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.