BIOLOGICS

Biologics are complex molecules which must be manufactured in living cells.  "Host cells" are genetically edited to produce (secrete) a desired protein/antibody, which in turn is harvested, purified (= biologic) and then used to treat a patient.  Genetically editing host cells involves opening their cell membrane to allow the gene to enter.  

Most drugs you use today are known as small compounds, e.g. Aspirin.  They are tiny molecules that can activate or inhibit a cellular function and can be synthesised in a chemistry lab.  But in the last 40 years, science has learned to harness this new type of drug - the biologic.  Biologics are much larger compounds, that have exponentially more possibilities in the body.

As well as affecting cellular pathways, they can actually carry out biological functions themselves.  This means they can influence diseases where an individual may not have the cellular components for an essential function.  This is something small molecules will never be able to do.  Biologics also do this with a much higher degree of specificity and a significantly lower chance of toxic side effects that small molecules.  

The first big biologic on the market was insulin and it has completely changed how the world deals with diabetes.  As research continues, more biologic drugs will be produced and there is no doubt that biologics will play a significant role in the future of medicine.  

The importance of cell counting for biologics manufacturing

A reliable cell count is crucial for many regulatory aspects of biologics manufacturing:

  • Safety, efficacy, purity, potency, identity, quality

  • Oversight of both product and process

  • Quality control of source materials, intermediates, and product

  • Reproducibility of lots

  • Comparability after manufacturing change

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HOW DOES IT WORK?

Biologics are difficult to manufacture and since the starting material are cells; the importance of quality control with respect to cell counting, viability and transfection efficiencies cannot be overstated.

One of the biggest bottlenecks within cell manufacturing is Cell Line Development (CLD): the process of turning a regular cell ("host cell") into a highly efficient cell producing the desired protein ("cell line").  To to this, the host cell is opened ("open-membrane") in the presence of the gene; the gene enters the cell and the cell closes as it's membrane seals.  The gene genetically engineers or reprograms the host cell and the result is a Cell Line which will produced the desired protein (and thus biologic) stably and with a high yield.  Cell Lines are unique to each manufacturer and are the source of all future drug product (Master Cell Bank).  They are grown in large bioreactors.  

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Cell Line Development

The process of CLD, and in particular transfection, can be quite harsh causing significant cell death.  Therefore, it is important to analyse the cell population post-transfection for overall cell count and viability.  

Cellix's Inish Analyser is the first product on the market that can instantaneously determine if the cell membrane has been successfully opened and thus, whether the gene has been delivered.  This provides un-paralleled insight into the transfection process, saving researchers days in unnecessary analysis of dead or non-transfected cells.

 

WHAT DO I NEED TO GET STARTED?

In the examples below, we highlight results from yeast cells but as genetic editing techniques becomes more widespread, so too are the cells being investigated for biologics production.  Yeast cells are a popular choice in biologics for the manufacture of cell products.  Yeast cells as "cell factories" have numerous advantages including their fast growth; the ability to easily manipulate their genetics and their compatibility with high-density large-scale fermentation processes for biochemical production.  The example below focuses on Saccharomyces cerevisiae which is one of the more popular "cell factories", successfully used in the biotechnology industry for the production of a wide variety of enzymes and therapeutic proteins. 

Materials

Our Inish Analyser does not require any expensive consumables such as slides or cartridges.  Instead we use standard microcentrifuge tubes (1.5mL).  Sample preparation is very simple - just using a pipette. 

In general, you will need the following to execute Cell Counting & Viability and Transfection Efficiency assays:

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Cell Sample Preparation

Culture yeast cells in the recommended medium / PBS.  Ensure that the cells are in suspension.  Recommended cell concentration is 50,000 - 2,000,000 cells/mL.  Vortex cells or pipette cells up and down to ensure a homogenous solution.

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Results of Cell Counting & Viability Assay

Cell Counting & Viability of Yeast cells (Saccharomyces cerevisiae)
Cell Counting & Viability of Yeast cells (Saccharomyces cerevisiae)

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Cell Counting & Viability of Yeast cells (Saccharomyces cerevisiae)
Cell Counting & Viability of Yeast cells (Saccharomyces cerevisiae)

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