San Francisco, March 14, 2023: ValGenesis, Inc., the market leader in enterprise validation lifecycle management solutions, announced that Continuus Pharmaceuticals, an end-to-end integrated continuous manufacturing (ICM) company, successfully went live with the ValGenesis Validation Lifecycle Management System (VLMS) to efficiently manage validation processes across the company as 100% digital.
Continuus Pharmaceuticals is a spin-out company from a multi-year collaboration between MIT and Novartis. With ICM, the company is improving the affordability and accessibility of pharmaceutical products globally by exploring advanced manufacturing paradigms that accelerate the development of raw materials and APIs to final dosage forms.
Bypassing the Challenges of Paper-based Validation
“Even working in a hybrid of paper and digital paradigm, our validation processes were still cumbersome. We performed due diligence and studied several validation lifecycle management systems. The ValGenesis VLMS met or exceeded all of our requirements with only minor configuration to the COTS (commercial-off-the-shelf) offering. It delivers enterprise-grade digital validation technology that can be rapidly deployed," says Devin Donahue, Head of Quality at Continuus Pharmaceuticals. He was impressed with the robustness of the system and the level of control and standardization it offered, including its auditing capabilities. "Other vendors did not have the same level of functionality or industry expertise. We are very happy with our choice."
Accelerating Innovation and Time to Market
As a fast-growing small business focusing on continuous manufacturing of pharmaceuticals, speed to market is priority but the validation requirements are immense. For example, their goal is to be able to manufacture different drug products, and they needed an electronic solution that could determine the disposition of their assets while switching between product lines. "From a modular build perspective, we needed the ability to quickly pivot from one product line to the next while ensuring that all equipment remained validated. ValGenesis VLMS is helping us do all this and more," Devin says.
The company had commenced change control procedures in its quality management system but quickly handed the task over to the VLMS. "We let ValGenesis VLMS do all the work because it easily tracks and assesses the impact of changes to any system. Furthermore, the generated impact assessment report and associated deliverables can be moved to a site's change control process and further integrated into other processes. So, the question is: How can a company develop such a completely integrated system without spending tens of millions of dollars upfront? The answer: By working with a partner like ValGenesis whose proven solution is both comprehensive and affordable,” Devin says.
Single System for All Validation Needs
Kavya Vanamamulai, head of computer system validation (CSV) at Continuus Pharmaceuticals, is excited to do everything in a single system. "At a previous workplace, we had multiple systems – one to perform assessments, one to test applications, one to author, review and approve documents, and so on. It was tedious. With ValGenesis VLMS, the headache of logging into multiple systems is gone."
Protocol execution is a standout feature. In paper-based or hybrid systems, tracking or determining progress is extremely difficult once a protocol is issued in the field. "With the ValGenesis VLMS, protocol execution is transparent. We can execute and view protocols, and trace issues, impacts, and progress. In addition, validation records and associated audit trails are all managed in a single system. As a result, preparing for internal or external audits and inspections is simpler and easier," Kavya says.
"Validation lifecycle management applications are the backbone of regulatory compliance, ensuring that the products and processes we rely on are thoroughly tested, documented, and validated to meet the highest quality standards. By streamlining the validation process and providing a centralized platform for managing data, ValGenesis has empowered our organization to achieve our goals with greater efficiency, accuracy, and confidence." says Salvatore Mascia, CEO of CONTINUUS Pharmaceuticals.
"Continuus Pharmaceticals' success with ValGenesis VLMS validates our vision of providing affordable, unsurpassed enterprise-class digital validation technology," says Dr. Siva Samy, CEO at ValGenesis. "By digitizing with ValGenesis VLMS, companies greatly increase the speed and efficiency of their manufacturing process by cutting validation cycle time in half. We look forward to growing this relationship and meeting all our customer’s validation needs.”
Creating the Facility of the Future
Driven by ValGenesis VLMS, Continuus Pharmaceuticals has implemented computer system validation, facilities, equipment, and utility validation. ValGenesis VLMS is the system of record for their engineering team and will subsequently be expanded to other teams. ValGenesis is providing Continuus Pharmaceuticals with a highly automated, real-time, compliant system that minimizes the potential for GMP non-compliance while competitively accelerating time to market.
About Continuus Pharmaceuticals
CONTINUUS is leveraging a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), which will transform and streamline the supply chain of pharmaceuticals, by delivering high quality lower cost drugs "on-demand." ICM was initially developed through a $65 M joint research project between Novartis and MIT. With ICM, CONTINUUS will transform the pharmaceutical industry by offering next generation manufacturing technology to this industry. For more information, visit Continuus Pharmaceuticals website.