Using viral vectors to deliver genetic payloads to cells, gene therapy is a pivotal advancement in the field of medicine and biopharmaceuticals. It involves modifying or manipulating genes within an individual's cells to treat or prevent disease. It can be used to treat prevalent and rare diseases and is even used for personalized medicine.
You’re the expert in your gene therapy. But moving your adeno-associated virus (AAV), lentivirus, or adenovirus therapeutic through all the steps from cell culture to final product is a complex process (Fig 1). An experienced service provider can help accelerate the development and manufacture of your therapy. Whether you need assistance with one step in your workflow or need a complete end-to-end solution, Cytiva is ready to lend a helping hand.
Fig 1. The major steps of a viral vector workflow
Process development and technical support
Designing a robust process for your gene therapy is key achieving high yield and quality of your final product. If you’re struggling with process development or simply don’t have the resources to do it in house, Fast Trak™ process development services could be just what you need.
Fast Trak™ services can design a full end-to-end process with optimization or can assist with any part of your upstream or downstream process. For upstream, they can assist with both adherent and suspension cell culture systems. You can get help with scale up, analytical assays, and more. And downstream services include (but are not limited to) proof-of-concept design, resin screening and optimization, and mechanistic modeling. The Fast Trak™ team can then help with tech transfer back to your own site. The team also offers training and education to help your personnel develop skills and gain knowledge.
Cytiva has Fast Trak™ centers in Asia, Europe, and North America. The service you receive is fully customized to your needs, and you’ll receive comprehensive support from experienced scientists.
Contact the Fast Trak™ services team
Operator training, troubleshooting, and on-site support services
The Cytiva Fast Trak™ teams work in centralized locations, but sometimes you want help to come to you. And that’s what our Field Application Specialists (FASs) do.
Field Application Specialists are scientists with extensive knowledge of our products and strong backgrounds in gene therapy processes. They travel to client sites to help with equipment training, troubleshooting, and optimization. To fully capitalize on their time at your site, they will meet with you virtually first to understand your needs. They will then develop a plan and send it to you before they arrive. That way, you know what to expect and can have consumables ready. With everything set, your FAS will get straight to work as soon as they enter your lab.
After your FAS is sure that you are comfortable, they’ll leave your lab but won’t leave your life. You’ll still be able to reach them for additional support and more virtual meetings. And you can have additional visits if needed. Like Fast Trak™ support, FAS support can be for one or two parts of your workflow or for your entire end-to-end process.
Find a Field Application Specialist
Digital solutions
In addition to our human support team, Cytiva also has a digital support team.
Bioreactor scaler for upstream optimization
The Bioreactor Scaler is an in silico tool that allows you to achieve seamless bioprocessing scaling from process development to biomanufacturing scale. Digital cell culture scaling eliminates the manual trial-and-error approach, allowing users to better predict bioreactor settings based on scaling parameters and bioreactor and cell line characteristics. The Scaler can:
- Predict process parameters
- Save inputs and calculations
- Visualize alternatives in design space
Using the Bioreactor Scaler, you’ll save time, accelerate development milestones, and have confidence on insights of the process while reducing costs. The standard version of the Scaler is free to use, while the pro version adds many powerful features.
Request a Bioreactor Scaler pro demo
GoSilico™ chromatography modeling software
Another in silico modeling tool available to you is GoSilico™ chromatography modeling software. This software reduces the number of experiments you must do by simulating thousands of purification conditions in a few hours. The software uses mechanistic modeling to:
- Simulate preparative liquid chromatography processes with a computer
- Create predictive models of downstream processes using mechanistic modeling
- Enable increased process understanding for smarter and faster process development
- Model wide range of molecules and applications from early to late-stage process development, scale-up, troubleshooting, and chemistry, manufacturing, and controls (CMC)
In viral vector workflows, GoSilico™ software has been used to optimize AAV full/empty particle separation with anion exchange chromatography.
Request a demo of GoSilico modeling software
OptiRun™ Connect real-time digital monitoring services
OptiRun™ Connect service is a cloud-based tool for real-time equipment monitoring. The tool allows you to anticipate maintenance needs and respond quickly to problems, which can substantially reduce operational risks and costs. With OptiRun™ Connect, our engineers remotely monitor equipment and access log files in real-time, ensuring quicker diagnosis of potential issues. You will receive expert, remote support within 2 hours of an alert. If an onsite visit is required, our advanced technology makes sure our engineers arrive fully prepared with the necessary parts and expertise, achieving the fastest resolution possible. With OptiRun™ Connect, resolution time is reduced by 50% (Fig 2).
Fig 2. Instrument alerts are automatically sent directly to Cytiva online support center allowing faster resolution of issues.
OptiRun™ Connect service is available for many products offered by Cytiva including the ÄKTA ready™ chromatography system and the ÄKTA readyflux™ TF system, two systems popular with our gene therapy customers.
Watch a video about OptiRun™ Connect services
Automation solutions
Each system in your gene therapy workflow generates a huge amount of data. Collecting, organizing, and analyzing that data is extremely difficult to do manually. The Figurate™ family of automation software helps you manage this mountain of data and makes sure that the data are validated, compliant, and stored in a centralized place. The benefits of using Figurate™ software include:
- Improved quality and yields by increasing throughput and optimized uptime
- Increased safety and reduced risks by reducing manual intervention and minimizing cybersecurity risks
- Optimized staffing by increasing employee efficiency and allowing easier maintenance and training
- Speed and flexibility during scale-up and scale-out
Whether you’re interested in stand-alone automation for individual systems or want centralized automation connecting all your systems, Figurate™ software has you covered.
Explore Figurate™ software options
Operator training solutions for gene therapy manufacturing
Operators play a critical role in the success of your manufacturing batches. One operator error, no matter how small, may result in a deviation that can cost valuable time and money. In the best case, the deviation may cause a slight delay. However, low-yield, rescheduled, or even lost batches are not uncommon.
Many traditional operator training programs consist of two parts. First, operators read and acknowledge standard operating procedures (SOPs) or similar manufacturing instructions. Then, operators receive on-the-job training by shadowing experienced peers as they perform the role.
In contrast, our modern training programs use engaging training tools that address the multiple learning styles of adult students. Online access to 3D, interactive product and process videos provide critical foundational knowledge. Next, students dive deep into the equipment to learn the key components and their functions as well as see step-by-step videos that demonstrate operational techniques. Finally, students enter a virtual environment where they can practice the steps required to set up, operate, and shut down the equipment.
Combining modern digital training tools with traditional methods mitigates the risk of deviation by training operators faster and more effectively.
Manufacturing platform solutions
Setting up your gene therapy manufacturing facility can be difficult, but you can simplify the process by using a platform system. Cytiva has two related, modular biomanufacturing solutions designed to enhance the efficiency, scalability, and flexibility of biopharmaceutical production: FlexFactory™ and KUBio™ systems.
FlexFactory™ is a versatile, modular, flexible, and configurable biomanufacturing platform that uses single-use technologies and automated systems to enable efficient biopharmaceutical production. With over 170+ installations, the components of the system are designed to fit your existing facility. The FlexFactory™ platform offers flexibility in production by allowing the integration and reconfiguration of bioprocessing components. This modularity supports seamless scaling from clinical to commercial production. To enhance your speed to market, Cytiva offers the Batch360™ service that has the potential to reduce time taken to develop the single use solutions by up to 50%.
KUBio™ is a prefabricated, turnkey modular facility aimed at providing ready-to-use biomanufacturing spaces and future-proofing any capacity expansions by allowing easy additions of yet-to-be-developed products or technologies. The facility integrates all necessary production and quality control systems within prefabricated structures (Fig 3). The facility is engineered for rapid deployment and is optimized to reduce the time and costs associated with traditional construction.
Fig 3. Workers install part of a KUBio™ system.
You can think of the KUBio™ system as a set of building blocks that can be attached any way you want. Inside each block are parts of the FlexFactory™ system custom arranged for you. Both FlexFactory™ and KUBio™ are intended for companies needing to establish or expand biomanufacturing capabilities quickly and efficiently while maintaining high standards of quality and regulatory compliance.
Virtually walk through a KUBio™ facility with a FlexFactory™ platform
Services and support tailored for you
The services described above are only some of the solutions available to you. We also offer aseptic filling services, training and education, regulatory support, and more. All our support is customized for your needs.
FAQs
What differentiates Cytiva gene therapy manufacturing solutions?
We have solutions that cover every stage of development and manufacture, so you can receive end-to-end or targeted help.
How does automation improve gene therapy manufacturing?
Automating can increase your production efficiency and the quality and consistency of your drug.