ISCT Lab Practices Committee

1
ISCT Lab Practices Committee

• Who are we What do we do?

2
Initial Efforts (2001-2002)

• Identify potential committee members
• Establish an effective means of communication
• Identify areas of focus
• Develop working relationship with other ISCT
  committees
• Develop MISSION Statement

3
Mission Statement (2003)

• To help develop, standardize and disseminate
  accepted laboratory practices for clinical
  applications of cellular therapy
• To participate in the translation of novel cell
  therapy products from the laboratory to the
  clinic
• To encourage and foster the participation of
  laboratory practitioners in all aspects of the
  society

4
Education

• Standardization of common Standard Operating
  Procedures and Practice
• Encourage society membership amongst technical
  staff
• Scheduling of Teleconferences
• Review and discuss practical operational topics
• Discuss various labs approach to common issues
• Develop consensus amongst various labs where
  applicable
• Actively participate in societys conferences
• Technical Breakfast
• Round Table Discussion Groups
• In-service training with wet lab demonstrations

5
Regulatory Development

• QA Issues
• Audits
• Documentation Control
• Facility Cleaning
• QC Issues
• In-house vs. Out-sourcing of test
• Environmental Monitoring
• Participation in method comparisons
• RA Issues
• Laboratory Involvement in clinical trails
  development and execution
• Documentation to meet cGCP

6
Staffing Requirements

• Job Descriptions
• Adequate for the technical task
• Graduated levels for advancement opportunities
• Enhance recruitment efforts
• Staffing ratios and overlapping positions
• Cross-check functionality
• Pro-active audits
• Multi-tasking across divisions of labor how to
  share positions
• Certification

7
Developmental Research

• Translation of developmental research into cGMP
  environment
• Understanding of development issues and
  scientific technology
• Scale-up and Close-up issues
• cGCP and how it applies to the laboratory staff
• Successful protocol implementation
• Process and time integration

8
cGMP Facility Operations

• Actively participate in construction process
• Work-flow
• Shared equipment spaces
• Multi-purpose units
• Optimal cleaning processes
• Changeover policies
• Gowning standardization
• Validation

9
Next Steps

• Active integration into societys growth and
  expansion
• Pioneering and implementing new procedures
• Streamline processes
• Improve resource utilization
• Efficient scale-up
• Development of closed system
• Cost Management