Mehwish S Khan

Regenerative Medicine Clinical Center, WFU Health Sciences      

 GMP Manufacturing Technician II

January 2012- April 2014​

 

• PROJECTS: AFSC, ADSC, AIT, MPC, placental stem cells, bioengineered urethra.

• Amniotic Fluid Stem Cells (AFSC):

  • Optimized isolation, expansion, and cryopreservation protocols to suit GMP/GTP regulations.

  • Created Master Batch Records for the procedures.

  • Established GLP standard AFS cell banks for definitive and pre-IND studies.

• Adipose-derived Stem Cells:

  • Optimized isolation, expansion, and cryopreservation protocols to suit GMP/GTP regulations.

  • Created Master Batch Records for the procedures.

  • Collaborated with Dr. Peter Rubin and team at the University of Pittsburg and Dr. David Kaplan and team at the Tufts University to process clinical lipoaspirate samples to develop ADSC isolation procedure and banking techniques.

• Autologous Islet Transplantation (AIT):

  • Involved in AIT technology transfer and development at the RMCC.

  • Isolated islets from human cadaver pancreas.

  • Involved in the optimization of AIT Technology to meet GMP standards

• Muscle Precursor Cells (MPC):

  • Developed and optimized a flow panel for the characterization of MPCs.

  • Worked on definitive studies for IND submission using MPCs for Stress Urinary Incontinence (SUI).

• Bioengineered Urethra Project:

  • Received training from Dr. Diego Esquiliano on the following:

    • Isolation of urothelial and smooth muscle cells from pig bladder biopsy.

    • Expansion and characterization of urothelial and smooth muscle cells

    • Cutting, sewing, coating and sterilization of the synthetic scaffold.

    • Seeding of urothelial and smooth muscle cells on the scaffold for the Neo-Urethral construct.

    •  Media change within the bioreactor

    • Release testing for the final product

• Developed and optimized phenotype characterization protocols for MPC, AFSC and ADSC.

• Worked in the process development and optimization team on developing GMP compliant procedures for the Bioengineered Human Urethra and Placental Multipotent Progenitor Cells (PMPC) projects.

  • Created experimental designs; executed experimental protocols; collected, compiled, and analyzed data; wrote detailed formal technical and study reports.

• Trained in GLP, GTP, GMP and GDP.

• Worked closely with Quality Assurance and Quality Control teams on all projects.

• Environmental monitoring of the classified area for the Quality Control

• Collect and submit samples for testing in the Quality Control lab

• Worked in ISO 8 and ISO 7 classified areas.

• Created SOPs for GMP facilities and equipment; involved in deviation documentation (writing and filing).

• Performed preventative maintenance (PM) of equipment in classified areas.

• Stocking of the ISO 7 classified area.

• Assist in the calibration of equipment in the classified area.

 

Wake Forest Institute of Regenerative Medicine

Lab Technician ll

​2010 -2012

 

• Isolation and culturing of amniotic fluid stem cells (AFSCs).

• Cryo-preservation and banking of AFS cells.

• Growth kinetics and doubling time analysis.

• Separation of AFS cells using magnetic beads.

• Differentiation AFS Cells into adipogenic, osteognic and chondrogenic lineages.

• Characterization of AFS cells using immunohistochemistry and flow cytometry.

• Isolation of adipose-derived stem cells (ADSC) from animal and human adipose tissue.

• Cell growth, banking and cryopreservation of ADSC.

• Isolation of Placental Multipotent Progenitor cells (PMPC) from human placenta.

• Growth, banking, and characterization of PMPC.

• Created SOPs for AFSC, ADSC and PMPC projects.

• Created master/manufacturing batch records for these projects.

 

 Targacept Inc.

Lab Technician 

April 2010 - October, 2010

 

• Performed Cell culture for all electrophysiology experiments.

• Maintained 8 different cell lines with specific receptor subtypes.

• Performed patch clamp electrophysiology experiments using Dynaflow medium throughput technology.

• Developed and implemented compound inventory system.

• Prepared buffers and all cell culture media.

• Ordered and stocked laboratory supplies.

Tengion  Inc.

Research Associate 

2007 - 2009

• Performed cell isolation and culturing procedures to produce neo-organs for large animal studies and

      human clinical trials.

• Good Manufacturing Practices (GMP) Trained and Certified.

• Trained and qualified for aseptic processing in Class 10,000 clean rooms.

• Designed and executed experiments for the development of new regenerative medical products.

• Prepared (molding and sewing) and coated human bladder scaffolds for research and clinical trials.

• Performed general maintenance operations for equipment and laboratory facilities.

• Assembled bioreactors for human and animal clinical trials.

• Assist QC for the environmental monitoring of the processing.

• Collect and submit samples for testing in the QC lab.