Production of Biopharmaceuticals from Animal Cells
Introduction
Biopharmaceuticals are drugs that are produced using living cells, typically animal cells, through a process known as bioprocessing. These drugs have revolutionized the treatment of many diseases and disorders, including cancer, autoimmune disorders, and genetic disorders. Biopharmaceuticals have several advantages over traditional chemical drugs, including increased specificity and potency, reduced side effects, and improved patient outcomes.
The production of biopharmaceuticals from animal cells involves a complex process that includes cell line selection, transfection, bioreactor culture, downstream processing, and quality control. The selection of a suitable cell line is critical for the success of biopharmaceutical production, and a variety of cell lines have been used, including CHO cells, mouse myeloma cells, and HEK cells. Transfection methods are used to introduce foreign DNA into the animal cells, which can then be cultured in large-scale bioreactors. Downstream processing is used to purify and formulate the biopharmaceutical product, and quality control measures are taken to ensure safety and efficacy.
Biopharmaceuticals are complex molecules that are derived from living organisms such as bacteria, yeast, or animal cells. These molecules are used to treat a wide range of diseases, including cancer, autoimmune disorders, and genetic disorders. One of the most common methods of producing biopharmaceuticals is by using animal cells.
Animal cell culture is the process of growing animal cells in vitro, or outside of their natural environment. These cells can be grown in large quantities and used to produce biopharmaceuticals.
Technology advancements are causing gains in efficiency and safety in the field of biopharmaceutical production, which is a fast changing industry. Regulatory organizations actively monitor the quality and safety of new cell lines, transfection strategies, bioreactor designs, and downstream processing procedures.
Cell Line Development
Cell line development is a critical step in the production of biopharmaceuticals from animal cells. A cell line must be capable of producing high levels of the desired protein, and it must be stable over multiple passages to ensure consistency in the final product.
Cell line development typically involves genetic engineering techniques, such as transfection or gene editing, to introduce the desired genetic sequence into the animal cells. The cells are then screened for protein expression levels, stability, and other properties. The most promising cell lines are selected for further development.
Transfection
Transfection is the process of introducing foreign DNA into animal cells. The foreign DNA contains the genetic sequence for the desired protein or molecule to be produced. Transfection can be done using either viral or non-viral methods.
Viral transfection involves using a virus to introduce the foreign DNA into the animal cells. The virus is engineered to carry the desired DNA sequence, and it infects the animal cells, allowing the DNA to integrate into the cell's genome. This method is highly efficient, but it can be expensive and time-consuming.
Non-viral transfection involves using chemicals or physical methods, such as electroporation or microinjection, to introduce the foreign DNA into the animal cells. This method is less efficient than viral transfection, but it is simpler and less expensive.
Bioreactor Culture
Once the animal cells have been transfected with the foreign DNA, they can be cultured in large-scale bioreactors. Bioreactors are vessels that provide the optimal conditions for cell growth and protein production, including temperature, pH, and nutrient availability.
There are several types of bioreactors, including stirred-tank bioreactors, perfusion bioreactors, and micro carrier bioreactors. Stirred-tank bioreactors are the most commonly used type and can produce large quantities of protein. Micro carrier bioreactors use small beads to grow the animal cells and can produce high-density cultures. Perfusion bioreactors provide a continuous supply of fresh nutrients to the animal cells, allowing for longer culture times and higher protein yields.
Downstream Processing
After the animal cells have been cultured in the bioreactor, the biopharmaceutical product must be purified and formulated. Downstream processing is used to separate the desired protein or molecule from the other cellular components and contaminants.
Downstream processing typically involves several steps, including cell harvesting, cell disruption, clarification, chromatography, and formulation. Cell harvesting involves removing the animal cells from the bioreactor, and cell disruption involves breaking open the cells to release the desired protein or molecule. Clarification is used to remove cellular debris and other contaminants from the protein solution.
Chromatography is a key step in downstream processing and involves separating the desired protein from other proteins and impurities in the solution. This is typically done using a column packed with a specific resin that selectively binds to the desired protein. The protein is then eluted from the column and further purified if necessary.
Quality Control
Quality control is an important aspect of biopharmaceutical production from animal cells. Regulatory agencies require that biopharmaceuticals meet strict standards for safety, efficacy, and purity. Quality control measures are in place throughout the entire production process, from cell line development to final product release.
Quality control testing includes a range of analytical methods, such as high-performance liquid chromatography (HPLC), mass spectrometry, and bioassays, to ensure that the final product is free of contaminants and meets the desired specifications.
Future directions
Advances in technology are driving improvements in the production of biopharmaceuticals from animal cells. New cell lines are being developed that can produce higher yields of protein, and new methods for transfection and downstream processing are being explored. In addition, new bioreactor designs, such as single-use bioreactors, are being developed to improve efficiency and reduce contamination risks.
The advantages of making biopharmaceuticals from animal cells include:
1. Increased specificity and potency: Biopharmaceuticals produced from animal cells are highly specific and potent due to their ability to target specific molecules or receptors in the body. This allows for more effective treatment of many diseases and disorders, including cancer, autoimmune disorders, and genetic disorders.
2. Reduced side effects: Biopharmaceuticals produced from animal cells have fewer side effects than traditional chemical drugs because they are made from natural biological molecules that the body recognizes and processes more easily.
3. Improved patient outcomes: Biopharmaceuticals produced from animal cells have been shown to improve patient outcomes, leading to longer survival rates, reduced hospital stays, and improved quality of life.
4. Customizable: Biopharmaceuticals produced from animal cells can be customized to fit individual patient needs, allowing for personalized medicine.
5. Less environmental impact: The production of biopharmaceuticals from animal cells has a lower environmental impact than the production of traditional chemical drugs because the process uses fewer chemicals and generates less waste.
6. Rapid development: Biopharmaceuticals produced from animal cells can be developed more rapidly than traditional chemical drugs because the process allows for quicker identification and testing of potential drug candidates.
7. Greater potential for innovation: Biopharmaceuticals produced from animal cells have greater potential for innovation because they are made from natural biological molecules that can be modified and optimized to create new treatments for a wide range of diseases and disorders.
Several crucial processes, including cell line creation, transfection, bioreactor culture, downstream processing, and quality control, are involved in the synthesis of biopharmaceuticals from animal cells. Using genetic engineering methods, the required genetic sequence is inserted into animal cells during cell line development, and the most promising cell lines are chosen for further development. The ideal circumstances for cell growth and protein production are provided by bioreactor culture, and the target protein or molecule is separated from other biological components and impurities via downstream processing. To guarantee that the finished product satisfies stringent requirements for purity, effectiveness, and safety, quality control procedures are implemented throughout the whole production process.