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A single-use bioreactor is a kind of bioreactor that uses disposable or single-use materials throughout the whole production process. They are especially suitable for the fast-growing cell therapy and gene therapy markets.
Single Use Stirred Tank Bioreactor:
The stirred tank reactor is an animated bioreactor with internal impeller mixing devices. It actively mixes broth compositions by itself, including air, microbes, and fuel. The impeller creates a consistent, circular flow that moves the contents of the tank upward, outward, and downward, repeating the process. Single use stirred tank bioreactors play an important role in vaccine and antibody production.
Single use Disposable bag bioreactor:
Single use disposable bag bioreactors are one of the bioreactors parts or vessels are made from single use or disposable materials. They have a few benefits over traditional bag bioreactors. For example, they can make bioprocessing easier and more hygienic by decreasing the amount of cleaning and validation that is required for these. At the same time, they can reduce the cross-contamination risk and improve product purity. Furthermore, single use bags enable faster changeover times for higher throughput in manufacturing.
Single use Airlift bioreactor:
Airlift reactors are animated reactors without any moving parts. They use fluid flow to mix broths made up of air, microbes, and other compositions. Fresh broth mixture entry pushes the settled culture upward in the column. Then, gravity pulls it downwards in the separation zone where there are no inflows. Airlift reactors are used for both solid-state and liquid fermentation. Single-use airlift bioreactors have become a more flexible bioprocessing solution because of their simplicity, reduced risk of contamination, automation compatibility, and cost-effectiveness. They ideally suit high cell density cultivation and scale-up for the production of biofuels, food additives, and organic compounds.
Working Volume:
The range of working volume that single-use bioreactors are capable of.
Design:
Single-use bioreactors are often designed with a particular shape and structure to meet different cell culture or fermentation requirements.
Material:
Single-use bioreactors are often made of plastic or other disposable materials with characteristic sterility, biocompatibility, and permeability, among which the specific materials and grades are often required to meet certain quality standards.
Process Parameters:
Such as temperature, pressure, pH value, dissolved oxygen, and other controllable and adjustable ranges. These parameters are crucial for cell growth and metabolic processes, fermentation reactions, etc.
Sterilization:
Many single-use bioreactors are capable of sterilizing in situ to ensure the sterility of the culture environment and reduce cross-contamination risk.
Data Acquisition and Control System:
Such as real-time monitoring and control of process parameters, data acquisition, and storage functions, etc.
Safety and Compliance:
Single-use bioreactors must comply with relevant safety standards and regulatory requirements, such as FDA, EMA, etc., to ensure their application in pharmaceutical, biotechnology, and other industries.
Pre-Maintenance:
Before maintenance, the sterile bioreactor environment should be established. Wash hands thoroughly with soap and water, put on sterile gloves or other sterile wear, and make sure that sterile tools and equipment are used during the operation to reduce the risk of infection.
Clean and Disinfect:
Clean the surface and internal parts of the bioreactor with a suitable detergent and disinfectant. Ensure that all residues and contaminants are thoroughly removed. Pay attention to the cleaning of key parts such as valves, pipes, and sensors. This step is crucial to ensure that single-use bioreactors are free from contaminants and reproducibility of the next experiment.
Replace Single-Use Components:
For those single-use bioreactors that have replaceable components, such as bags, filters, etc., ensure that the replaced components are sterilized and comply with relevant standards.
Check and Calibrate the System:
Check and calibrate the parameters and control system of the bioreactor, including process control, measurement system, and data acquisition and control functions, etc. Ensure that all components are functioning properly, and relevant process parameters are accurately set.
Document and Track:
Record and track the maintenance process, including cleaning and disinfecting the reagents used, single-use components replaced, the calibration and inspection results of the system, etc. This operating record is essential for controlling bioreactor usage and quality.
Post-Maintenance:
After the maintenance work, ensure that the sterile environment is maintained, and close and seal all containers and pipelines. Only bioreactors that meet the sterility and safety requirements can be used for subsequent cell culture or fermentation activities.
Since they are economical and versatile, single-use bioreactors can be utilized in a number of industries and application areas.
Pharmaceutical Sector
Single-use bioreactors are primarily used for cell expansion and for the production of antibodies, enzymes, hormones and therapeutic proteins. They offer a secure and sterile environment for growing cells used in vaccine manufacturing. Moreover, they are applied in the development and production of biologics, which include monoclonal antibodies, recombinant proteins and cell and gene therapies.
Biopharmaceutical Development and Manufacturing
Single-use bioreactors are widely used in biopharmaceuticals' development and already have replaced traditional systems in some areas of the biopharmaceutical industry. They are utilized in cell culture and fermentation processes and enable the scaling up of production quickly and efficiently.
Medical Device industry
In the Medical Device industry, the single-use bioreactor is applied to enzymatic and microbial assays. Microbial and enzymatic assays for the evaluation of materials, products, and processes typically include the use of single-use reactors to house the microorganisms or enzymes involved in the assay.
Tissue Engineering and Regenerative Medicine
In tissue engineering, single-use bioreactors support the growth of stem and primary cells as well as differentiated cell lines. They enable the development of cellular scaffolds and the production of tissue-engineered constructs for regenerative medicine applications.
Food and Beverage Industry
Single-use bioreactors are used to grow microbial cultures, yeasts, and probiotics in the food and beverage industry. They enable the fermentation of food products, beverages like beer and wine. The reactors also allow for the production of food additives, flavor compounds, and nutritional products like probiotics.
Environmental Applications
Single-use bioreactors are commonly used for the treatment of waste and effluents. They provide a controlled environment for microbial communities to degrade pollutants and organic matter in industrial waste streams. Single-use bioreactors are also employed for bioremediation purposes, wherein they support the growth of specific microbes to remediate contaminated soil and water resources.
When choosing a single-use bioreactor, several factors need to be considered for optimal performance, compliance, and operational efficiency.
System scale and size:
Determine the necessary bioreactor capacity. Factors like initial cell culture volume, potential scaling-up requirements, and available lab or facility space will influence the suitable bioreactor size.
Design and configuration:
Consider bioreactor types for the intended application and organism. Also, assess the bioreactor's design features, such as its mixing mechanism, gas exchange system, temperature control options, and pH and dissolved oxygen control capabilities.
Materials compatibility:
The materials used in the bioreactor should be compatible with the organisms and products involved in the process. Evaluate the chemical and thermal resistance of the materials to avoid any adverse reactions or leaching that could affect the culture's integrity.
Integration and automation:
Consider the bioreactor's integration and automation capabilities. Single-use bioreactors should easily connect with other automated systems, such as sampling, feeding, and harvesting systems, to streamline workflows and minimize manual interventions.
Quality and certification:
Ensure that the bioreactor selected meets relevant quality standards and is manufactured with bioprocessing in mind. Single-use bioreactors should be provided with documentation demonstrating compliance with established quality control systems.
Q1: Can single-use bioreactors be reused after cleaning?
A1: Single-use bioreactors are designed for a one-time use only. They cannot be cleaned and reused like traditional bioreactors.
Q2: What type of materials are used for the disposable bags in single-use bioreactors?
A2: The disposable bags are typically made from high-quality, sterile, and biocompatible materials like PETG, film composites, or FEP to ensure product integrity and ease of use.
Q3: Are single-use bioreactors environmentally friendly?
A3: While single-use bioreactors generate more waste than single-use, many manufacturers are working to make their products recyclable or biodegradable.
Q4: What is the biggest single-use bioreactor?
A4: The biggest single-use bioreactor is the ""NBS"" (N-1 Bioreactor) from ""Intrexon"" that can produce up to 10,000 liters of cell culture.
