Process Development and Manufacturing

Our mission is to produce CGMP-compliant cell and gene therapies at scale for use in clinical research, while collaborating with principal investigators and LCGM cross-functional teams to ensure product efficacy, safety, and quality.

Our Role:

In Process Development, personnel work with researchers at the Stanford School of Medicine to translate cell and gene therapies from the laboratory to the clinic. LCGM’s Process Development team possesses decades of experience that they use to optimize production at scale while developing consistent, effective, and safe techniques for use by LCGM Manufacturing personnel.

In Manufacturing, personnel work using CGMP procedures under aseptic conditions to produce cell and gene therapies for life-threatening illnesses. These therapies go to treat patients participating in Phase I and Phase II clinical investigations at Lucile Packard Children’s Hospital and Stanford Hospital.

Our Process Development and Manufacturing teams develop ingenious large scale, closed system and cGMP compliant manufacturing processes and manufactures innovative cell and gene therapies.

Process Development:

  • Scale up/scale out/technology development
  • Raw materials/vendors sourcing, qualification
  • In process/release test development
  • Process and reagent qualification

Clinical Materials Production:

  • Cell Selection (Phenotype, cytokine expression, size)
  • Cell expansion (flasks, static bags, bioreactor)
  • Genetic modification (Viral Tdx, CRISPR, etc.)
  • Cell/Device Preparation (Skin grafts, iPSC-derived grafts)
  • Viral Vector Production (AAV, Lentivirus)

LCGM operates based on Current Good Manufacturing Practice (CGMP), which comprises standards based on company policies and procedures, professional guidance from organizations such as the International Society of Cellular Therapy (ISCT), consensus standards, regulatory guidance, and the law. In Process Development and Manufacturing, performing to CGMP standards includes practices such as:

  • Operating based on qualified Standard Operating Procedures (SOPs) and Batch Records using aseptic technique in a qualified ISO clean room environment
  • Ensuring personnel are trained on all procedures in a thorough, consistent, and well-documented manner
  • Controlling all production materials based on material management procedures and systems
  • Performing environmental and personnel monitoring to maintain and track sterility
  • Filling out and maintaining documentation of training, qualification, and processes based on Good Documentation Practice (GDP).

In the Process Development laboratory, LCGM personnel translate Stanford faculty research into CGMP-compliant, patient-scale processes.

The Process Development and Manufacturing team employs state-of-the-art closed-system technology to manufacture patient therapies.

LCGM contains six qualified clean rooms in which the Manufacturing team produces sterile, safe, effective therapies for patients with life-threatening conditions.