What Are Different Stages in A Bioprocess

Introduction

Bioprocesses are complex series of steps that are carried out to produce biologically derived products or to make use of biological reactions for specific applications. These processes typically involve the use of living cells, enzymes, or other biological molecules to catalyze or carry out chemical reactions.

Bioprocesses can be found in many different fields, including medicine, agriculture, biotechnology, and environmental science. They are often used to produce drugs, vaccines, food additives, biofuels, and other products that are important for human health and welfare.

The article below gives us a closer look at typical bioprocess, from initial research and development to final product purification and quality control.

Stage 1: Research and Development

The first stage in a bioprocess is research and development, which involves identifying the target molecule or product and developing a process to produce it.

This stage can involve a range of activities, including −

Identifying The Target Molecule or Product

The first step in any bioprocess is to identify the molecule or product that is desired. This can involve screening natural sources for potential candidates or designing molecules from scratch using computational tools.

Developing a Production Process

Once a target molecule has been identified, the next step is to develop a production process to make it. This involves selecting the appropriate cells or enzymes to use, optimizing growth conditions, and designing a process that is scalable and cost-effective.

Establishing Proof of Concept

Before moving on to large-scale production, it is important to establish proof of concept for the bioprocess. This can involve testing the process in small-scale trials to determine its feasibility and optimize the production conditions.

Stage 2: Upstream Processing

Once the research and development stage is complete, the bioprocess moves into upstream processing. This stage involves preparing the biological material that will be used to produce the target molecule.

The main activities in upstream processing include −

Cell or Microorganism Culture

For many bioprocesses, the target molecule is produced by living cells or microorganisms. These cells need to be grown in culture under controlled conditions to ensure that they produce the desired product. This involves selecting the appropriate growth media, temperature, and pH conditions, as well as monitoring cell growth and viability

Fermentation or Bioreactor Operation

In many cases, the cells or microorganisms used in a bio process are grown in large-scale fermenters or bioreactors. These vessels provide the optimal conditions for cell growth and product production and allow for precise control of growth parameters such as temperature, pH, and oxygen levels.

Harvesting

Once the cells or microorganisms have produced the target molecule, they need to be harvested from the culture medium. This typically involves separating the cells from the medium using techniques such as centrifugation or filtration.

Stage 3: Downstream Processing

After the upstream processing stage, the bioprocess moves into downstream processing. This stage involves separating and purifying the target molecule from the other components in the culture medium.

The main activities in downstream processing include −

Cell Lysis or Disruption

For many bioprocesses, the target molecule is contained within the cells or microorganisms that were used to produce it. These cells need to be lysed or disrupted to release the product. This can involve mechanical methods such as sonication or chemical methods such as detergents.

Filtration

Once the cells or microorganisms have been lysed or disrupted, the resulting mixture needs to be filtered to remove cell debris and other impurities. This can be done using techniques such as microfiltration, ultrafiltration, or diafiltration.

Chromatography

Chromatography is a technique used to separate and purify molecules based on their physical and chemical properties. In bioprocesses, chromatography is often used to separate the target molecule from other components in the mixture. There are several types of chromatography, including affinity chromatography, ion exchange chromatography, and size exclusion chromatography.

Concentration

Once the target molecule has been separated and purified, it needs to be concentrated to increase its potency and reduce the volume of the final product. This can be done using techniques such as ultrafiltration or evaporation.

Formulation

After concentration, the target molecule is typically formulated into a final product that is suitable for use. This can involve adding stabilizers, preservatives, or other additives to ensure the product remains stable and effective over time.

Stage 4: Quality Control

The final stage in a bioprocess is quality control, which involves testing the final product to ensure it meets the required specifications for purity, potency, and safety. The main activities in quality control include −

Analytical Testing

Analytical testing is used to measure the purity and potency of the target molecule. This can involve techniques such as high-performance liquid chromatography (HPLC), mass spectrometry, or enzyme-linked immunosorbent assay (ELISA).

Microbiological Testing

Microbiological testing is used to ensure that the final product is free from harmful microorganisms such as bacteria, viruses, or fungi. This can involve techniques such as microbial culture, PCR, or immunoassay.

Stability Testing

Stability testing is used to determine the shelf life of the final product and ensure it remains stable and effective over time. This can involve exposing the product to different environmental conditions such as temperature, humidity, or light, and measuring changes in its potency or purity over time.

Regulatory Compliance

Finally, the bioprocess must comply with regulatory requirements for safety and efficacy. This can involve submitting the product for review by regulatory agencies such as the FDA or EMA and ensuring that the production process meets established quality standards such as Good Manufacturing Practices (GMP).

Conclusion

Bioprocesses are complex, multi-stage processes that involve a range of different activities, from research and development to final product purification and quality control.

While each bioprocess is unique, they all follow a similar basic framework of upstream processing, downstream processing, and quality control.

By understanding the different stages in a bioprocess and the techniques used to carry out each stage, researchers and scientists can develop new and more effective processes for producing biologically derived products that are essential for human health and welfare.