Cell Therapy Manufacturing

Overview

Cell Therapy is the transplantation of human cells to regenerate, replace and repair damaged cells and tissues. Stem cells are the ideal cells to be used for cell therapy because of their ability to replicate for long periods of time and to develop into different cell types. They have received great medical interest as a new treatment option and spurred a new age in regenerative medicine.

Esco Aster has leveraged on the Tide Motion bioreactors to establish a robust and scalable platform using macrocarriers to meet the demands for future clinical therapies.

We present our services and process optimization with quality controls and release riteria of functional and phenotypic characteristics for the translation of academic/industrial R&D into bench scale for future clinical trials and commercialization process.

Stem Cell Research Products and Services

  • Embryonic Stem Cells (ESCs)
  • Hematopoietic Stem Cells (HSCs)
  • Mesenchymal Stem Cells (MSCs)
  • Multipotent Adult Progenitor Stem Cells
  • Induced Pluripotent Stem Cells (iPSCs)
  • Neural Stem Cells (NSCs)

Global Stem Cell Manufacturing Market

Research Application bg
Research Applications
Research Applications
  • Drug Discovery & Development
  • Life Science Research
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Clinical Applications
Clinical Applications
  • Autologous Stem Cells
  • Allogeneic Stem Cells
Cell and Tissue Banking Application BG
Cell and Tissue Banking Applications
Cell and Tissue Banking Applications
  • Preservation
  • Storage
optimize extensive

An optimised bioprocess pipeline will provide for maximum yield and quality at the cost of minimum consumables. Both secreted products and cells for use in cell therapy benefit greatly from process optimisation. Optimisation performed at small scale is a perfect complement to linearly scalable bioreactors, avoiding large costs incurred when optimising in large volumes.

Having extensive 2D and 3D expansion platform experience, including our in-house BioNOCTM II carriers in Tide Motion® bioreactors:

  • We provide optimisation services for production of MSCs or MSC secreted products, both in 2D or 3D expansion platforms.
  • Parameters such as pH, glucose concentration, cell waste, cell passage number and other biological indicators are monitored upon request.
  • Our process optimisation aims for high cell count/ expansion folds with low cost through small-scale Proof of Concept (POC) mirroring large scale bioreactors

GMP Cell Banking

Frozen stem cells can be kept for extended periods of time and can still exercise their regenerative abilities upon recovery. When combined with stem cell isolation from tissue:

  • We provide a one stop solution for large volumes of on-demand stem cells to be used for autologous or allogeneic treatment.
  • We provide cell banking and storage services at our GMP facility.
  • We offer stem cell resources with developed cell culture solutions to support stem cell growth.
GMP Cell Banking

Expansion of Stem Cells for Commercial Sales

Our proprietary in-house Tide Motion® bioreactors, with the capability to house packed bed volumes ranging from as low as 0.1 L to 200 L, provides an excellent platform for the expansion of stem cells. Together with our process optimization services and cell banking services, we provide a one stop solution for all stem cells or stem cell-derived product production needs:

  • We provide large scale cell expansion services.
  • Automated cell filling capabilities
GMP Cell Banking

Mesenchymal Stem Cell Services

Cell Characterization

For MSCs to be classified as such, they are required to fulfill several criteria as specified by ISCT:

  • Plastic adherence
  • Express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79α or CD19 and HLA-DR surface molecules
  • Trilinear differentiation into osteoblasts, adipocytes and chondroblasts in vitro
Cell Characterization
  • We provide MSC population purity (phenotyping via flow cytometry) and characterization testing services and other efficacy and potency assays upon request.
  • MOA-reflective cell-based assays that can support multiple stages of the biopharmaceutical development pipeline.
  • Our process optimisation aims to fulfil the most basic standards from ISCT and additional bioassays requested.
Reagent Testing

A wide variety of reagents are used in the bioprocessing of MSCs. Such chemicals include trypsinisation enzymes, various media formulations (serum-containing/free media) and serum sources (FBS/HPL), surface coatings (fibronection, gelatin, laminin, collagen etc) and more.

Part and parcel of process optimisation, our MSC team is experienced in assessing the efficacy of MSC reagents, including identifying potentially lasting cell damage from chemical exposure.

Reagent Testing
  • We provide reagent testing and optimizing services on MSCs.
  • Parameters such as product concentration, cell exposure times, MSC health and characterization.
Mesenchymal Stem Cell (MSC) Isolation

MSCs can be isolated from a wide range of tissue sources to be harnessed for regenerative therapy. Our isolated MSCs allow for faster expansion and greater total expansion numbers due to being younger as compared to other commercial sources as we do not over-expand our cells. We expand cells based on population doubling with characterization to ensure its quality.

Mesenchymal Stem Cell (MSC) Isolation
  • We provide MSC isolation services from unprocessed tissue.
  • Flexible expansion amounts before freezing to form MCB/WCB.
  • Freezing for manufacturing (MCB & WCB)/ clinical trials