The path to fill-finish technology modernization and solving drug shortage problems
How do pharmaceutical manufacturing facilities modernize their fill-finish operations? How can the industry innovate to solve a chronic drug shortage problem? These were the BIG questions asked when Vanrx recently participated in articles with BioPharm International and Pharmaceutical Technology, respectively.
The two articles provide good ideas for how to address these issues.
Here they are, in case you missed them.
Vanrx is already implementing many of the ideas expressed in the articles, giving you real, pragmatic, executable ways to put them into practice.
As an equipment supplier, we can build equipment faster because we offer a standard design. The flexibility to fill different containers is built-in—not modular, but truly integrated— so facilities are agile in meeting current demand forecasts and responsive for future market changes and new product launches.
Patheon, a CDMO, expressed the dilemma of producing to forecast and the risk of building dedicated facilities in an article written in 2016. Since then, Patheon chose Vanrx’s SA25 Aseptic Filling Workcell to provide an agile filling service for vials, syringes and cartridges. The following case study illustrates how they implemented the new technology into their facility.
How does Vanrx measure up to the suggestions for fill-finish technology modernization?
Met by Vanrx?
|Advances in automation and barrier isolators, including closed gloveless systems||Yes, the SA25 Aseptic Filling Workcell is the only integrated gloveless filling system.|
|Flexibility and minimizing downtime||Yes, flexibility to fill and close vials, syringes and cartridges with minimal downtime. Product changeover in 1 hour or less.|
|Single-use product contact parts||Yes, Vanrx systems employ single-use product contact parts.|
|Clean-in-place (CIP) within barriers||Yes, very consistent CIP results within a closed isolator.|
|Robotic automation||Yes, complete automation of filling and closing process using robotics, including lyophilized products. Removes use of gloves, which require constant testing and can introduce system failure.|
|Use of nested components||Yes, Vanrx machines use pre-sterilized nested containers and closures to simplify material handling and reduce container contact. Removes the need for washers and depyrogenators.|
|Sensors and automated feedback controls||Yes, Vanrx Workcells have automated environmental monitoring. Real-time reporting is possible through control system. Machine vision guides robotics through filling and closure.|
Fifty percent of people surveyed by DME about equipment purchasing trends expressed a preference for isolators in renewing their equipment. Eighty percent of facilities intend to complete significant renewal in the next 10 years. Isolation enhances patient safety by reducing the risk of introducing particles to the product.
Robotics take isolation one step further by removing human error and adding flexibility through software. Whole systems can be reprogrammed for a new product with minimal re-tooling necessary.
The use of ready-to-use (RTU) containers and closures enhances these benefits by simplifying material handling. If a new format or container size is chosen, it does not mean the wholesale replacement of mechanical equipment to accommodate the change.
Despite protests about the cost of automation within the BioPharm article, robotic workcells have a lower cost of purchase and total cost of ownership versus conventional isolator-based filling systems. Workcells can also be built and installed faster because of a standardized design with fewer utility and support requirements.
Further, we partner with like minded companies to implement the ideas expressed in the articles in real world projects today. On the facilities side, companies like G-CON Manufacturing are producing cleanroom pods that can be dropped into warehouse space. These are ready-to-use, cost less per square foot and can be ready in six months, anywhere in the world.
All of this is in the service of being faster to market. Faster to market in conceiving and building a facility. Faster to market for future products, where production capacity is easily scalable and repeatable at global sites.
For the drug shortage issue to become a non-issue, the industry needs to reduce time and cost to build and validate facilities. This can be accomplished at both the upstream and downstream stages by choosing production technologies that minimize downtime and build in flexibility. Key markers to reach this state are equipment standardization, minimizing downtime (as close to continuous production as possible) and improved forecasting accuracy.
Vanrx was created to solve long-standing production issues like those raised in these articles. Our goal is to make it possible for every company to produce safe injectable drugs for the patient. If you would like to talk about your company’s requirements, please contact us.