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

Pharmaceutical & Biotechnology

Panacea’s first project was in the Pharmaceutical Industry, and from that project sprung the robust set of standards we still utilize today. With more than 25 years of experience in the Pharmaceutical and Biotechnology industries we have developed a complete set of project services that touch almost every area within a modern Life Sciences organization. We have executed several hundred major projects in this sector including one of the largest Biotech facilities in the world. We are experts in GxP processes and offer validation services in conjunction with our project service. We also have expertise in Part 11/Annex 11 Gap Analysis and Remediation/Validation.

 

Our project services cover the complete manufacturing process focusing on upstream and downstream processing with similar services for lab groups, Research and Development organizations, utilities, Building Automation, Environmentally Monitoring, and fill/finish. We also work extensively in data historization, reporting, and IIoT applications. Our entire engineering group is trained in the Life Sciences Industry not just on automation and regulatory practices, but also on the biological processes behind cell culture and drug manufacturing. This knowledge has allowed us to work across the different groups in a Pharma/Biotech organization creating effective projects that show an understanding of the underlying science.

 

We pride ourselves on innovation and work to deliver technologies that provide our clients with a competitive edge in bringing new therapies to market, extending the lifecycle of aging infrastructures, and improving existing processes with efficiency increases and decreases in operating and training costs. We spend a significant amount of time researching Industry trends and working to help our clients understand and implement projects in response to regulatory trends and guidance.

 

For a detailed list of project services check out our Automation and Validation information pages. Do you have an aging infrastructure? Check out our Modernization & Migration project services.

Example Projects

We have provided some representative projects below. For more information, references, or a detailed overview of our offering contact us today.

  • Design, Configuration, and Validation of one of the largest multi-product Biotech facilities in the world with a scope of work that included upstream, downstream, utilities, data historization and reporting, and batch management
  • Migration under change control of the SCADA layer for a multi-product facility producing $6B USD of product per year
  • Alarm rationalization for an entire campus including implementation of a new remote alarm and notification system
  • Deployment of a sitewide data historian and reporting platform including validation and OPC layer deployment
  • Automation Network design and deployment for a greenfield manufacturing and R&D site
  • Legacy Install Base evaluation and Modernization plan creation and execution over three years for a major multi-product manufacturing campus
  • ELN deployment and integration
  • Process Mapping and Integration for a new MES deployment
  • Automation and Validation Master Plan creation
  • Deployment and integration of more than ~80 bioreactors with a Batch Manager and Electronic Batch Reporting
  • Utilities Expansion including design, configuration, and validation of new WFI stills, CIP, SIP, and Batch Manager integration
  • Greenfield facility deployment with complete Process Control System (PCS), BAS/EMS, Utilities, and Plant Floor Network scopes including hardware deployment, validation, and management of all sub-contractors

Relevant Documents