ISPE Vision to Reality: Delivering Next Generation Therapies


This year’s theme for the ISPE 2018 Annual Meeting and EXPO is Vision to Reality: Delivering Next Generation Therapies.

One of the frequent challenges when delivering next generation therapies is available manufacturing space.  Either the existing facility is committed to current products with no excess capacity, or the time/cost to reconfigure the existing facility to meet the manufacturing conditions required by the new therapy doesn’t fit within the project budget/timeline.

To overcome these challenges, Biologics Modular (BM), one of Performance Validation’s partners offers a unique solution.  BM designs and manufactures GMP modular cleanroom facilities based on the intermodal container platform (i.e. shipping containers).  These modular units are designed to fit inside new or existing warehouse spaces. By retaining the corner blocks used by intermodal containers, BM cleanrooms, labs and clinics can be transported easily by truck, ship or train anywhere in the world. With these flexible, scalable, and transportable modular facilities, BM can guarantee a minimized capital cost and shortened production timeline (8-12 weeks) when compared to stick built construction.

About the DeployReady Platform:

Biologics Modular PPT 2018 – Bio Pharma Facilities by Julian Karras, VP Project Operations

 

In addition to adequate manufacturing space, another limitation is often the time and expense required to commission and qualify the manufacturing space.  Performance Validation has been retained by BM to assist in providing standardized deliverables to ensure quality, efficiency, and consistency in the commissioning and qualification effort from construction through delivery.  Performance Validation is located within 15 minutes of BM’s main construction/assembly facility ensuring efficient and timely availability of commissioning resources.  Commissioning provided by Performance Validation may include:

  • Commissioning Plan
  • User Requirements
  • Design Review
  • Commissioning /Qualification Documents
  • Execution
  • Test Problem Resolution
  • Summary Reports

Are you looking for a quick and economical solution to help bring your Vision to Reality?  Stop by Booth 817 to learn more about how Biologic Modular’s DeployReady Platform and Performance Validation’s integrated commissioning may be the right solution for you. Want to schedule a meeting? You may contact us via our Contact US form or email Rick Van Doel, Brad Henry, or John Underwood and we will be in touch shortly.