Since the FDA first approved the use of gene therapy in 2017, the market for these treatments has expanded rapidly. With the aim of replacing faulty genes with healthy ones, gene therapy focuses on diseases which are either difficult or impossible to cure using more traditional pharmaceutical formulas.
In 2017, there were an estimated 391 gene therapy companies in the U.S. In 2019, nearly 100 more companies joined the fray, which now includes nearly every major player in Big Pharma, Pharma Manufacturing reports. Due to this explosive growth, many challenges have come forth for gene therapy companies across the supply chain — from new facility design to increased backlogs at contract manufacturing organizations (CMOs).
Prepare for Gene Therapy Commercialization
To prepare for that commercialization, gene therapy companies must examine their technology infrastructures, develop the appropriate standard operating procedures (SOPs), and ensure that they are prepared when FDA approvals are granted. Here’s how AdaptaLogix and NetSuite cloud ERP are helping gene therapy companies overcome those hurdles and stay the path to success:
Gives them sophisticated and scalable technology tools to run their growing entities.
Many gene therapy firms are running on QuickBooks and Excel spreadsheets but require more sophisticated tools to prepare for in-house manufacturing. Within months, a company that has 10 employees focused on researching and developing life-changing drugs can suddenly experience a 300% increase in headcount, all while needing to comply with federal regulations, prepare and undergo annual audits, adhere to SOX accounting standards, implement a GMP and 21 CFR Part 11 compliant ERP and manufacturing solution.
Helps them manage their own manufacturing.
Forced to take the do-it-yourself (DIY) manufacturing route for proprietary or lack of suitable third party contract manufacturers, gene therapy companies must implement inventory control systems, with lot traceability, and leverage advanced manufacturing systems—processes that have historically been outsourced to third parties. They must also implement their own Good Manufacturing Practices (GMP), which are the best practices set forth to ensure that manufacturers are only using approved materials and vendors that adhere to strict quality control standards.
Instills good controls.
“When a pharmaceutical batch is released at the end of production, the gene therapy manufacturer has to report all of the materials that went into that batch,” said James Neal, Founding Partner of AdaptaLogix, “and be able to prove that it was manufactured in accordance with the product’s quality standards.” A plasmid, for example, is required to be kept at a certain ambient temperature to avoid being tainted or spoiled. This product integrity must be maintained throughout the entire manufacturing process, with the ultimate goal of being able to produce an accurate record of the material’s status as it is transformed into a life-changing therapy.
Provides high levels of supply chain visibility and product traceability.
In a world where a single vial of plasmid can cost upwards of $50,000, the ERP system also automates the inventory management process and ensures that those high-cost items are accounted for, replenished, and not nearing expiration. “The cost of expired drug product is massive in an industry where companies may not know what they have in inventory at logistic providers or are uncertain of what materials are required to start production on their next batch,” said Neal. These uncertainties are costly when the product in question is worth $50,000 and may expire within a month or less.
Elevates companies toward commercialization and beyond.
For gene therapy companies, AdaptaLogix offers a NetSuite-based GMP Pharma Bundle that takes, on average, nine months to implement, depending on the company’s individual requirements. By offering a standardized solution to gene therapy companies of all sizes, AdaptaLogix is effectively democratizing technology that was once only the domain of very large pharmaceutical companies with much larger technology budgets. “Up to this point, smaller gene therapy companies couldn’t staff or justify the expense of a Tier One SAP-style system, but that was their only option,” said Michael McKenzie, Partner at AdaptaLogix. “Using NetSuite as a foundation, we go beyond what the competition’s system can do, and bring GMP manufacturing capabilities to our clients.”
As gene therapy companies grow, their technology requirements expand right along with them. For this reason, implementing a unified cloud ERP system very early in a company’s lifecycle—before manufacturing, distribution networks, and supply chains are even established—creates a solid framework to effectively support the deployment and subsequent execution of these processes. NetSuite ERP and AdaptaLogix GMP Pharma Bundle scales up as companies mature and meets the needs of its clients from Phase 1 through commercialization.