Biopharm Project Solutions
BioPharm Project Solutions (BPS) specializes in providing professional services, process engineering, project management, and consultancy for the biopharmaceutical and biologics industry. With extensive experience in biologics processes, equipment, and facility design, BPS aims to support clients from concept through licensure, ensuring efficient, compliant, and optimized manufacturing operations.
Industries
Nr. of Employees
small (1-50)
Products
Commissioning & Qualification
Provides start-up, commissioning, and qualification services for biologics production facilities, including developing plans, coordinating QA activities, and executing protocols.
Process and Project Review
Offers conceptual and detailed design reviews, scope development, process descriptions, and automation/mechanical/process overlap evaluations for biologics projects.
Manufacturing Process Science and Technology
Supports development and optimization of biologics manufacturing processes, including fermentation, cell culture, recovery/harvest, purification, and bulk formulation.
Project Planning and Management
Manages biologics projects from clinical development through post-IOQ stages, coordinating between clients, engineers, fabricators, and other stakeholders.
Manufacturing Operations Support
Provides on-the-floor and in-the-lab support for biologics manufacturing, including optimization, troubleshooting, SOP development, and addressing CAPAs.
Consultancy
Offers consulting services for process modeling, simulation, optimization, GMP audits, technology platform conversions, and materials re-use.
Commissioning & Qualification
Provides start-up, commissioning, and qualification services for biologics production facilities, including developing plans, coordinating QA activities, and executing protocols.
Process and Project Review
Offers conceptual and detailed design reviews, scope development, process descriptions, and automation/mechanical/process overlap evaluations for biologics projects.
Manufacturing Process Science and Technology
Supports development and optimization of biologics manufacturing processes, including fermentation, cell culture, recovery/harvest, purification, and bulk formulation.
Project Planning and Management
Manages biologics projects from clinical development through post-IOQ stages, coordinating between clients, engineers, fabricators, and other stakeholders.
Manufacturing Operations Support
Provides on-the-floor and in-the-lab support for biologics manufacturing, including optimization, troubleshooting, SOP development, and addressing CAPAs.
Consultancy
Offers consulting services for process modeling, simulation, optimization, GMP audits, technology platform conversions, and materials re-use.
Services
Services covering basis of design, process descriptions, PFDs, P&IDs, equipment specifications and bid packages for expansions, modifications or new biologics facilities.
Development and execution of commissioning plans, FAT/SAT, IQ/OQ/PQ/DQ protocols, IOPQ testing and final qualification reporting to support facility start-up.
Automation strategy, URS/FRS/DDS development, control implementation, migration support and troubleshooting for PLC/SCADA/DCS systems and process skids.
Root cause analysis and remediation for CIP/SIP failures, sterilization issues, contamination/bioburden events, filtration and chromatography performance, and process deviations.
Assessment and selection of tubing sets, bags, filters and disposable purification components; development of single-use integration strategies and qualification of third‑party suppliers.
Assessment of maintenance programs, calibration, PM scheduling, equipment retrofits/upgrades, utilities remediation and HAZOP/root cause analysis support.
Services covering basis of design, process descriptions, PFDs, P&IDs, equipment specifications and bid packages for expansions, modifications or new biologics facilities.
Development and execution of commissioning plans, FAT/SAT, IQ/OQ/PQ/DQ protocols, IOPQ testing and final qualification reporting to support facility start-up.
Automation strategy, URS/FRS/DDS development, control implementation, migration support and troubleshooting for PLC/SCADA/DCS systems and process skids.
Root cause analysis and remediation for CIP/SIP failures, sterilization issues, contamination/bioburden events, filtration and chromatography performance, and process deviations.
Assessment and selection of tubing sets, bags, filters and disposable purification components; development of single-use integration strategies and qualification of third‑party suppliers.
Assessment of maintenance programs, calibration, PM scheduling, equipment retrofits/upgrades, utilities remediation and HAZOP/root cause analysis support.
Expertise Areas
- Process engineering for biologics
- Bioprocess scale-up and technology transfer
- GMP commissioning and qualification
- Single-use and disposable systems integration
Key Technologies
- Stainless-steel and single-use bioreactors
- Tangential flow filtration (TFF)
- Depth filtration
- Disc-stack centrifuges