Stanley Chi-ho Kwok

Executed experiments on product prototypes, analysing results to determine effectiveness.

• Developed automation platform for cell and gene therapy in collaboration with product teams.
• Characterised new vessel variants on Ambr250 HT bioreactor to enhance performance.

Conducted fault diagnosis and provided test feedback to engineering teams.

• Scaled up T-cell culture processes to 1L rocking-motion bioreactor.
• Mentored junior team members, fostering knowledge development in experimental procedures.
• Prepared data reports and presented findings to project stakeholders regularly.

• Manufactured cell-based cancer vaccine drug product to support Marketing Authorisation Application.
• Reviewed GMP manufacturing processes and identified critical optimisation parameters.
• Conducted root-cause analysis on failed batches, presenting findings to stakeholders.
• Devised refined processes to optimise manufacturing and reduce production costs.
• Regularly presented data to team members and project stakeholders.
• Prepared comprehensive project reports on process development.
• Developed and revised SOPs for manufacturing processes and laboratory protocols.
• Liaised with QA, QC, and production staff for documentation and project development.

• Company Overview: (Position offered but company operations ceased before commencement – reference available upon request)
• (Position offered but company operations ceased before commencement – reference available upon request)

Established GMP Manufacturing Platform for Advanced Therapy Products

• · Collaborated with project team to implement GMP quality system for CAR-T cell product manufacturing
• Designed and validated SOPs for CAR-T cell manufacturing using CliniMACS Prodigy
• · Executed equipment impact analysis for CAR-T cell production process.
• Drafted SOP for operation and maintenance of GMP supporting equipment
• · Developed aseptic techniques for medium transfer and sterile tubing welding and provided trainings to junior staff

Research on project entitled 'Bioprocess Platform Development for Advanced Therapy Medicinal Product Manufacturing'

• · Facilitated partnerships with medical faculty research fellows to initiate projects.
• Developed and scaled adipose-derived mesenchymal stem cell cultures from 2D adherent systems to 3D suspension bioreactor platforms (Eppendorf DASbox, 200 mL).
• Implemented rapid analytical method for cell culture bioprocess monitoring using Process Analytical Technology (PAT) approach

Development of Xenogeneic cell based medicinal product (XCP) – Provided consultation based on client request for development of XCP

• Reviewed XCP relevant regulatory guidelines in Europe and Germany, discussed with project team and prepared report to project owner and project manager in regular basis.
• Liaised with Contract Research Organizations (CRO) and regulatory officials in Germany (Paul-Ehrlich-Institut, PEI) for XCP development process
• Developed SOP for XCP manufacturing in compliance with GMP operation
• Presented project to different stakeholders and potential collaborators in regular basis.

Secondment in Quality Assurance Department for GMP manufacturing of Chinese Medicinal Product

• Liaised with Production staff to ensure all production procedures were strictly followed to SOP
• Reviewed production SOP and batch record
• Offered training to production staff for refreshment and continuous improvement in production process

Spearheaded multiple government-funded industrial collaborations on bioprocess innovation of E.coli fermentation.

• Conducted E.coli fermentation using bench-top 2 Litre stirred-tank fermentor for culture seed preparation
• Performed scale up fermentation in pilot-scale stirred-tank fermentor (100L) for recombinant plasmid DNA manufacture

• Design and Development of Novel Bio-interactive Electro-chemical Wound Dressing Incorporating Physical Vapour Deposition of Nanoscale Silver Ions
• Developed ex vivo culture models for wound healing research.
• Conducted histological and cytotoxicity analysis of wound dressings.
• Led keratinocyte and fibroblast culture studies for skin regeneration.