Cell Therapy
Cell therapy involves the introduction of new, healthy cells into a patient to replace damaged or missing ones.
These cells can be sourced from the patient (autologous) or a donor (allogeneic).
Cell and Gene Therapy
Understanding the Revolutionary Therapeutic Approach
Cell and gene therapy represent a significant advancement in medical science, offering hope for curing previously incurable conditions.
The success of these therapies relies heavily on precise and reliable manufacturing processes and quality assessments.
METTLER TOLEDO's advanced instruments and software solutions play a crucial role in supporting these innovative treatments, ensuring they are safe, effective, and of the highest quality.
Understanding Cell and Gene Therapy
Cell and gene therapy (CGT) represent transformative advancements in modern medicine, aiming to treat and potentially cure diseases by repairing or replacing malfunctioning cells or genes.
These therapies offer groundbreaking potential for conditions previously considered untreatable.
CGT addresses the root causes of diseases, offering long-term and potentially permanent solutions.
Gene therapy can introduce a healthy copy of a gene into cells, while cell therapy can replace damaged cells with healthy ones.
Gene Therapy
Gene therapy focuses on modifying or replacing defective genes to cure genetic disorders.
This involves inserting genetic material into cells to correct or replace faulty genes, often using viral vectors to deliver the therapeutic gene.
See Upstream and Downstream production processes on the scheme.
The Manufacturing Process
The manufacturing process for CGT involves several complex steps to ensure therapies are safe, effective, and high-quality.
Cell culture
Cell culture starts with preparing a nutrient-rich medium to grow and maintain healthy cells.
Monitoring pH and conductivity ensures optimal conditions. Cells are then expanded in a bioreactor until they reach the desired quantity.
Harvesting
Once cells have grown sufficiently, they are harvested by separating them from the growth medium through centrifugation and filtration to remove impurities and prepare them for further processing.
Purification and Formulation
Harvested cells are purified to remove contaminants, ensuring the therapy's safety and efficacy.
Finally, purified cells are formulated into a final product for patient administration.
Quality Assessment in CGT
Quality assessment is critical at every stage of CGT manufacturing to ensure therapies are safe and effective.
Various analytical methods monitor and verify the quality of raw materials, intermediate products, and final therapies.
METTLER TOLEDO's Role in CGT
METTLER TOLEDO offers a range of instruments and solutions supporting CGT development and manufacturing.
| Parameter | What is to be measured? | Why is it measured? | MT Solution | |
| UV/Vis | Absorbance/ Transmittance | To determine the concentration and purity to check contaminants, purification efficiency, and stability of the product. | UV/Vis Excellence | Offline |
| Cell count and viability | Cell count and viability | To determine the density of cell culture used during development of CGTs and the dose of the final product. | CytoDirect Cell counter | Offline |
| Characterizing cellular and biochemical parameters | Absorbance | High-throughput cellular assays aimed at determining toxicity, proliferation, or protein production of cultured cells | PlateDirect | Offline |
| pH | pH | Monitoring pH is required for the metabolism and growth of the cells. For pH optimization, cells and genes are pH-sensitive | Inline Atline | |
| Dissolved oxygen | Dissolved oxygen (DO) level | Monitoring oxygen levels is required for the metabolism and growth of the cells | Dissolved oxygen sensor | Inline |
| Conductivity | Conductivity | Monitoring conductivity is essential to ensure product quality and consistency, check if the cells are dividing, growing, or dying. | Conductivity sensor | Inline |
| CO2 accumulation | Dissolved CO2 level | Measuring CO2 concentration enables the adjustment of the nutrient delivery rate and waste removal to optimize the environmental conditions for maximum cell growth and productivity. | CO2 sensor | Inline |
| Turbidity | Turbidity | Turbidity gives an idea about the expansion of bacterial culture and the absence of contaminants. | Turbidity sensor | Inline |
| Optical density | OD 600 | Monitoring optical density helps track the growth of microbial cells and the quality of the product. | UV/Vis Excellence Spectrophotometer | Offline |
| Glucose | Enzymatic determination with UV/Vis | Quantification of glucose is needed to ensure adequate nutrients for cell growth and maintain metabolic processes, including producing proteins and other cellular components. | UV/Vis Excellence Spectrophotometer | Offline |
| Weight/Volume | Mass | Accurate weighing of each component added to ensure the product's safety and efficacy, consistency in the composition, and controlled addition of viral vector. | Atline/Inline | |
| Temperature | Temperature | The process is temperature sensitive | - | - |
| Pressure | Pressure | Measuring pressure helps to control the flow of fluid and speed of reaction | - | - |
METTLER TOLEDO Solutions for GGT
Useful Links and Documentation About GGT
