Cell Therapy Microbiology Consulting, LLC
President and Principal Consultant | July 2013 – Present
- Independent consulting services primarily designed for the unique microbiology and contamination control challenges in the cell and tissue therapy sectors, regenerative medicine, and biopharmaceutical industries.
- Biologics Consulting Group, Inc., Alexandria, VA: (2023-present). Worked as an Affiliate with Biologics Consulting Group for PolarityTE, Salt Lake City, UT. Writing microbiology SOPs, wrote EM site risk assessment, routine EM sampling program, and EM sampling methods including, viable and non-viable sampling, gowning qualification, personnel monitoring for skin tissue-based manufacturing.
- Celularity, Inc., Florham Park, NJ: (2022-2023). Disinfectant efficacy study review and gap analysis of executed coupon study and recommendations. Justification of alert / actions levels, EM program risk assessment for sample site justification and monitoring frequency, and justification for the reduction of routine and in-process EM samples.
- Theragent, Inc., Arcadia, CA: (2022-2023). Consulting on microbiological technical and scientific procedures and processes related to cell/gene therapy microbial control in cGMP Manufacturing setting. Including production and testing of activities in the manufacturing clean rooms as well as critical reagents, product intermediates and final products used in clinical trials.
- Crispr Therapeutics, Inc., Framingham, MA: (2021-2022). Development of EM and utility monitoring programs customized for Crispr facility. Specifically, EM risk assessment, utility monitoring program (e.g., CO2, CCA, and other compressed gas), sample site selection and justification, SOPs for routine and in-process EM, personnel monitoring, alert/action investigation and response, LIMS trending and reporting, and gowning qualification procedures. Review of facility cleaning plans, disinfectant agents, frequency, and scope based on area classification and develop disinfectant efficacy project plan.
- Iovance Biotherapeutics, Inc. Philadelphia, PA: (2019-2021). Authoring and review of microbiological programs, procedures, and associated testing including EM and clean room certifications, microbiological SOPs, and disinfectant qualification strategies. Aseptic gowning risk assessment for reusable garments, technical review of PCR mycoplasma results from CMOs and mycoplasma OOS unexpected PCR results.
- Tessa Therapeutics, Singapore: (2020). Prepared EM strategy and HACCP based risk assessment report to establish qualification EM sampling plans for the Tessa cell processing facility and QC laboratory for all Grades A, B, C, D.
- NK Max America, Santa Ana, CA: (2019-2020). Evaluated manufacturing facility microbiological contamination controls and in-process sterility and final product safety release testing. Developed EM risk assessment sampling plan, SOPs, cleaning / sanitization program including agents, materials, application, and efficacy qualification.
- Rubius Therapeutics, Inc., Cambridge, MA: (2019). Reviewed validation reports and IND sections for product sterility and consulting related to the BacT/Alert® method qualification and suitability. Authored sections in regulatory submissions to justify sole use of the BacT / Alert® 3D system for drug product sterility testing to replace USP 〈71〉.
- Discgenics, Inc. Salt Lake City, UT: (2018-2019). Review proposed cell therapy facility layout with estimates for QC Micro lab design, space allocation, and benchmarking with best industry practices and cGMPs. Generating risk assessment emphasizing aseptic processing, contamination controls, and EM for all Grades A – D. Specifically, product, materials, samples, and personnel flows; pressure differentials; appropriate Grades (at-rest, operational); BSC locations; risk-based EM sites for in-process and final fill/finish Grades A and B.
- Sigilon Therapeutics, Cambridge, MA: (2019). Review of pre-clinical cell therapy EM data and results per relevant industry guidance to assess for gaps. Provided recommendations on EM trend report format, data presentation, statistical analysis where applicable, and reporting structures, (e.g. charts, graphs, tables).
- Fate Therapeutics, San Diego, CA: (2018-2019). Provided training modules for manufacturing staff, covering aseptic techniques, working in BSCs and aseptic processing principles including, gowning, cleanroom behavior, and basic microbiology. Review new cell therapy manufacturing cleanrooms and report covering usage of these areas including, personnel, material, sample and waste flows; classifications; equipment and BSC locations; gowning; EM and PM; cleaning and sanitization agents, frequencies, flows, and sanitizing / disinfecting materials for entry into clean rooms and BSCs; appropriate segregation for multi-product and multi-donor concurrent operations; required start-up and qualification activities.
- WuXi AppTec, Inc. Philadelphia, PA: (2019). Review proposed architectural diagrams of cell therapy microbiology laboratory space and sterility testing area to ensure the design is fit for intended purpose.
- Gradalis, Inc. Carrollton, TX: (2018-2020). Provide risk-based approach for a new EM site plan program for a solid tumor cell processing facility. Developed an EM master plan that was executed for the design and performance of facility EMPQ. Developed pre-determined responses to EM excursions or environmental control failures. Developed a BacT/Alert® test method validation protocol as alternate test to USP 〈71〉 to accomplish reduced time from 14-days to potentially 7-days or less.
- Juno Therapeutics (Bristol Myers Squibb Co.), Inc. Seattle, WA: (2017-2018) Provided the design and development of documentation for rapid sterility method validation (Milliflex-Rapid, BacT/Alert®). Providing EM and microbiology expertise in support of BLA filing and readiness for pre-approval inspection. Consultation on validation of rapid Mycoplasma testing by PCR.
- Tessa Therapeutics, Singapore: (2017) Worked with HH Consulting, LLC to provide due diligence assessment on behalf of Temasek Holdings. Reviewed microbiological-related aspects of Tessa Therapeutics’ CMC for proposed commercial cell therapy manufacturing facility. Determined standards of quality, identified gaps in processes and protocols, with recommendations on how to address these gaps.
- Bluebird Bio, Cambridge, MA: (2017) Assisting in the development and execution of rapid sterility testing for company’s cell therapy product platforms.
- Argos Therapeutics, Durham, NC: (2017) Provided microbiology support for rapid sterility test validation by contract cell therapy manufacturer. Review and comment on company’s rapid safety test regulatory filing including PCR Mycoplasma and rapid sterility.
- bioMerieux Corporation, Durham, NC: (2017) Providing a paper intended for publication discussing the validation of rapid alternate sterility testing methods of cellular therapy products. Paper to address several aspects including: regulatory requirements and expectations, considerations for test sample volumes, selection of challenge organisms, laboratory resource requirements and constraints (in-house vs. contract lab), estimates for Return on Investments (ROI), considerations for 361 vs. 351 cGMP cell products, and phase of product development whether in Phase 1, 2, 3, or commercially licensed cell products.
- Atara Biotherapeutics, Westlake Village, CA: (2016−2017) Review of GMP product manufacturing processes, with an emphasis on (a) microbiological design aspects of a planned CTL manufacturing facility, including lab design and benchmarking on best industry practices for microbiology methods and GMP compliance; and (b) development and review of microbiology QC SOPs and methods including rapid sterility in-house.
- Cognate Bioservices, Memphis, TN: (2016−2017) Evaluated the Company’s EM policies and practices and provided EM risk assessment reports for existing as well as newly constructed aseptic cell processing areas. Assessments included personnel monitoring practices; material transfer / bioburden reduction policies; and EM trending. Revised the Company’s SOPs for EM of Aseptic Processing Areas, including the build out of the Company’s Memphis facility with an emphasis on baseline routine EM in anticipation of PAI and commercial readiness. Designed EM trending spreadsheet templates for trending of routine and personnel EM. Reviewed and revised Company’s cleaning and sanitization program and assisting in disinfectant efficacy qualification.
- Kite Pharma, Inc. Santa Monica, CA: (2015). Provided microbiological risk review of CAR-T manufacturing process with recommendations on closing open process steps on batch records where feasible. Performed training sessions on aseptic processing for operators. Review and provided recommendations on product microbial testing methods. Contamination control recommendations on clinical/commercial facilities.
- Progenitor Cell Therapy (PCT Caladrius), Allendale, NJ: (2015) Evaluated companies EM and Microbiology product and safety testing programs at multiple facilities. Performed gap and risk analysis, provided recommendations to harmonize systems from site to site.
- National Institutes of Health, Department of Transfusion Medicine (DTM), Bethesda, MD: (2016) Reviewed microbiology programs and developed recommendations for multi-facility EM including assessments for number & locations of EM sites, sampling frequencies, and justify site-specific alert and action levels. Assessed cGTPs / cGMPs against regulatory and accreditation standards. Reviewed aseptic / sterile processing practices, cleaning, and gowning procedures. Provided written comprehensive SWOT report with clear and supported recommendations.
- Webinar presentations: EM for Cell Therapy Products, Validation of Alternate Sterility Tests for HCT/Ps, Cleaning, Sanitization, and Qualification of Disinfectant Efficacy for Cell Therapy Products.
LEXAMED LTD – Toledo, OH (2014 – 2016)
Sub-contracted work under LexaMed Ltd. Work covered services related to aseptic processing and microbiology for various manufacturing firms including aseptic filling, compounding, and radiopharmaceuticals.
- QuVa Pharma, Sugar Land TX: (2016) Created an aseptic process simulation master plan document to support sterile compounding manufacturing operations at QuVa Pharma 503B facilities.
- Fresenius-Kabi, Buffalo, NY: (2016) Provided EM risk assessment and EM site selection report for new aseptic processing Isolator filling lines.
- Cardinal Health, Dublin OH: (2014) Reviewed and revised the aseptic process media fill program applicable to 36 U.S. Cardinal Health PET (Positron Emission Topography) manufacturing sites. Defined and revised the Operator Qualification and Manufacturing Site Qualification SOPs and Batch Records for process simulation media fills.
- Par Pharmaceuticals, Rochester, MI: (2014) Comprehensive evaluation of the aseptic filling environmental and personnel monitoring programs at the Rochester 171,000 sq. ft. production facility. Provided well-received written comprehensive report with clear and supported recommendations.
Dendreon Corporation, Seattle, WA
Sr. Scientist II, Corporate Microbiology | December 1999 – June 2013
Responsible for the development of microbiological policies, ongoing multi-site support, and the design, implementation, and harmonization of the environmental monitoring (EM) programs at all Dendreon commercial cell therapy processing facilities. Developed and validated the PROVENGE cell therapy product microbiological testing programs currently utilized at all commercial facilities. Part of this included the project to replace the traditional sterility test method per the former biologics regulation 21 CFR 610.12 with an alternate rapid method platform utilizing the growth-based BacT/ALERT system. The BacT/ALERT method decreased test time fron 14 days to a 7-day test with a 36-44 hour in-process pre-harvest negative-to-date release for administration. Developed the project design, performed feasibility/proof-of-concept testing, wrote the validation protocols, sterility test methodology, and performed the method validation and performance qualification of the BacT/ALERT system. The alternate method ultimately gained FDA approval for use in the U.S. during Phase III trials and subsequently for commercial distributed product. Lead the cross-site microbiology management team to identify and implement continuous microbiology improvement projects, EM efficiencies, and implemented change control improvements to meet cGMP. Created microbial investigation procedures, and performed sterility failure OOS and EM investigations. Developed the aseptic processing, basic microbiology, gowning and cleanroom behavior training presentations for Quality and cell process Manufacturing staff. Technical lead in the development of an automated microbiological Gram stain and rapid endotoxin testing methods to reduce labor, test turnaround time, and cost-of-goods (COGS). Designed the microbiology method and technology transfer to U.S. satellite sites and European CMO. Participated as subject matter expert in multiple FDA and other regulatory inspections at multiple manufacturing facilities. Authored numerous microbiology technical reports, position papers, and validation protocols and reports. Have given several talks (e.g. ISCT, PDA, AABB symposiums) concerning development and validation of alternate sterility testing rapid microbiology method using the by BacT/ALERT system.
Quality Control Supervisor
Provided training and supervision of laboratory analysts in testing methods, pharmaceutical water and EM programs, product testing, endotoxin LAL method, microbial identifications, data review and approval, setting goals and project timelines. Functioned as the central EM program coordinator for multiple satellite cell therapy CMO sites including Progenitor Cell Therapy (PCT), Hackensack NJ and Mountain View CA; Mayo Clinic, Rochester MN; and American Red Cross, Philadelphia PA. These responsibilities included the development of site EM plans and EM site selections, executing and overseeing clean room performance qualifications, and creating and reviewing periodic trending reports for the cellular therapy processing laboratories. This also included training the satellite CMO manufacturing and quality staff in the implementation of aseptic gowning and new gown qualification program. Wrote microbiology portions of the Biological License Application for PROVENGE consisting of microbiological product attributes, contamination controls, disinfectant efficacy, and environmental controls. Member of cleaning validation team to develop protein manufacturing bioreactor and clean-out-of-place (COP) procedures, swab and rinsate recovery studies for microbial content, TOC, and Conductivity for protein manufacturing. Interfaced with validation, device engineering, and contract device manufacturers to implement AAMI / ISO compliant device radiation sterilization validation and periodic dose audit programs per the VDmax ISO standard.
Sr. Quality Control Associate
Set-up and implemented the first Dendreon QC Microbiology laboratory for the Seattle clinical cell processing and protein manufacturing facility. This included evaluating and redesigning the environmental monitoring (EM) program to focus on greater efficiencies, cost reductions, while utilizing a more risk-based approach to the EM program. Wrote and implemented procedures such as media growth promotion, endotoxin release testing methods, and microbial identification. Responsible for training other analysts, and providing oversight of the satellite environmental control and microbiological product testing programs at other clinical cell processing sites for harmonization. Wrote EM summary trend reports for multiple cell processing sites and analyzed alert/action levels and adjusted based on historical data. Team member in developing microbiological cleaning validation plan for chromatography skids and protein purification areas.
ICOS Corporation
Sr. Quality Control Associate | May 1999 – Nov 1999
Performed sampling and testing in support of the EM and water monitoring programs for the ICOS biopharmaceutical manufacturing plant. Cleaning validation team member for the bioreactor, fermentation, and purification areas. Responsible for creating and revising SOP’s as needed. Validation work in support of steam-in-place (SIP), clean-in-place (CIP), and clean-out-of-place (COP) cleaning validation concerning bioburden, endotoxin, and total organic carbon removal.
Dendreon Corporation, Seattle WA
Contract Consultant | April 1999
Consulted for Dendreon in the writing of an environmental monitoring (EM) program assessment and creation of EM implementation policy. Created microbiology laboratory SOPs, EM procedures, and sampling methods to prepare company for initiating an in-house microbiology sampling and testing laboratory. Performed return on investment (ROI) for bringing in microbiology test procedures in-house to reduce contract laboratory costs.
Xcyte Therapies, Seattle WA
Microbiologist | 1998 – 1999
Responsible for identifying and procuring laboratory test equipment, materials, and supplies for setting up the Xcyte QC microbiology laboratory for the Seattle clinical facility. Provided research in order to provide cost effective, reliable, and compliant laboratory sampling and testing equipment. Responsible for creating the Xcyte microbiological laboratory methods and procedures.
CellPro, Inc., Bothell WA
Microbiologist | 1993 – 1998
Responsibilities for overseeing the Quality Control microbiology laboratory function including designing EM programs and systems, sterility testing and bioburden methods. Microbiology lead responsible for training new microbiologists. Performed microbiological product testing including final product sterility, bioburden, endotoxin, microorganism identification, and biological indicators testing for sterilization validations. Participated in successful Quality System and FDA inspections both pre and post approval. Developed and validated microbiological tests including device bioburden recovery and sterility for sterile products and devices. Developed the aseptic fill EM program for new semi-automated filling line to increase manufacturing output. Performed device dose audits, execution of bioburden recovery studies, and sterility testing in support of device radiation sterilization per current AAMI and ISO standards. Maintained water quality and environmental quality databases. Member of multiple project teams interfacing with Engineering, Manufacturing, Facilities, and QA.
Abbott Research, Bothell WA
Research & Development Technician / QC Technician | 1987 – 1993
Responsible for building, and testing of in-vivo continuous blood gas fiber-optic medical devices. Participated on teams responsible for new fiber-optic sensor designs and microscopic manufacturing techniques. Responsible for training new technicians in manufacturing processes and device functional testing. Performed microbiological quality control testing for device bioburden, toxicity, and endotoxin testing by the LAL gel-clot assay. Performed environmental monitoring (EM) of class 100 LAFs and class 10,000 clean room facility.
