Biomanufacturing Engineering Services
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 any sized project. Our unique approach and technical expertise enables us to significantly improve operational capabilities, throughput and process control, optimize cost and minimize risk.
Bioprocess Expertise
- Cell Culture Process
- Flu Egg Vaccine Production
- Traditional / SU Technologies in Cell Culture
- Process Capacity Modeling / Simulation
- BL2+ / BL3 Facility Design
- Total Cost of Ownership Comparison
- Project Experience
BL2+/BL3 Facility Design
Since 1992, we have successfully completed vaccine and research facilities design for a variety of viruses, including:
- anthracis bacillus
- pneumonia / meningitus
- meningococcal A / C / Y / W
- varicella
- MMR
- papillomavirus
- staphylococcus aureus
- staphylococcus polysaccharide conjugate
- Influenza H5N1
- HIV
- small pox
IPS Biotech Experience
- 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
- Cell Culture Monoclonal Antibodies
- Microbial Fermentation
- Blood Products
- Process Utilities
- Vaccines
- Process Modeling
- FDA GMPs
- International / ICH GMPs
- Biosimilars
- Process Validation
Selected as partner for a $358MM contract for the development and operation of an Advanced Manufacturing Development (ADM) Facility for the US Department of Defense. The facility will conduct advanced development and manufacturing of Medical Counter Measures (MCM) that are FDA approved and ready for distribution to meet the needs of DoD for the foreseeable future.
New Greenfield 967,169sf design and validate a manufacturing campus for aseptic filling of live attenuated viruses, inactivated viruses and diluents in Brazil. Total volume production will double by 2018. Currently, it is one of the largest life science projects in the world.
Executed a fast-track project to modify multiple existing Large Scale Cell Culture (LSCC) process systems at a state-of-the-art, multi-product, biologics manufacturing facility. Technical content focused on addition of a CIP system and modifications to existing CIP systems to permit unlimited flexibility to use any CIP system to clean any unit operation, and to optimize the cleaning paths within each system to wring out every minute of idle time in these processes.
Modified existing large-scale CMO stainless steel facility to implement SU Technology and equipment-based processes. We identified location options for new SU operations, including existing production space to warehouse, office and maintenance areas. We adapted existing production areas for operating SU Bioreactors within GMP production areas. 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.