Service Examples

Biologics and Vaccine Facilities

Equipment/Project

• Conceptual design through C & Q support (PFDs, Data Sheets, Design Summary and IOQ) for a large-scale yeast fermentation and purification process.
• Detailed design reviews (Datasheets, Specifications, FAT, SAT, review and approval of 3D Models) for a yeast based vaccine facility.
• Design review and design development (PFDs and URSes) for all new process equipment skids (e.g. bioreactors, chromatography systems, UF/DF system and CIP skid) for a Mab facilty.
• Design reviews (BOD, equipment list, layouts, PFDs and GAs) for chromatography systems, MF/UF systems and portable vessels, prototype bioreactor, product hold vessels, depth filtration skid, support utilities and facility layout for a cell culture facility.
• Design documentation, model development, management of vendor install of equipment, FAT and SAT for Buffer Prep/Hold Skids, Micro/Ultra-filtration and Chromatography for cell culture
• 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).
• Design support for all process equipment and process utilities including multiple 12,500L bioreactors and bulk shipping containers for biologics facility.
• Conceptual design through SAT for Buffer Tank Preparation and Hold suites for a Mab facility.
• Detailed design through SAT for custom Process/Sonication/Filtration skid and bulk Sterile-Filling Skid.
• Reviews for both upstream and downstream equipment for Mab facility.
• Project Management function from the conceptual design phase through detailed design of a 100MM cell culture manufacturing facility expansion and utilities upgrade.
• Management of vendors (off site construction and on-site install) and management and execution FAT and SAT of process skids for cell culture facility.
• Specification and procurement support of fermentor and cell culture equipment including re-folding tank and large-scale disc-stack centrifuge for bacterial process facility.
• Submittals review and approval (P&IDs, General Arrangements, Datasheets, and Specifications) for a Sterile Adjuvant System.
• Process consulting services for Cell Culture Media process and WFI System project.

Automation/Controls

• Automation support for a 51,000 square-foot GMP mammalian cell facility (DeltaV®, 10 equipment skids, and Vial Fill Line).
• Operating and troubleshooting software, hardware and integration issues between DeltaV, Unicorn, and AB-PLC systems.
• Development of URS/FRS/DDS for automated process chromatography skids, packing skid and MF/UF skids.
• Conversion from legacy Provox® platform to DeltaV® platform (control loops, recipes, phases, equivalencies, data archiving and process quality).
• Design and implementation of fermentation feed and control strategy at large-scale including characterization of kLa, tip speeds, mixing times and response times.

C & Q

• Commissioning Master Plan, Test Plans, execution and validation support for many vaccine facilities.
• Commissioning and validation support for WFI, RO/DI, glycol, biowaste, waste neutralization, CIP systems, chillers, re-heat coils, boilers, plant steam, clean steam systems and Siemens BMS for a complete facility.
• Start-up, troubleshooting and commissioning of production scale bioreactors, CIP, and MF/UF systems and LC systems for Mab facility.
• FAT, start-up, commissioning, troubleshooting and validation support for GMP autoclave for biologics facility.
• Start-up, commissioning and troubleshooting of Buffer prep/hold, Microfiltration, Chromatography and Ultrafiltration skids for vaccine facility.
• Vaccine manufacturing facility start-up, CIP/SIP cycle development and validation (IOPQ).
• Preparation and execution of FATs, SATs and IOPQ for improved manufacturing processes for vaccine processes.
• Development of Sterility Assurance Validation Master Plan. and authoring of summary reports.

Process/CIP/SIP

• Performance of lab scale studies (raw materials approvals from new vendor, piping materials compatibility study and valve leak tests).
• Building-wide diaphragm valve replacement project.
• Laboratory autoclave study (suitability for validation) and valve and filter housing SIP studies.
• Development of through-put data and cost estimates for Sterile Supplies equipment (washers, autoclaves and dry heat ovens).
• Development of Steam-out-of place cycle for alternating Tangential Flow Filters and depth filter housings.
• Process model reviews.
• Design and shakedown of CIP and SIP routes for process skids.
• Remediation of a buffer prep and buffer hold equipment (P&ID’s and recommendation of modified CIP/SIP flowpaths).
• Equipment/facility solutions for process equipment Change Control, equipment electrical modifications, PM scheduling, utility modifications, facility shutdowns, and other associated tasks.
• Process development for new Sterile Blow Fill Seal products.
• Manufacturing process transfer for commercial production of bulk drug product.
• Development of process parameters for recovery steps (liquid-liquid extraction, refolding, liquid – liquid separation, filtration and clarification via TFF/centrifugation).
• Troubleshooting and commissioning for production scale fermentor and associated process equipment.

Quality/Quality Systems

• PLA preparation, operator training, SOP development and change controls.
• Deviation Management/investigation of Atypical Process Events.Troubleshooting. of deviations and resolution of manufacturing problems.
• Design and execution of feasibility studies and development of Batch Records for new manufacturing processes.
• Process Validation, Stability Protocols and Batch Record re-design for recovery, purification and media/buffer steps.
• Product Impact Assessments for sterile vaccine products.
• Continuous Process Improvement & Development of CAPA
• Design and modification of process skids to comply with sterile/sanitary requirements.
• Improvement of Media Challenge Process and vaccine production processes.

Contract Biologics Manufacturers

• 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).
• Project Management and installation oversight for modification of bioreactor vent system.

Biologics Start-Ups

• Screening, due dliligence and selection of contract sites for lead drug product candidates.
• Production, troubleshooting and floor support for MAb production with CHO, Hybridoma and E. coli cultures.
• Detailed reviews for sterile processing equipment, CIP and SIP
• Review and approval of Fermentation and Purification PFDs and Pilot plant production metrics.
• Scale-up from bench to 200L bioreactors and harvest via TFF.
• Technology transfer suitability to pilot plant and manufacturing facility.

Cell Therapy Projects

• Complete oversight for design development, fabrication and testing of large voume perfusion systems, bag filling equipment and bulk drug formuation.
• Review of cell cryo-freezing processes using mechanical and LN2 freezers

Barrier Isolation Vial Filling Line

• Computer system qualification support for a Locally Controlled Environment.
• Development of test protocols for SCADA and PLC.
• SOP development and field testing and troubleshooting.
• Start-up and commissioing support.

Biological Sample Storage and Testing Facility

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

Animal Growth Hormone Facility

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

Bulk Antibiotic Facilities Renovation

• Development of equipment layouts, PFDs, equipment list and equipment datasheets.