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Advanced Search Results For "Biosimilars and biotherapeutics"

1 - 10 of 2,578 results for
 "Biosimilars and biotherapeutics"
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Comparing the original and biosimilar biotherapeutics of the monoclonal antibody eculizumab by intact mass measurement and middle-up mass spectrometry analysis

Publication Type:Academic Journal

Source(s):Тонкие химические технологии, Vol 16, Iss 1, Pp 76-87 (2021)

Abstract:Objectives. In this biosimilar research, we compare the monoclonal antibody eculizumab obtained from different drugs [original Soliris® (Alexion Pharmaceuticals) and candidate Elizaria® (Generium)] by intact mass measurement and middle-up mass spectrom...

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Development of biotherapeutics and biosimilars.

Publication Type:Editorial & Opinion

Source(s):Drug discovery today. Technologies [Drug Discov Today Technol] 2021 Dec; Vol. 40, pp. 1-2. Date of Electronic Publication: 2021 Nov 06.

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WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

Publication Type:Academic Journal

Source(s):Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2022 Apr; Vol. 76, pp. 1-9. Date of Electronic Publication: 2022 Apr 22.

Abstract:The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultatio...

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Viral safety for biotherapeutics and biosimilar.

Publication Type:Academic Journal

Source(s):Drug Discovery Today: Technologies; Dec2020, Vol. 37, p23-29, 7p

Abstract:Copyright of Drug Discovery Today: Technologies is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print,...

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Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA

Publication Type:Academic Journal

Source(s):Биопрепараты: Профилактика, диагностика, лечение, Vol 19, Iss 1, Pp 17-27 (2019)

Abstract:European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul...

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Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review.

Publication Type:Academic Journal

Source(s):The AAPS journal [AAPS J] 2021 Dec 20; Vol. 24 (1), pp. 15. Date of Electronic Publication: 2021 Dec 20.

Abstract:The development of monoclonal antibody (mAb) biosimilars is a complex process. The key to their successful development and commercialization is an in-depth understanding of the key product attributes that impact safety and efficacy and the strategies t...

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Enhanced production of recombinant serratiopeptidase in Escherichia coli and its characterization as a potential biosimilar to native biotherapeutic counterpart

Publication Type:Academic Journal

Source(s):Microbial Cell Factories, Vol 18, Iss 1, Pp 1-15 (2019)

Abstract:Abstract Background Serratia marcescens, a Gram-negative nosocomial pathogen secretes a 50 kDa multi-domain zinc metalloprotease called serratiopeptidase. Broad substrate specificity of serratiopeptidase makes it suitable for detergent and food process...

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The Development Pathway for Biosimilar Biotherapeutics

Publication Type:Academic Journal

Source(s):Journal of Ophthalmic & Vision Research, Vol 15, Iss 3, Pp 273-274 (2020)

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The controversy around technical standards for similar biotherapeutics: barriers to access and competition? † .

Publication Type:Academic Journal

Source(s):Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2020 Nov; Vol. 29 (11), pp. 1518-1522. Date of Electronic Publication: 2020 Sep 22.

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Enhanced production of recombinant serratiopeptidase in Escherichia coli and its characterization as a potential biosimilar to native biotherapeutic counterpart.

Publication Type:Academic Journal

Source(s):Microbial cell factories [Microb Cell Fact] 2019 Dec 17; Vol. 18 (1), pp. 215. Date of Electronic Publication: 2019 Dec 17.

Abstract:Background: Serratia marcescens, a Gram-negative nosocomial pathogen secretes a 50 kDa multi-domain zinc metalloprotease called serratiopeptidase. Broad substrate specificity of serratiopeptidase makes it suitable for detergent and food processing indu...

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