Karin Hermans, PhD
ISCT Lab Practices Committee Member
The Hospital for Sick Children (SickKids)
Canada
Monica Klein, MD
ISCT Lab Practices Committee Member
Mayo Clinic
United States
This month’s LPC Snapshot offers an in-depth exploration of the regulatory framework distinguishing minimally manipulated products from those that undergo more extensive manipulation. It also examines the current Good Manufacturing Practices (cGMPs) that must be followed to guarantee the safety, identity, purity, potency, and overall quality of drug products. By delving into these regulatory considerations, the Snapshot aims to clarify the requirements and standards that guide the production and oversight of cellular therapies, ensuring consistent quality and patient safety across the industry.
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