A complete process technology documentation package is provided, including detailed process flow diagrams and descriptions for all unit operations, a complete bill of materials, equipment lists, copies of batch records, a sampling plan, and all applicable SOPs and product-specific analytical procedures.  On-site training is conducted at our San Diego facility at the 20 liter scale for all fermentation, purification, and analytical operations.  At the conclusion of this stage of work, the production process is ready for transfer to a GMP manufacturing facility.