Projects

Selected list of executed projects.  Please contact us for further details of individual projects.

2008 – 2011

1) Validation of Biologics Pilot Plant

  • Complete validation project for a new cell culture pilot plant.
  • Development and update of Validation Master Plan, Scheduling, execution and close-out.
  • Subject Matter Expertise for design and design review of all sanitary process equipment and clean utilities
  • Review and execution of FATs for all sanitary process equipment

 

2) Antibiotic Facility Renovation

  • Conceptual design and Basis of Design for component and equipment preparation area
  • Development of equipment layouts, P&IDs, PFDs, equipment list and equipment datasheets.

 

3) New Bulk Vaccine Facility Expansion

  • Detailed design through SAT of a two 16 -Tank buffer preparation and hold suites.
  • Detailed design through construction of a bulk sterile filling skid.
  • Start-up, commissioning and troubleshooting of buffer prep/hold, microfiltration, chromatography and ultrafiltration skids.
  • Development of through-put data and cost estimation for sterile supply area washers, autoclaves and dry heat ovens.

 

4) Bulk Vaccine Facility Process Equipment Retrofit

  • Detailed Design support for existing and new equipment (datasheets, specifications, FAT, SAT, review and approval of 3D models)
  • Management of vendors (off site construction and on-site install) and management and execution FAT and SAT of process skids
  • Building-wide diaphragm valve replacement project

 

5) Bulk Vaccine Fill Facility (EU)

  • Detailed design through SAT for custom Process/Sonication/Filtration skid.

 

6) Phase 3 Vaccine Project

  • Conceptual design through support validation for a large-scale yeast fermentation and purification process (PFDs, P&IDs, data sheets, design summary and HAZOPs).

 

7) Bulk Vaccine Facilities – Process & Automation & Remediation

  • Conversion from existing Provox® platform to DeltaV® platform (control loops, recipes, and phases).
  • Equivalencies, data archiving and process quality.
  • Process validation, stability protocols and manufacturing document r-designs for recovery, purification and media/buffer steps).
  • Design and modification of process skids to comply with sterile/sanitary requirements.
  • Preparation and execution of FATs, SATs and IOPQ for improved manufacturing processes.
  • Troubleshooting, investigation of deviations and resolution of manufacturing problems.
  • Design and shakedown of CIP and SIP routs for the process skids.
  • Operating and troubleshooting software and hardware of DeltaV, unicorn, and AB-PLC systems.
  • Deviation management / investigating atypical process events and atypical.
  • Product impact assessments for sterile vaccine products.
  • Continuous process improvement and development of corrective and preventive steps.
  • Automation for a 51,000 square-foot GMP mammalian cell facility (DeltaV®, 10 equipment skids, and vial fill line).

 

8) Biologics R&D Pilot Plant Upgrade

  • FAT, start-up and commissioning and qualification of buffer distribution skid.
  • Determination of sterile boundaries for fermentation equipment.
  • Update of CIP PLC and HIM programming, testing and documentation.

 

9) Biologics Contract Manufacturer

  • Detailed engineering for modification of bioreactor vent systems including selection of all components.

 

2006 – 2008

10) Biologics and Pharmaceutical R&D Facility

  • Development of Validation Master Plan.
  • Investigation and troubleshooting of OOS reports.
  • Start-up/Troubleshooting and Validation of process equipment (bioreactor, fermentor, CIP skid, high purity water system, clean steam system and lab equipment).

 

11) Bulk Vaccine Facility Upgrades

  • Submittals review and approval (P&IDs, general arrangements, datasheets, and specifications) of a sterile adjuvant system.
  • FATs, installation, start-up, troubleshooting and commissioning.
  • Commissioning master plan, test plans, execution and validation support.
  • Remediation of a buffer prep and buffer hold equipment (equipment P&ID’s recommended new CIP/SIP flowpaths).

 

12) Biologics R&D Pilot Lab

  • Development of CIP, SIP, and Product Transfer flow paths and valve sequencing.
  • Management of devicenet system, teledata/ethernet, electrical/UPS, PCS implementation (reporting, security, HMI installation/continuity, flow path/circuit implementation and integration with vendors systems).
  • Commissioning of autoclaves and parts washers.

 

13) New Bulk Vaccine Facility Expansion

  • Design documentation, model development, management of vendor install of equipment, FAT and SAT for buffer Prep/hold skids, micro/ultra-filtration and chromatography.
  • Development of through put data and cost estimates for sterile supplies equipment (washers, autoclaves and dry heat ovens).
  • Model reviews.
  • Operating and troubleshooting software and hardware of DeltaV, Unicorn, and AB-PLC system.

 

14) Biologics Bulk Contract Manufacturer

  • Equipment/facility solutions for process equipment Change Control, equipment electrical modifications, PM scheduling, utility modifications, facility shutdowns, and other associated tasks.

 

 

15) Biologics Bulk Filling Contractor

  • Process development for new sterile blow fill seal products.
  • Design and execution of feasibility & engineering studies and development of batch records for new processes.
  • Development of sterility assurance validation master plans authoring of summary reports.
  • Deviation investigation & authoring deviation reports.

 

 

2002 – 2006

16) Bulk vaccine facilities – process sciences

  • Improvement of Media Challenge Process and vaccine production processes
  • Performance of lab scale studies (raw materials approvals from new vendor, piping materials compatibility study and valve leak tests.

 

17) Process Engineering Support Services

  • Consulting services for pressure relief design and use of pressure vessels and equipment.
  • Evaluated process safety by assuring structural integrity of the components, regulation of

 

 

18) Bulk cell culture drug facility (EU & Peurto Rico)

  • Provide consulting process engineering expertise to on cell culture media process and WFI system project.

 

 

19) Biologics R&D Pilot Plant A, B and C

  • Design, BOD development, start-up and commissioning.
  • Specification and quotation review for all equipment, design review of all equipment and utilities, project/personnel scheduling, small equipment procurement, FAT coordination, commissioning test plan development and execution.
  • Execution of FAT for automated filtration skids, process vessels, autoclaves and laminar flow hoods.
  • Start-up, troubleshooting, commissioning and validation support for bioreactors, buffer storage containers, autoclaves, parts washer, media/buffer skids, custom blast freezer, disposable bioreactors, waste water reclamation system, USP water system and clean steam generator and distribution system.
  • Development and execution of start-up and commissioning and load patterns for parts washer and autoclave.
  • Reviewed automation and controls designs (URS/FRS/DDS).
  • Engineering support for construction punch-list, equipment changes, PFD reviews, equipment layouts proofs, SOPs, PM plans and P&ID and GA redlines for as-builts.

 

20) Bulk Biologics Facility A

  • Design support for all process equipment and process utilities including 2,12,500L bioreactors and bulk shipping containers.
  • Start-up, troubleshooting and commissioning of production scale bioreactors, CIP, MF/UF systems and LC systems and ultra filtration systems.
  • Troubleshooting automation integration issues.
  • Commissioning and validation support for WFI, RO, glycol, biowaste, waste neutralization, CIP systems, chillers, re-heat coils, boilers, plant steam, clean steam systems and Siemens BMS.

 

21) GMP Fermentation Plant

  • Equipment/facility solutions for process equipment change control, equipment electrical modifications, PM scheduling, utility modifications, facility shutdowns and associated tasks.
  • Created system to control the process equipment spare parts inventory.
  • Provided real-time remediation for equipment breakdowns during GMP processing.
  • FAT, start-up, commissioning and troubleshooting and validation support for custom automated chromatography skid, MF/UF Skid, large-scale chromatography columns, column packing skid and continuous centrifuge.

 

22) Bulk Biologics Facility B

  • Development of URS/FRS/DDS for automated process chromatography skids, packing skid, and MF/UF skids.
  • Design reviews (BOD, equipment list, layouts, P&IDs, PFDs and GAs) for chromatography systems, MF/UF systems and portable vessels.
  • Design review for multiple projects with prototype bioreactor, product hold vessels, depth filtration skid, support utilities, and facility layout.
  • HAZOP review for both upstream and downstream equipment.
  • Development of Sterilization Out of Place (SOP) Cycle for alternating tangential flow filters and depth filter housings.
  • Design review, FAT, commissioning and start-up support for upstream purification equipment (product hold vessels, CIP skid, HWFI skid, temperature control modules and utility expansion of clean steam, clean air, plant steam, and chilled water).
  • FAT, start-up, commissioning, troubleshooting and validation support for GMP autoclave.

 

 

23) Bulk Cell Culture Drug Facility (EU)

  • Lead engineering function from the conceptual design phase through detailed design of a 100MM cell culture manufacturing facility expansion and utilities upgrade.
  • Design review and design development (PFDs, P&IDs and URSes) for all new process equipment skids (e.g. bioreactors, chromatography systems, UF/DF system and CIP skid).

 

 

24) Contract Fermentation and Cell Culture Manufacturer

  • Specification and procurement of fermentor and cell culture equipment including re-folding tank and large-scale disc-stack centrifuge.
  • Manufacturing process transfer for commercial production of bulk drug product.
  • Design and implementation of fermentation feed and control strategy at large-scale including characterization of kLa, tip speeds, mixing times and response times.
  • Development of process parameters for recovery steps (liquid-liquid extraction, refolding, liquid – liquid separation, filtration and clarification via TFF/centrifugation).

 

25) GMP Oligonucleotide Facility

  • Automation, documentation and validation for of DeltaV controls.
  • Vendor source code and IT compliance audits.

 

Prior to 2002

26) Biologics R&D Pilot Plant A

  • FAT, start-up, CIP/SIP development and validation support for multiple bioreactors, fermentors, chromatography skids, cell homogenizer, process vessels, CIP systems, TFF skids, depth filters, autoclaves and dry heat ovens.
  • Start-up and management of lab equipment (e.g. laminar flow hood, balances, stir plates, pumps, centrifuges, water baths, sterile tubing welders, spectrophotometers, refractometers, and filter integrity testers).
  • Development of SOPs (operation, CIP/SIP) and PM plans for all process equipment.
  • Preparation of VMP and execution of IOPQ protocols for software, utilities, and processing equipment
  • Construction completion oversight for processing suites
  • Preparation and execution of batch process documentation for engineering and cGMP batches of fermentation, cell culture and purification lots.
  • Execution of mixing experiments in bioreactors, PID loop tuning for DO and pH control.
  • Modification of skid automation under change control.

 

27) Biologics R&D Pilot Plant B

  • Pilot Plant bioreactor engineering studies (CIP/SIP/Operability and aseptic transfers).

 

28) Bulk cell culture drug facility

  • Laboratory autoclave engineering study (suitability for validation) and valve and filter housing SIP studies.

 

 

29) GMP Fermentation Plant

  • Troubleshooting and commissioning for production scale fermentor and associated process equipment.

 

 

30) Bulk Vaccine (Fermentation) Drug Facility

  • Vaccine manufacturing facility start-up, IQ/OQ and CIP/SIP cycle development and validation.
  • Manufacturing process shake-down, batch record development and clinical manufacturing support.
  • PLA preparation, operator training, SOP development, change control.

 

 

31) Biologics Start-Up Company

  • Detailed P&ID reviews for sterile processing equipment, CIP and SIP.
  • Review and approval of Fermentation and Purification PFDs and Pilot plant production metrics.
  • Screening, due diligence and selection of a contract bio-manufacturing facility for lead drug candidate (Phase i).

 

 

32) Barrier Isolation Vial Filling Line

  • Computer system validation for a locally controlled Environment (LCE).
  • Development of test protocols for SCADA and PLC
  • SOP development and field testing and troubleshooting

 

 

33) Bulk Biologics Facility A

  • Development and execution of FAT and IOQ for 8,500L buffer tanks, chromatography skids, MF/UF systems, and CIP skids.

 

 

34) Biological Sample Storage and Testing Facility

  • Development and execution of validation (IOPQ) for controlled temperature units, terminal HEPA Filters and Biosafety cabinets.

 

 

35) Biologics R&D Pilot Plant C

  • Development of PM procedures for all process equipment (incubators, bioreactors, MF/UF skids, parts washer, autoclave, CIP skid, lab equipment and process support equipment.

 

 

36) Biochemical R&D Pilot Plant

  • Modification and maintenance of fermentor code for operation, CIP and SIP.
  • Support for Migration of a Provox DCS to a DeltaV system.

 

 

37) Biologics Start-Up Company

  • Production, troubleshooting and engineering support for MAb production with CHO, Hybridoma and E. coli cultures.
  • Scaled-up from bench to 200L bioreactors and harvest via TFF.
  • Technology transfer to pilot plant and manufacturing facility.

 

 

38) Bulk Biologics Facility A

  • Design, and implementation of modifications to a chilled water system.
  • Engineering and installation of a Purified Water System.

 

 

39) Animal Growth Hormone Facility

  • FAT, SAT, commissioning and testing of Provox system for fermentation, isolation, purification, lyophilization, formulation, syringe filling and packaging.
  • Developed of DDS, SOPs and Change Control Procedure.
  • Supported AspenTech data historian and electronic batch report system.
  • Development and execution of validation protocols for automation and process equipment.