5 ways cell and gene therapy programs can benefit from purpose-built technology
Cell and gene therapy programs face complex manufacturing challenges, and the tightening of regulations in the industry pushes the need for flexible and automated protocol adherence.
Many programs suffer from siloed, paper-based workflows, creating data fragmentation across collection, manufacturing, and treatment processes. This makes accepting changes for complex protocols challenging. Here are five ways your organization can benefit from the use of a technology solution built specifically to help you communicate across the supply chain and maintain a consistent approval rating among regulatory agencies.
Establish flexibility in protocol management
For organizations to effectively manage compliance standards for cell and gene therapies—commercially accepted or in a research & development phase—flexibility in your procedures is important. Successful change management occurs when your entire organization runs on a single technology platform, which allows you to share data seamlessly across your organization and with your partners.
Automate complex manufacturing processes
The increasing volume of cell therapy programs, trials, and protocols creates the need for variability in process. The ability to harmonize manufacturing workflows across your organization requires a system that can manage real-time process changes and communicate that across external stakeholders.
Optimize supply chain management
The typical process for cell and gene therapy products involves a collection site, manufacturing – either internal or a contract organization – and the clinical program treating the patient. Nearly every successful transplant represents programs and people coming together to create and deliver transformational care.
Software supporting these world-changing treatments must securely manage all entities involved in the chain while maintaining proper product management across equipment, people, materials, and other important resources involved leading up to and including treatment delivery.
Gain competitive insights through improved analytics
Different analytical methods can be used to assess critical quality attributes during development and manufacturing. These include measures such as identity, potency, purity, safety, and stability of the product. Methods used here can be complex and non-standardized. An effective software solution supports on-demand reporting and analytics, allowing stakeholders to use data to support manufacturing operations, research, and outcomes analysis.
Collaborate with the broader healthcare system
As the number of stakeholders involved in the development of cell and gene therapy products grows, your organization must be able to share data effectively with health systems, payers, pharmaceutical companies, accreditors, peer review panels, and more. You can collaborate with the broader healthcare system with an interoperable software solution.
The underlying platforms that enable the features and functions described in this guide must also be optimized for performance and usability. Many solutions may promise the same key features, but it’s important to investigate performance, configurability, and interoperability.
WellSky Biotherapies gives you a single data-management platform that flexes and supports the processes of every stakeholder in your supply chain. Work collaboratively with your partners leveraging the powers of interoperability, automated reporting, streamlined protocol management, and real-time visibility into the entire lifecycle of your clinical trials. From manufacturing, to delivery, to the lifetime follow-up procedures for your patients, WellSky Biotherapies powers your organization to scale the success of transformational medicine for your patients.