Manufacturing of recombinant therapeutic proteins in microbial systems

Graumann, Klaus; Premstaller, Andreas

doi:10.1002/biot.200500051

Cited by 164 publications

(103 citation statements)

References 294 publications

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“…Culture Growth Parameters. Dissolved oxygen (DO) or partial oxygen pressure, pH, and temperature are among the most relevant physiological parameters for a fermentation process (Cereghino et al, 2002;Graumann and Premstaller, 2006). This study characterizes their effect on growth kinetics during the batch and fed-batch growth phases of the fermentation process.…”

Section: Resultsmentioning

confidence: 99%

Defining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation

Harms

Wang

Kim

et al. 2008

Biotechnology Progress

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The concept of "design space" has been proposed in the ICH Q8 guideline and is gaining momentum in its application in the biotech industry. It has been defined as "the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality." This paper presents a stepwise approach for defining process design space for a biologic product. A case study, involving P. pastoris fermentation, is presented to facilitate this. First, risk analysis Via Failure Modes and Effects Analysis (FMEA) is performed to identify parameters for process characterization. Second, small-scale models are created and qualified prior to their use in these experimental studies. Third, studies are designed using Design of Experiments (DOE) in order for the data to be amenable for use in defining the process design space. Fourth, the studies are executed and the results analyzed for decisions on the criticality of the parameters as well as on establishing process design space. For the application under consideration, it is shown that the fermentation unit operation is very robust with a wide design space and no critical operating parameters. The approach presented here is not specific to the illustrated case study. It can be extended to other biotech unit operations and processes that can be scaled down and characterized at small scale.

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Section: Resultsmentioning

confidence: 99%

Defining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation

Harms

Wang

Kim

et al. 2008

Biotechnology Progress

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“…Escherichia coli and yeast are among the most widely used systems for the production of recombinant proteins (22)(23)(24), and bioinformatics has facilitated the production of a variety of recombinant proteins that have been investigated as Leishmania vaccine antigen candidates in animal models (15,20). Key to the use of recombinant proteins is the cost-effectiveness of production, an important consideration when modeling has shown that a cost of $2 or less per dose for a preventive vaccine would be economically advantageous over the currently available leishmaniasis treatments (25).…”

Section: Purified Recombinant Proteinsmentioning

confidence: 99%

Not All Antigens Are Created Equally: Progress, Challenges, and Lessons Associated with Developing a Vaccine for Leishmaniasis

Duthie

Reed

2017

Clin Vaccine Immunol

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From experimental models and the analyses of patients, it is well documented that antigen-specific T cells are critical for protection against Leishmania infection. Effective vaccines require both targeting to the pathogen and an immune stimulant to induce maturation of appropriate immune responses. While a great number of antigens have been examined as vaccine candidates against various Leishmania species, few have advanced to human or canine clinical trials. With emphasis on antigen expression, in this minireview we discuss some of the vaccine platforms that are currently being explored for the development of Leishmania vaccines. It is clear that the vaccine platform of choice can have a significant impact upon the level of protection induced by particular antigens, and we provide and highlight some examples for which the vaccine system used has impacted the protective efficacy imparted.

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“…Plants can be used as bioreactors for large scale production of therapeutic antibodies at a low cost [40,41]. Significant progress has been made in the expression of mAbs in plants.…”

Section: Manufacturing Costmentioning

confidence: 99%

Opportunities and Challenges of Therapeutic Monoclonal Antibodies as Medical Countermeasures for Biodefense

Hu¹,

Nagata²

2016

J Bioterror Biodef

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Antibodies, naturally produced in the body as part of the immune response to infectious agents, can also be introduced artificially to treat infectious diseases. Advances in biotechnology in the last decades have made human or humanized monoclonal antibodies (mAbs) as therapeutics possible. These therapeutic mAbs currently enjoy unprecedented success and recognition of their potential. Unlike vaccines, therapeutic mAbs can confer instant and consistent protection against bio-threat agents when administered regardless of the recipient's immune status. Therapeutic mAbs can be administered in higher levels than those elicited by vaccines, and thus provide a higher level of protection or treatment that is necessary in a biological attack where people are exposed to a higher exposure of agent concentration than that found in nature. Furthermore, therapeutic mAbs have substantial advantages over antimicrobial drugs, such as high specificity, low systemic toxicity, relatively long half-life, and no concerns over disrupting the body's microbiome. Therapeutic mAbs can be used for both pre-and post-exposure protection; therefore, they have great value as effective medical countermeasures (MedCMs) against bio-threat agents. However, there are still some challenges to be overcome before therapeutic mAbs become ideal MedCMs against bio-threat agents. In this review, both opportunities and challenges in development of therapeutic mAbs are discussed.

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Manufacturing of recombinant therapeutic proteins in microbial systems

Cited by 164 publications

References 294 publications

Defining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation

Defining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation

Not All Antigens Are Created Equally: Progress, Challenges, and Lessons Associated with Developing a Vaccine for Leishmaniasis

Opportunities and Challenges of Therapeutic Monoclonal Antibodies as Medical Countermeasures for Biodefense

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