Mini Review - Pharmaceutical Bioprocessing (2023) Volume 11, Issue 2

Recombinant Protein Bioprocessing

Bonnie David*

School of Chemical Engineering, Birmingham, UK

*Corresponding Author:
Bonnie David
School of Chemical Engineering, Birmingham, UK

Received: 02-Mar-2023, Manuscript No. FMBP-23-92383; Editor assigned: 04-Mar-2023, PreQC No. FMBP-23-92383 (PQ); Reviewed: 18-Mar-2023, QC No FMBP-23-92383; Revised: 23-Mar-2023, Manuscript No. FMBP-23-92383 (R); Published: 30-Mar-2023, DOI: 10.37532/2048-9145.2023.11(2).19-21


Recombinant protein synthesis is essential for both the discovery of novel protein therapeutics and the structural identification of pharmacological targets. Recombinant protein manufacturing therefore plays a significant part in the creation of pharmaceuticals. Around 30% of the biopharmaceuticals now available on the market are produced using recombinant proteins that are frequently produced on bacterial hosts. I outline key ideas in this review related to the creation of drugs and production scales for recombinant proteins in bacteria. How can this failure be minimised to quickly give maximal quantities of high-quality protein and so speed up drug discovery? Recombinant protein manufacturing systems frequently experience failure.


Protein Expression • Process development • Upstream processing • Downstream processing • Integrated continuous bioprocessing


One of the basic requirements of humanity is the mass manufacturing of therapeutic proteins for the treatment of diseases in millions of people. Recombinant proteins that can be utilised as medicines, vaccines, and diagnostic tools are now possible because to recent advancements in recombinant DNA technologies. Recombinant proteins are typically created for these uses in both large- and small-scale settings employing prokaryotic and eukaryotic expression host systems, such as mammalian cells, bacteria, yeast, insect cells, and transgenic plants. The industrial synthesis of recombinant proteins that are important for therapeutic and preventative purposes depends on the development of effective bioprocessing techniques. Current developments in the various fields of bioprocessing are being used to provide efficient methods for creating recombinant proteins. These include the use of disposable systems, continuous upstream processing, continuous chromatography, integrated continuous bioprocessing, Quality by Design, and process analytical technologies to produce quality products with higher yield. They also include the use of high-throughput devices for effective bioprocess optimization. This study outlines recent advancements in recombinant protein bioprocessing, including different expression systems, bioprocess development, and recombinant protein upstream and downstream processing [1-5].

Chemical engineering’s industrial bioprocessing specialty focuses on planning, developing, and producing products for agriculture, feed, food, and polymers in biological waste water treatment. Spectrum design for bioreactors is also covered in industrial bioprocessing publications. In order to create and enhance diverse chemicals and pharmaceutical medications, industrial bioprocessing offers us cutting-edge sources and knowledge about industrial processing connected to the bioprocessing domains. It also gives us the most recent R&D information. Chemical engineering’s industrial bioprocessing specialty focuses on planning, developing, and producing products for agriculture, feed, food, and polymers in biological waste water treatment. Spectrum design for bioreactors is also covered in industrial bioprocessing publications.

The development of sustainable chemical production utilising renewable crop-based feedstocks has taken both economic and environmental factors into account. In contrast to fossil fuels and petrochemicals, biomass is a readily available, renewable source of carbon-neutral feedstock for the manufacture of fuels and chemicals. Integrated bio-refining, which separates highvalue nutritional products while using the main feedstock component for biofuel and chemical production, and further convert’s low-value by-products into additional marketable products such as animal feed and energy, can help first-generation bio-refineries, which use corn, soybeans, and sugarcane for the production of bioethanol and biodiesel. Agricultural and forestry leftovers, as well as lignocellulosic biomass, are used in second-generation bio-refineries, which offer the chance to supply a sizable amount of the world’s fuel and chemical needs. Aquacultures of either microalgae or macro algae, which rely on sunshine and CO2 for growth, are used in third-generation bio-refineries to provide all of the world’s future fuel demands without interfering with the land’s existing agricultural use. As new energy crops, aquaculture, synthetic biology for cell engineering, and conversion technologies continue to advance and improve, bio-refining will play a bigger part in providing energy, fuel, and chemicals to sustain economic growth without having a significant negative impact on the environment. Yet, the bio-refinery business also faces a lot of difficulties. Because of the complicated structure of the feedstock and the high costs of pre-treatment and enzymatic cellulose hydrolysis, lignocellulosic refining is not yet rationally cost-effective. Even though a number of novel cellulosic biomass bioprocesses have been industrialised, it is obvious that many technological and economic obstacles still need to be overcome before the full promise of this field can be realised. However, it is challenging to scale up procedures that use microalgae with photosynthesis for cell development and oil production. These processes are also not at all cost-effective. New developments in process engineering and metabolic engineering for biomass conversion will be necessary to produce biofuels and bio-based compounds in an environmentally friendly and economically feasible manner. To maximise product values, reduce waste generation, and improve process economics, a bio-refinery should use all of a given biomass feedstock’s components to produce fuels, chemicals, and energy. To do this, a combination of technologies from various fields is required, including new energy crops with higher biomass yields, improved and affordable enzymes for hydrolysis, innovative and upgraded cells, and upgraded catalysts for biomass conversion to chemical energy sources [6-10].


Bioprocessing refers to the utilisation of whole living cells or parts of them (such as bacteria, enzymes, or chloroplasts) to produce desired products. Additionally, the manufacture of therapeutic stem cells, gene therapy vectors, and novel vaccines, as well as the development of renewable biofuels like ethanol and biodiesel, all depend on bioprocessing. The biotech business is subject to strict rules from the Food and Drug Administration; this highly regulated environment has a significant impact on factory operations and product production. In bioprocessing, a living thing—typically cells or cell components, viruses, or a full organism—is used to produce valuable goods. Final products can range from biofuels made from algae to medicines like penicillin made from mould. Another example of bioprocessing is the production of beer using yeast. Given the variety of bioprocessing uses and the intricate nature of the stages involved, experts in chemistry, biochemistry, biology, microbiology, and chemical engineering are needed in this subject.

A promising production method for the coming era has been predicted to be bioprocessing. The methods have, however, run into a number of problems, most notably cost inefficiency. Process integration has been recommended to boost process economy and has been thoroughly researched to address this problem. This article presents the conceptual framework for process integration and categorises integration techniques in light of the development of bioprocesses. It is discussed how to successfully combine membrane technology with traditional separation methods like extraction, adsorption, etc. and bioreactors. There are also some suggestions for integrating biotechnological principles.


Recombinant therapeutic protein production is a time-consuming, expensive, and multidisciplinary procedure. Recombinant proteins are increasingly in demand for use in human applications. There is a big market for innovative and enhanced bioprocessing methods that are time and money efficient. The manufacture of high-quality products has been made possible by the ongoing development of biopharmaceutical expression systems. The generation of therapeutic proteins using diverse prokaryote or eukaryote expression systems is at the forefront of modern molecular biology techniques. To enhance the efficiency of bioprocesses and produce biologically active and stable proteins, strain engineering can be used in conjunction with a number of cuttingedge approaches, including systems biology, metabolic engineering, and CRISPR/Cas systems. Strategies for glycol-engineering may make it simple to produce a therapeutic protein with increased biological activity and safety. Continuous bioprocessing, single-use systems, and HTPD are seen to be extremely significant advancements. Single-use systems are being utilised more frequently in the construction of both upstream and downstream processes, boosting flexibility and output rate while lowering capital costs and downtime. Despite significant advancements in single-use systems and integrated continuous biomanufacturing, a number of components still require improvement, such as the blending of hardware and software. The development of continuous bioprocessing, as shown in applications like continuous chromatography and viral inactivation, would also benefit from the use of really continuous separation technologies rather than semicontinuous ones. Continuous bioprocessing could save capital and labour costs, as well as the footprint of facilities and equipment used in the manufacturing of biopharmaceuticals. Even while continuous bioprocessing has seen numerous advances, fully synchronised upstream and downstream processing is still lacking. A fully end-to-end continuous integrated bioprocess for biopharmaceuticals will be realised through a well-balanced and methodical approach to continuous upstream and continuous downstream processing, coupled with process and product characterization. The methods used to ensure the medicines’ quality are always changing. Regulatory agencies advise the QBD technique for a consistent process and higher-quality protein manufacturing. The success of bioprocessing and compliance with regulatory requirements will be significantly impacted by the use of advanced process analytical technology for direct and real-time analysis of critical product quality attributes like product concentration and contaminants during the operation and at discharge.


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