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IPS Technologies Tours

Biomanufacturing: Taking Technology to Production

With technical expertise spanning R&D to pilot-scale and large-scale production, our team knows the technology, trends and regulatory environment to successfully deliver your project. Our unique approach and technical expertise enables us to significantly improve operational capabilities, throughput and process control, optimize cost and minimize risk.

We have working experience with a wide range of products including vaccines, protein therapeutics, whole cell products, industrial enzymes, vitamins, organic acids, amino acids, DNA products and flu egg production.

  • Biologics Manufacturing
  • Large scale (>3,000L)
  • Multi-product, Multi-use
  • Biocontainment
  • Process Scale-up
  • Technology Transfer
  • Greenfield/Renovations
  • Single-Use Process
  • Modular Design
  • Conceptual Design Development
  • Cell Culture
  • Monoclonal Antibodies
  • Microbial Fermentation
  • Blood Products
  • Process Utilities
  • Vaccines
  • Process Modeling
  • FDA GMPs
  • International/ICH GMPS
  • Biosimilars
  • Process Validation

Several examples of successfully completed projects include Installation of Cell Culture Reactors; EPCMV for a 15,000sf Clinical Supplies Manufacturing/Filling Technology Upgrade; EPCMV for a 75,000sf Greenfield Manufacturing Facility for Cell Culture Bioproduction; Fast-track EPCM Modification of Existing Large Scale Cell Culture (LSCC) process systems;  Design, Engineering and Construction support for a Flu Adjuvant Manufacturing site; H1N1 Vaccine Manufacturer/Logistics Resource Planning and Scheduling to maximize efficiency and a Greenfield vaccine manufacturing facility using roller bottle technology.

For a recent client, we provided feasibility and engineering services to modify an existing large-scale CMO Stainless Steel (SS) facility to implement Single-use (SU) Technology and equipment-based processes. Our team of NextGen experts identified location options for new SU operations, including existing production space to a variety of warehouse, office and maintenance areas. To meet client short term, production and capital strategies, IPS adapted existing production areas for operating Single-use Bioreactors (SUBs) within GMP production areas. We also evaluated SU downstream processes and adapted to operate in a variety of configurations within current manufacturing spaces and optimized SU integration with “out-of-the-box” ideas and approaches. 

We partnered with our client on a 250,000sf Large-Scale Manufacturing Upgrade to increase titer capabilities and increase overall efficiencies with maximized throughput.  This project was awarded 2010 ISPE Facility of the Year Award for Operational Excellence.

Expert Insight