COMPANY OVERVIEW

Charles River Laboratories Cell Solutions, Inc. is a leading provider of apheresis products, human blood cells, and apheresis collection services, with over 30 years of experience. We supply human-derived blood components for preclinical and clinical applications in biologics, immunotherapy, cell therapy, assay development, and medical devices.

Human cells and tissue are critical raw material for cell therapy, tissue-engineered, and ex vivo gene therapy products. Quality of this cellular raw material is a major determinant of final product characteristics, but is complicated by inherent heterogeneity and inter-individual variability of living biologics. Inconsistent collection procedures amplify this variability, adversely affecting the manufacturing process from the outset. Controlled, consistent cell collection minimizes variability, and enables successful manufacturing.

Our core competency is apheresis collection, and, building on over 35 years of experience, has addressed this need for optimized cell collection with a program for controlling and qualifying its apheresis procedures and collection sites, to supply human-derived blood components for development and qualification of novel cell and gene therapies, assays, and medical devices. Our apheresis program includes:

• Comprehensive staff qualification and training
• Documentation that supports its cGMP environment
• Programs to monitor effectiveness of equipment and procedures in accordance with an established quality system
• Donor recruitment, screening and IRB-approved consents following the requirements of GTPs

OUR EXPERIENCE

From 2007-2012, Charles River Laboratories Cell Solutions, Inc. performed over 90,000 apheresis procedures, including collection of patient and normal-donor peripheral blood mononuclear cells, mobilized peripheral blood progenitor cells, and plateletpheresis products. Charles River Laboratories Cell Solutions, Inc. supports preclinical research, clinical studies from Phase I to Phase III, as well as commercial applications.

PRODUCTS AND SERVICES

Our human derived biological products are collected in accordance with cGMP and cGTP requirements in our FDA-registered collection centers in accordance to your specific protocols. We provide a variety of fresh and cryopreserved human primary blood cells isolated from a variety of tissues from normal donor subjects and patients including:

• Peripheral blood
• Mobilized peripheral blood
• Bone marrow – coming soon
• Cord blood – coming soon
• Customized collections and isolations

THE DIFFERENCE

• Large registry of repeat-donor subjects
• Controlled, consistent, and readily available primary human cells - apheresis products and PBMCs
• Predictable, reliable, and validated collection procedures
• Ability to collect based on specific protocol
• High-yield cell collections
• Validated, automated cell counts and five-part WBC differentials
• IRB approved collection protocols and subject consents
• Optimized Standard Operating Procedures (SOPs) and proven quality systems