PoC studies in cell banking are designed to ensure that microbial strains remain viable, stable, and reproducible after being stored for long periods, enabling their use in various industrial and research applications. These studies are essential to demonstrate the practical feasibility of microbial cell banking in ensuring continuous production and product consistency across multiple sectors.
Objective: PoC studies first validate the selection of cell banks. The strains may be isolated from natural sources or engineered for specific biotechnological purposes.
Focus: Ensuring that strains have the desired genetic characteristics, such as the ability to produce a particular bioactive compound or the resistance to specific environmental conditions.
Objective: Demonstrating that strains can be successfully preserved and stored in a way that maintains their viability and functional properties.
Focus: Methods like lyophilization (freeze-drying) or cryopreservation are tested for their ability to preserve the integrity of the strains. PoC studies help ensure that cell banks can be revived and cultured after storage without losing their original traits.
Objective: To determine the long-term stability of cell banks under storage conditions and evaluate their performance in downstream applications (such as fermentation, enzyme production, etc.).
Focus: This involves regular testing of cell banks after storage for months or years to assess genetic stability, metabolic activity, and their ability to perform in industrial processes. The PoC study will look at factors like genetic drift, contamination risk, and loss of desired properties.
Objective: Verifying that the cell banks consistently produce the same results when cultured and used in experiments or production processes.
Focus: PoC studies test whether cell banks from different batches show the same biochemical activity, growth characteristics, and yield, ensuring that they remain reproducible over time.
Objective: Evaluating the recovery process of cell banks after thawing or reactivation from the cell bank. This includes ensuring the viability of the cells after being stored for a period.
Focus: Testing different thawing and reactivation techniques to ensure that the cell banks recover their full activity post-storage, without significant loss of viability or performance.
Objective: Validating protocols for quality control (QC) to ensure that only pure, high-quality cell banks are included in the facility.
Focus: This may include testing the absence of contaminants (e.g., bacteria, fungi, viruses) and ensuring the strain is free from mutations or genetic alterations that could affect product quality.
Objective: Ensuring that cell banks can be used in large-scale production, without issues related to scalability.
Focus: The PoC study may test whether the cell banks can be successfully grown in large bioreactors and produce the desired product at a commercially viable scale, ensuring that banked strains are suitable for industrial applications.
Objective: Testing the cell banking process for compliance with regulatory standards.
Focus: PoC studies ensure that cell banks meet regulatory requirements for safety and quality control. This is especially important in industries like pharmaceuticals, where cell banks used for the production of drugs or vaccines mustadhere to strict regulations.