO) has become a vital source of drug development and delivery. Biotechnology companies see CDMOs as extensions of their development and manufacturing departments and a true partner in getting their products to market. To win in an industry where speed defines success, CDMOs must embrace innovative technologies that can save them and their clients valuable time in getting life-changing medicines to market without compromising safety or compliance. Modernizing the collection and management of validation data is a critical step toward that goal.

Key Regulatory Benefits

  • FDA 21 CFR Part 11 and cGMP compliance
  • Minimize data integrity issues (ALCOA driven)
  • Centralized change control
  • Risk-based approach to validation
  • Definition and protocol development

Reach out to schedule a free, personal demo of the ValGenesis VLMS. We’ll show you our product in-depth and share our experience to identify the perfect solution for your organization.

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