Advanced therapies deserve advanced automation
Advanced Therapy Medicinal Products (ATMPs) are exploding in terms of their importance and the number of candidates entering the clinic. These highly targeted therapies can have life-changing results, but the technologies needed to make them are lagging behind.
Conventional manufacturing isn’t up to scratch
You’re trying to develop a production process for a brand new therapy. The drug product is precious. It may have started with apheresis from a patient that will receive an autologous cell therapy. It may be the result of a viral vector transfection process where bioprocessing capacity does not mean high or predictable yields. Across every category of ATMP—cell therapies, gene therapies, gene editing products, bacteriophages, neoantigen immunotherapies—the drug product is expensive and extremely complex to produce.
What are the main goals of the production process? Our customers use phrases like “reduce cost of goods,” “maximize yields” and “least possible risk.” Yet many processes in ATMPs are still manual, including in aseptic filling, all the risk that entails.
In facilities where different drug products with their own unique requirements are being produced into different containers for individual patients, relying on operators leaves precious drug product open to human error. Barrier systems and multiple pieces of filling equipment from different suppliers also creates exponential effort and cost in the procurement, acceptance, qualification and validation of the overall system—adding more time and complexity to this already complicated process. This risk and increased complexity is the reason that manual manufacturing of ATMPs is so expensive and why patients aren’t getting access to life-saving therapies.
Automated aseptic filling helps to solve these complexities. Robotic systems remove the risk of human error as the material handling process is entirely automated. A single standardized, fully integrated system from one supplier also ensures a cohesive process that can be qualified and validated quickly. Reducing the cost and risks of manufacturing through automation makes it faster and easier to get advanced therapies to patients.
Here are a couple of examples of companies making ATMPs that are succeeding with Vanrx’s Aseptic Filling Workcells.
Adaptive Phage Therapeutics
Adaptive Phage Therapeutics (APT) is developing PhageBank, a collection of viruses to kill the most dangerous antibiotic-resistant superbugs. Their challenge is to fill multiple viruses every day in order to build a library of over 1,000+ drug products. Working with this many different small batches, APT needed a filling machine that could cycle through drug products in an agile way that did not put their highly-sensitive biologic material at risk.
Choosing the Vanrx Microcell Vial Filler allowed APT to rapidly fill multiple different drug products, or phage, matched to particular patient bacteria isolates every day. It also allowed them to freeze and store their collection of pre-maufactured viruses from PhageBank. Using a conventional system to fill viruses and requiring up to 3 days for cleaning and filling, this would have taken the company over 10 years to reach their clinical trials. With the Microcell, it was done in a matter of months.
Their advice to other companies filling personalized medicines or advanced therapies? Conventional systems just aren’t suitable anymore and if you’re not using this technology, you will fall behind.
FUJIFILM Diosynth Biotechnologies
One of the greatest challenges facing gene therapy CDMO FUJIFILM Diosynth Biotechnologies (FDB) is the diversity in how manufacturers want to make, fill and present their advanced drug products. With so many differences in formulations, batch sizes and fill-finish operations, flexibility is crucial. Maintaining high levels of quality is another essential aspect of operations. When working with live viruses, containment is needed to control contamination and to protect operators.
After a detailed and thorough research process, Vanrx’s SA25 Aseptic Filling Workcell came out on top as the most suitable solution for their needs. With the same ultimate goal to improve patient outcomes and access to life-changing medicines, FDB chose the SA25 based on minimizing risks to patients as well as minimizing product loss. The entire ecosystem of the SA25 system is based on reducing risk. Their evaluation focused on the following elements:
- There is no hazard pathway with contact surfaces;
- All components are held in nests with no stopper bowls
- Gloves ports are eliminated because sources of errors requiring human intervention are designed out of the system; and
- Only disposable, single use flow paths are used to ensure the highest level of aseptic sterility and containment.
Manufacturing for advanced therapies requires advanced automation. Ensuring a high quality process and end product is essential to give patients access to the best possible treatment but traditional manual processing systems cannot provide for this. An entire ecosystem based around automation—including material handling, container/ closure components, and decontamination systems—is the future for manufacturing advanced therapies.
Looking to learn more about how automated systems can advance your ATMP manufacturing operations? Get started with Vanrx today and let us introduce you to the companies already seeing the difference.