Cell Therapy Development & Manufacturing

Cellular therapies are truly changing the course of health care for some of our most challenging disease indications, and the biopharmaceutical industry needs contract development and manufacturing solutions to accelerate delivery of these innovative products to patients.

Located in our Woodlands TX office, KBI's Cell Therapy team has been managing a fully functional manufacturing facility supporting cell therapies and have been developing therapies under IND since 2001. Our team has substantial expertise and knowledge in the manufacturing, process development and regulatory aspects of cellular therapies as well as maintain strong relationships with the US FDA and Health Canada.

KBI provides the following Cell Therapy services:

Phase I/II GMP manufacturing capabilities in ISO 7 clean rooms
Our GMP cell culture facility offers three independent culture suites, unidirectional flow of personnel and materials, and environmental monitoring to support quality manufacturing processes.

Process Development
KBI’s Process Development capabilities allow us to translate basic science assays into robust, reproducible, scalable manufacturing processes to accelerate a client’s clinical development program.

Parallel processing of cell therapy products
Through stringent control of processes, materials and equipment, we can process numerous products for a single client’s project in parallel, thereby reducing cost and time required for a project.

Clinical Logistics
We provide centralized receipt, manufacture, and supply of patient materials to facilities across North America.

Therapeutic Products
KBI offers the ability to develop and manufacture cellular therapeutics for clinical indications including autoimmunity, immunoncology, and regenerative medicine

KBI’s Cell Therapy Capabilities

    • Development projects may be ‘stand alone’ or part of a fully integrated GMP manufacturing project

    • Facilitate technology transfer from client

    • KBI Development lab process runs per client protocols

    • Optional Optimization of Process for the purpose of maximizing quality, scalability, and reproducibility including:

      • Cell culture configuration
      • Media optimization
      • Growth factor feeding strategies
      • Monitoring and control of cell culture metabolites
      • Passage, Expansion
      • Cryopreservation
    • Process Development can be tailored to client needs, including but not limited to:

      • Transition from open culture system to functionally closed system
      • Scale out or scale up to meet dosing requirements
      • Capacity evaluation to determine appropriateness of parallel processing
      • Product comparability and Stability studies
      • Cryopreservation and Dose Delivery mechanisms development
      • Transition to a Phase I/II compliant manufacturing process
    • Product Identification, Quality, Purity

      • Cell surface marker expression, viability
      • Comprehensive Flow Cytometric-based Characterization
    • Product Activity, Potency

      • Cytokine secretion via ELISA or Bead-based multi cytokine detection
      • Number of cells secreting cytokine of interest by ELISPOT
      • In vitro cell activation, cell cycle analysis
      • Cellular proliferation and expansion
      • Luminescence based Cytotoxicity assays
      • Gene expression, genotyping, copy number, microRNA
    • Product Stability, Safety

      • Stability Bioassay with Product Characterization
      • Sterility testing to include endotoxin, mycobacteria, and bioburden
      • Release testing to include infectivity of virally transduced cell lines
    • Conventional T cells

    • Regulatory T cells

    • Dendritic cells

    • Macrophages

    • B cells

    • NK cells

    • Stem cells

    • Tumor cells

    • Cell Lines

    • Genetically engineered cells (CAR-T, TCR)

    • Antigen-specific T cells

    • Tracking of incoming, in process, and outgoing clinical trial materials

    • Controlled temperature specimen transport using Qualified and Validated Shippers

      • Room Temperature: 20°C-24°C, 15°C-25°C
      • Refrigerated: 2°C-8°C, 1°C-10°C
      • Frozen: Sub -18°C
      • Deep Freeze: Sub -40°C
    • Closed system & single use reagent formulations

    • Parallel processing of cell therapy products

    • Isolation & tracking via unique sample identifiers

    • Fill & Finish per client’s instructions

View Capabilities