Panacea Technologies and CXV Global are now Catalyx.
Read the press release and visit catalyx.ai to learn more.
About Us

Gene Therapy & CDMOs

The Gene Therapy and CDMO sector is a quickly growing and evolving market that requires an experienced and agile team. Panacea has been working heavily in the Pharmaceutical and Biotechnology industries for more than 25 years. Around five years ago, our existing clients began to pursue cell lines and treatments in the gene therapy space. Our team had extensive experience developing flexible and agile multi-product facilities and were asked to extend this to gene therapy processes that could be rearranged, scaled rapidly, and altered during trial manufacturing and testing.

 

This presented several challenges with data streams, reporting, and data availability across the greater data layer as there were more  stakeholders involved. We recognized the unique equipment demands that posed an integration and monitoring challenge as treatment manufacturing processes may change or receive alterations as the treatment scope expanded or focused on specific diseases or patient sectors. We drew on our previous Life Science experience and regulatory knowledge to develop project services that could better serve the development cycles and shifting timelines of that Gene Therapies required.

 

Industry references and word of mouth led us to Gene Therapy focused companies where we focused on:

  • Equipment selection
  • Creating an agnostic data layer to connect various equipment for a unified source of data for reporting
  • Role based reporting, alarming, and remote notifications
  • A visualization and control layer with controlled access based on stakeholder role
  • Building Automation
  • Environmental Monitoring
  • Utilities
  • Training for the end users on the delivered systems
  • Creating flexible and expandable systems as the scope, deployment dates, and suites often change during development

 

Our successful project delivery led to more projects and a honed set of project services unique to this industry sector. For a full list of project capabilities check out our Automation and Validation project services.

Panacea Technologies Benefits and Example Projects

We have provided some unique benefits Panacea holds in this sector as well as some representative projects below. For more information on our capabilities or to request project profiles and references please contact us.

Panacea Technologies Benefits

  • We have held an edge in this Industry because of our previous project experience and Innovation focus
  • Helping clients as they move cell lines and drug products through the different phases towards full scale manufacturing has helped us streamline the process to get there which has proved instrumental in helping gene therapy companies get from idea to patient in an effective, timely, and compliant manner
  • Our focus on innovation has allowed us to bring cutting edge but proven technologies and methods into a space that relies on it for progress
  • Gene therapy companies often like to have data available to everyone from the front-line scientist to the CEO, and we have been able to deliver that data, contextualized for the recipient, in many different forms including mobile
  • Our ability to tie together multiple different equipment and software platforms as well as various data lakes and databases into a cohesive data stream and workflow has led to a great deal of additional business by word of mouth
  • We provide IT services and lab equipment as well which has allowed us to sit at the table with automation, IT, scientists, and executive stakeholders and translate initiatives and goals to each group
  • Recently we have helped gene therapy companies expand into the CDMO space as well for additional revenue streams
  • We understand the agile team requirements during a project lifecycle as treatments are found to be effective for other diseases

Example Projects

  • Equipment selection, SOP authoring, Building Automation System, Environmental Monitoring System, Process Control System, Utilities, Electronic Batch Reporting, Reporting, Part 11 Gap Analysis, and Automation Network Design for a greenfield Gene Therapy site with multiple buildings utilizing a stacked suite deployment method
    • This scope included management and selection of electrical, mechanical, and calibration contactors
  • Design, configuration, deployment, validation, and qualification of a flexible gene therapy clinical suite within an existing manufacturing area for trials of an early stage gene therapy treatment
    • This scope included management and selection of electrical and calibration contractors
  • Equipment selection and design of the data layer including network design and deployment for a CDMO space within a Gene Therapy manufacturing site
    • This scope focused on providing separate access to external clients with validated data walls
  • Design, configuration, validation, and qualification of an Environmental Monitoring System for five new suites in a CDMO facility
  • Entire automation, validation, and Batch Management scope for a greenfield Gene Therapy site with the addition of a CDMO space
  • Design, configuration, validation, and qualification of the data layer including data historization, reporting, and remote alarming for an existing Gene Therapy site including utilities and Environmental Monitoring

Relevant Documents