Forge Boosts Efficiency and Compliance During External Collaboration

Despite impacting the lives of an estimated 30 million people in the U.S., 95% of rare diseases have no FDA-approved treatments¹. At its 200,000-square-foot manufacturing facility (“The Hearth”) in Columbus, Ohio, Forge Biologics’ mission is to increase access to safe and effective treatments for patients. Founded in 2020, the contract development manufacturing organization (CDMO) is an AAV gene therapy company focused largely on rare diseases. The faster its clients get their products into clinical trials, the sooner patients benefit from access to treatment.

Serving clients worldwide, and addressing both rare and increasingly prevalent diseases, is at the core of Forge’s business model and its commitment to meeting evolving industry needs. To reduce turnaround times, it needed to improve external collaboration during batch manufacturing, disposition, and client acceptance. If clients could start reviewing dispositions once manufacturing and quality reviews were complete, they could provide real-time feedback and approve product-impacting quality events. To achieve its goals, Forge implemented Vault Quality.

Turning the page on document change control

Among those contributing to Forge’s growth story from the beginning was Director of Quality Management, Ryan Heil. Heil’s team realized improving external collaboration would provide more visibility and agency over product-impacting deviations, change controls, and complaints.

While Forge’s customer base ranges from private biotechs to listed companies, NGOs, and foundations, all organizations focused on rare diseases know that time is of the essence: “We wanted a modern, digital-first solution and to allow our clients access to the quality system so they could accelerate their timelines from development to GMP manufacturing,” he says.

After mapping out the company’s external collaboration processes and deliverables, it became clear that clients become part of Forge’s workflows when specifying document requirements and reviewing and approving batch records and test methods. These activities added significant time because they took place in shared drives, or by email, using e-signature tools, and could involve searching for documents in legacy folder structures. It was difficult to maintain version control unless one person collated all the document changes.

Collaborating in a unified quality management system eliminates side conversations and restores version control. By changing how it worked, Forge realized it could reduce the turnaround time for reviews and approvals to deliver batch records sooner to clients. The internal project management teams could keep track of the status of batch records and obtain client signatures. Clients could track progress with investigations, review timelines, and start reviews before getting the full disposition packet.

Seamless collaboration leads to faster batch release

Comprised of only a few dozen people when it started, digital communication was a key factor in Forge’s early success. As the company grew, ensuring easy external collaboration on document changes and quality events became critical.

Forge implemented three Veeva quality applications using standard workflows and procedures: Vault QualityDocs, Vault QMS, and Vault Training. Knowing that internal and external quality reviewers would need to collaborate on documents, Veeva introduced a multi-document workflow during configuration to break out security settings, notifications, and due dates for different types of reviewers. This addressed a previous driver of delays, where internal collaborators would ‘check out’ documents blocking clients from working on them. “Collaborative authoring is a strong tool we wanted to leverage and a key selling point for QualityDocs and Training,” Heil explains.

“Collaborative authoring is a strong tool we wanted to leverage and a key selling point for QualityDocs and Training.” — Ryan Heil, Director of Quality Management, Forge Biologics

Working within a connected quality management platform ensures compliance when collaborating externally. Not only has Forge eliminated non-secure communication methods (like email and shared drives), but it’s also much easier to involve clients in change control. For example, if the team comes across a quality event, it can add clients and share information with them for quick and easy review. Clients can then provide their impact assessments of the changes within QMS. “We’re able to capture clients’ signatures on documents and major quality events that require their oversight and approval,” explains Heil.

“Using Vault Quality as a single source of truth means it’s straightforward to share reviewed and executed batch records with clients. This reduces document review and approval cycle times, improving the client experience.”

“Using a unified quality management platform is helping to reduce turnaround times for faster R&D and manufacturing. Teams of internal and external collaborators are more efficient.” — Ryan Heil, Director of Quality Management, Forge Biologics

Forge is now considering adding other solutions, such as batch release, to support client communication further: “The product development (PD) folks are asking if we can use Veeva for PD documents as well.”

On a faster path to submissions

Using a unified quality management platform is helping to reduce turnaround times for faster R&D and manufacturing. Teams of internal and external collaborators are more efficient when executing manufacturing, obtaining procedures to run new processes or equipment, and delivering QC results to disposition products. “The big benefit of having a unified quality management system that includes documents, training, QMS, and LIMS is that people can go to Veeva as the single source of truth,” says Heil.

Customers have shared positive feedback on their experiences using Vault Quality. Many were already Vault platform users and only needed limited training to get up and running. Now they can see their tasks, due dates, executed records, analytical method development, and product-specific methods in one place, clients can get their work done immediately.

The connections with Vault Regulatory Publishing also benefit Forge’s internal operations, as it can track the regulatory impact of change controls and accelerate the path to submission. Heil concludes: “Veeva is a really powerful tool. By having multiple Vaults, we’re able to identify changes from Vault Quality into Vault RIM. This way, we can track updates to any regulatory documentation we may need.”

Data to fast-track treatment

Given its quality applications share a common data foundation, Forge benefits from enhanced reporting and metrics. These capabilities help it prioritize quality events, deviations, and change controls, so it can complete its package and deliver materials swiftly to clients.

“External collaboration is a critical part of any CDMO’s business. At Forge, we’re really leveraging Vault to facilitate that collaboration with our clients, enabling faster turnaround times so patients can access treatments.” — Ryan Heil, Director of Quality Management, Forge Biologics

Soon it anticipates using reporting insights to manage projects more efficiently. Heil adds: “We’ll use metrics on task completion to identify which document types pose problems. We’ll be able to predict whether client tasks are taking longer or shorter than estimated, so we can plan projects better.”

Heil concludes: “External collaboration is a critical part of any CDMO’s business. At Forge, we’re really leveraging Vault to facilitate that collaboration with our clients, enabling faster turnaround times so patients can access treatments.”

Hear Ryan’s story in his short video.

Learn why customers benefit from Vault Quality.