Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(1).8-9
Kaijian Hou
Shantou traditional Chinese medical hospital, China Little atom drugs have been the pillar of the drug business for almost a century. Characterized as any natural compound with low atomic weight, little particle drugs have some unmistakable benefits as therapeutics: most can be regulated orally and they can go through cell films to arrive at intracellular targets. They can likewise be intended to draw in natural focuses by different methods of activity and their dissemination can additionally be custom-made, for instance to consider foundational openness with or without cerebrum infiltration.
{"title":"Short Commentary on Pharmaceutical Bioprocessing","authors":"Kaijian Hou","doi":"10.37532/2048-9145.2021.9(1).8-9","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(1).8-9","url":null,"abstract":"Shantou traditional Chinese medical hospital, China Little atom drugs have been the pillar of the drug business for almost a century. Characterized as any natural compound with low atomic weight, little particle drugs have some unmistakable benefits as therapeutics: most can be regulated orally and they can go through cell films to arrive at intracellular targets. They can likewise be intended to draw in natural focuses by different methods of activity and their dissemination can additionally be custom-made, for instance to consider foundational openness with or without cerebrum infiltration.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"62 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69923908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(1).6-7
Binfeng Yuan
{"title":"Current Research on Pharmaceutical Bioprocessing","authors":"Binfeng Yuan","doi":"10.37532/2048-9145.2021.9(1).6-7","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(1).6-7","url":null,"abstract":"","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(3).22-23
A. Gr, As
Pharmaceutical Bioprocessing is a peer-reviewed journal addressing all issues relating to bioprocessing in the development and manufacture of healthcare products.International Journal of Bioprocessing and Biotechniques aim is to make on-going research work and study available for all readers, as a platform and source for the scientists, research scholars, students and other healthcare practitioners in the fields of bioengineering, biomedical engineering, bio manufacturing, molecular engineering, food processing. A bioreactor alludes to any produced gadget or framework that bolsters an organically dynamic environment. In one case, a bioreactor is a vessel where a compound cycle is completed which includes creatures or biochemically dynamic substances got from such living beings. This cycle can either be high-impact or anaerobic. These bioreactors are ordinarily round and hollow, going in size from litres to cubic meters, and are regularly made of pure steel. It might likewise allude to a gadget or framework intended to develop cells or tissues with regards to cell culture. These gadgets are being produced for use in tissue designing or biochemical/bioprocess engineering.
{"title":"Pharmaceutical Process and Design ofNovel Drugs","authors":"A. Gr, As","doi":"10.37532/2048-9145.2021.9(3).22-23","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(3).22-23","url":null,"abstract":"Pharmaceutical Bioprocessing is a peer-reviewed journal addressing all issues relating to bioprocessing in the development and manufacture of healthcare products.International Journal of Bioprocessing and Biotechniques aim is to make on-going research work and study available for all readers, as a platform and source for the scientists, research scholars, students and other healthcare practitioners in the fields of bioengineering, biomedical engineering, bio manufacturing, molecular engineering, food processing. A bioreactor alludes to any produced gadget or framework that bolsters an organically dynamic environment. In one case, a bioreactor is a vessel where a compound cycle is completed which includes creatures or biochemically dynamic substances got from such living beings. This cycle can either be high-impact or anaerobic. These bioreactors are ordinarily round and hollow, going in size from litres to cubic meters, and are regularly made of pure steel. It might likewise allude to a gadget or framework intended to develop cells or tissues with regards to cell culture. These gadgets are being produced for use in tissue designing or biochemical/bioprocess engineering.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(3).E28
I. Taraporewala
Industrial animal cell culture is used to make many life-saving biopharmaceutical proteins, vaccines and cell therapies. Contamination of an industrial animal cell culture with a microorganism, such as a bacteria or virus, may occur through many means, for example, human error, inadequate aseptic protocols within biosafety level 2 (BSL-2) cabinets, failure of a processing step such as steam sterilization, loss of equipment integrity such as a crack in a disposable bioreactor, and/or introduction of a new adventitious agent not susceptible to current removal or inactivation procedures.The term microorganism is synonymous with the common term microbe (adjective microbial). In response to such contamination crises, many firms simultaneously implemented a large number of changes, in emergency mode, without first identifying the source of the problem or thus understanding the likely effectiveness of any given change. Over time, one key change or two typically solved the problem. Sometimes the source of the problem, as well as the key change(s) that actually solved the problem, were identified. Other times, no such clear identifications were made. In nearly all cases, the whole slew of changes were carried forward, even though some were likely ineffective, as well as a waste of time, money and focus. Yet many people in developing countries who could benefit from pharmaceuticals do not receive them. The failure of antiretroviral therapy to reach more than a tiny fraction of people with AIDS in developing countries has attracted widespread publicity, but even medicines that are far cheaper and easier to deliver are not reaching many of the people who need them. More than a quarter of children worldwide and over half of children in some countries do not receive the vaccines that are part of WHO’s Expanded Program on Immunization, although these cost only pennies per dose and require no diagnosis. Three million lives are lost annually as a result (World Bank, 2001a). Only a small fraction of children in poor countries receive the newer hepatitis B and Haemophilus influenzae b (Hib) vaccines, which cost a dollar or two per dose. One in four people worldwide suffer from intestinal worms, although treatments only need to be taken once or twice per year, have virtually no side effects, and cost less than a dollar per year. When asked which viral barriers proved impractical, company representatives had mixed responses. Filtration was characterized by some as expensive, having poor flux properties, or not suitable for use with bulk medium as some important media components were filtered out. Conversely, many interviewees stated that filtration was quite practical for small volumes, including heat-sensitive supplements, as well as hydrophobic additions. While certain respondents described HTST as quite practical and cost effective, others described it as ineffective due to cost, the large space it takes in the plant, and incompatibility with serum and hydrolys
{"title":"Bioproduction of Pharmaceuticalsbioprocess and the Developing World","authors":"I. Taraporewala","doi":"10.37532/2048-9145.2021.9(3).E28","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(3).E28","url":null,"abstract":"Industrial animal cell culture is used to make many life-saving biopharmaceutical proteins, vaccines and cell therapies. Contamination of an industrial animal cell culture with a microorganism, such as a bacteria or virus, may occur through many means, for example, human error, inadequate aseptic protocols within biosafety level 2 (BSL-2) cabinets, failure of a processing step such as steam sterilization, loss of equipment integrity such as a crack in a disposable bioreactor, and/or introduction of a new adventitious agent not susceptible to current removal or inactivation procedures.The term microorganism is synonymous with the common term microbe (adjective microbial). In response to such contamination crises, many firms simultaneously implemented a large number of changes, in emergency mode, without first identifying the source of the problem or thus understanding the likely effectiveness of any given change. Over time, one key change or two typically solved the problem. Sometimes the source of the problem, as well as the key change(s) that actually solved the problem, were identified. Other times, no such clear identifications were made. In nearly all cases, the whole slew of changes were carried forward, even though some were likely ineffective, as well as a waste of time, money and focus. Yet many people in developing countries who could benefit from pharmaceuticals do not receive them. The failure of antiretroviral therapy to reach more than a tiny fraction of people with AIDS in developing countries has attracted widespread publicity, but even medicines that are far cheaper and easier to deliver are not reaching many of the people who need them. More than a quarter of children worldwide and over half of children in some countries do not receive the vaccines that are part of WHO’s Expanded Program on Immunization, although these cost only pennies per dose and require no diagnosis. Three million lives are lost annually as a result (World Bank, 2001a). Only a small fraction of children in poor countries receive the newer hepatitis B and Haemophilus influenzae b (Hib) vaccines, which cost a dollar or two per dose. One in four people worldwide suffer from intestinal worms, although treatments only need to be taken once or twice per year, have virtually no side effects, and cost less than a dollar per year. When asked which viral barriers proved impractical, company representatives had mixed responses. Filtration was characterized by some as expensive, having poor flux properties, or not suitable for use with bulk medium as some important media components were filtered out. Conversely, many interviewees stated that filtration was quite practical for small volumes, including heat-sensitive supplements, as well as hydrophobic additions. While certain respondents described HTST as quite practical and cost effective, others described it as ineffective due to cost, the large space it takes in the plant, and incompatibility with serum and hydrolys","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(3).26-27
C. PerryChou
In 2005, the American Chemical Society (ACS) Green Chemistry Institute (GCI) and global pharmaceutical companies established the ACS GCI Pharmaceutical Roundtable to encourage the integration of green chemistry and engineering into the pharmaceutical industry. The Roundtable developed a list of key research areas in green chemistry in 2007, which has served as a guide for focusing green chemistry research. Following that publication, the Roundtable companies have identified a list of the key green engineering research areas that is intended to be the required companion of the first list. Intense efforts in bioprocessing development have been made to improve the production of Chinese hamster ovary-based biopharmaceuticals. However, lacking an efficient host cell has hampered therapeutic protein production. This article reviews means by which biopharmaceutical production can be improved via cell engineering. Finally, rational cell engineering facilitated with ‘omics technologies is presented.
{"title":"Developing an Free Bioprocess toProduce Pharmaceutical Quality Grade","authors":"C. PerryChou","doi":"10.37532/2048-9145.2021.9(3).26-27","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(3).26-27","url":null,"abstract":"In 2005, the American Chemical Society (ACS) Green Chemistry Institute (GCI) and global pharmaceutical companies established the ACS GCI Pharmaceutical Roundtable to encourage the integration of green chemistry and engineering into the pharmaceutical industry. The Roundtable developed a list of key research areas in green chemistry in 2007, which has served as a guide for focusing green chemistry research. Following that publication, the Roundtable companies have identified a list of the key green engineering research areas that is intended to be the required companion of the first list. Intense efforts in bioprocessing development have been made to improve the production of Chinese hamster ovary-based biopharmaceuticals. However, lacking an efficient host cell has hampered therapeutic protein production. This article reviews means by which biopharmaceutical production can be improved via cell engineering. Finally, rational cell engineering facilitated with ‘omics technologies is presented.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(1).2-3
M. Al-Rubeai
{"title":"Bioresources and Bioprocessing a review","authors":"M. Al-Rubeai","doi":"10.37532/2048-9145.2021.9(1).2-3","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(1).2-3","url":null,"abstract":"","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69923778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(1).4-5
S. Gavanji
{"title":"Research on Pharmaceutical Bioprocessing a short communication","authors":"S. Gavanji","doi":"10.37532/2048-9145.2021.9(1).4-5","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(1).4-5","url":null,"abstract":"","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(3).24-25
S. Timur
The use of spectroscopic sensors for bioprocess monitoring is a powerful tool within the process analytical technology (PAT) initiative of the US Food and Drug Administration. Spectroscopic sensors enable the simultaneous real-time bioprocess monitoring of various critical process parameters including biological, chemical, and physical variables during the entire biotechnological production process. Approximately 30 ago, when modern biotechnology provided biological like Nobelmedaled monoclonal antibodies and more for the first time this innovative technology boosted pharm a’s pipeline of drug candidates. However, the low-hanging fruits were early gathered and another disruptive innovation is not in sight. What is often described as the so-called innovation gap gets even worse when looking at the remaining patent terms of the drugs on the market. It becomes shorter and shorter and it is foreseeable that the pipeline of new NCE patents will not balance the loss. On the other hand, this development pushes the market for generics, which in the USA, is believed to exceed $81.5 billion with an impressive projected annual growth rate of approximately 10% for 2011–2013. Consequently, the valuation of big pharm companies is falling in an alarming way. According to Burrell& Company, the 17 most relevant players are valued at only $1 trillion today, compared with $1.6 trillion in 2000. Single-use bioreactors are commonly used in the biopharmaceutical industry today; however, they are mostly limited to mammalian cell culture processes. For microbial processes, concepts including the CELL-tainer® technology provide comparable oxygen mass transfer such as in stirred tank reactors. this type of single-use bioreactor is applicable in biopharmaceutical processes, and also in a seed train for bulk chemicals production such as amino acid production. It is expected that single-use technologies will be applied ever more frequently in microbial-fed batch cultivation processes in combination with improved monitoring and control. Bioprocess and biocatalyst IP developed for small-volume/high value pharmaceutical production will therefore find another even bigger market in bulk volume/ lower value processes. Therefore, today’s financing climate for R&D targeting production processes is very different to the early days of biopharmaceuticals. For example, the development of genome sequencing has been financed at first by pharmaceutical industry investors and related industries. Later, such technologies were used by the chemical industry in their desire for modern biotechnological processes, without ever contributing to the basic cost of development. The controversy over intellectual property rights for pharmaceuticals and access to antiretroviral therapies in developing countries has been the subject of much public debate recently. This article provides a broader context for the debate. It first reviews characteristics of the developing country market for pharmaceutical
{"title":"Biography of PharmaceuticalBioprocesses","authors":"S. Timur","doi":"10.37532/2048-9145.2021.9(3).24-25","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(3).24-25","url":null,"abstract":"The use of spectroscopic sensors for bioprocess monitoring is a powerful tool within the process analytical technology (PAT) initiative of the US Food and Drug Administration. Spectroscopic sensors enable the simultaneous real-time bioprocess monitoring of various critical process parameters including biological, chemical, and physical variables during the entire biotechnological production process. Approximately 30 ago, when modern biotechnology provided biological like Nobelmedaled monoclonal antibodies and more for the first time this innovative technology boosted pharm a’s pipeline of drug candidates. However, the low-hanging fruits were early gathered and another disruptive innovation is not in sight. What is often described as the so-called innovation gap gets even worse when looking at the remaining patent terms of the drugs on the market. It becomes shorter and shorter and it is foreseeable that the pipeline of new NCE patents will not balance the loss. On the other hand, this development pushes the market for generics, which in the USA, is believed to exceed $81.5 billion with an impressive projected annual growth rate of approximately 10% for 2011–2013. Consequently, the valuation of big pharm companies is falling in an alarming way. According to Burrell& Company, the 17 most relevant players are valued at only $1 trillion today, compared with $1.6 trillion in 2000. Single-use bioreactors are commonly used in the biopharmaceutical industry today; however, they are mostly limited to mammalian cell culture processes. For microbial processes, concepts including the CELL-tainer® technology provide comparable oxygen mass transfer such as in stirred tank reactors. this type of single-use bioreactor is applicable in biopharmaceutical processes, and also in a seed train for bulk chemicals production such as amino acid production. It is expected that single-use technologies will be applied ever more frequently in microbial-fed batch cultivation processes in combination with improved monitoring and control. Bioprocess and biocatalyst IP developed for small-volume/high value pharmaceutical production will therefore find another even bigger market in bulk volume/ lower value processes. Therefore, today’s financing climate for R&D targeting production processes is very different to the early days of biopharmaceuticals. For example, the development of genome sequencing has been financed at first by pharmaceutical industry investors and related industries. Later, such technologies were used by the chemical industry in their desire for modern biotechnological processes, without ever contributing to the basic cost of development. The controversy over intellectual property rights for pharmaceuticals and access to antiretroviral therapies in developing countries has been the subject of much public debate recently. This article provides a broader context for the debate. It first reviews characteristics of the developing country market for pharmaceutical","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.37532/2048-9145.2021.9(3).20-21
S. Gavanji
The use of biopharmaceuticals dates from the 19th century and within 5–10 years, up to 50% of all drugs in development will be biopharmaceuticals. In the 1980s, the biopharmaceutical industry experienced significant growth in the production and approval of recombinant proteins such as interferon’s (IFN α, β, and γ) and growth hormones. The production of biopharmaceuticals, known as bioprocess, involves a wide range of techniques.
{"title":"Dynamics and scale-up of thePharmaceutical molecule","authors":"S. Gavanji","doi":"10.37532/2048-9145.2021.9(3).20-21","DOIUrl":"https://doi.org/10.37532/2048-9145.2021.9(3).20-21","url":null,"abstract":"The use of biopharmaceuticals dates from the 19th century and within 5–10 years, up to 50% of all drugs in development will be biopharmaceuticals. In the 1980s, the biopharmaceutical industry experienced significant growth in the production and approval of recombinant proteins such as interferon’s (IFN α, β, and γ) and growth hormones. The production of biopharmaceuticals, known as bioprocess, involves a wide range of techniques.","PeriodicalId":90285,"journal":{"name":"Pharmaceutical bioprocessing","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69924089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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