Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim

Biologicals : Journal of the International Association of Biological Standardization
A SkrlinS Marinc

Abstract

Recombinant human granulocyte-colony stimulating factor (filgrastim) is a therapeutic protein used primarily to reduce incidence and duration of severe neutropenia and its associated, and serious, complications. We have developed a biosimilar filgrastim (Hospira filgrastim; Nivestim) designed to be comparable to Amgen filgrastim (Neupogen). An extensive characterization study assessed the physiochemical similarity of Hospira filgrastim to Amgen filgrastim. Both drugs were supplied in 1 ml glass, single-use, prefilled syringes (five batches of each product at 480 microg/0.5 ml and one batch of each product at 300 microg/0.5 ml). Samples were evaluated using state-of-the-art analytical methods (validated in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use or Pharmeuropa guidelines) to determine physicochemical properties, molecular characteristics, purity and biological activity. Samples were compared after long-term storage at 2-8 degrees C and storage at 40 degrees C (stress conditions) to evaluate their degradation impurity profiles. Hospira filgrastim and Amgen filgrastim were shown to have similar physicochemical properties, molecular charac...Continue Reading

References

Jan 1, 1989·Archives of Biochemistry and Biophysics·H S LuP H Lai
Jan 1, 1995·Journal of Pharmaceutical and Biomedical Analysis·U HammerlingL Sjödin
Dec 1, 1996·Biologicals : Journal of the International Association of Biological Standardization·A R Mire-SluisR Thorpe
Dec 11, 1999·Nucleic Acids Research·H M BermanP E Bourne

❮ Previous
Next ❯

Citations

Aug 2, 2013·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Pere GascónMatthew Turner
Jun 30, 2012·Nature Reviews. Drug Discovery·Steven A BerkowitzGraham B Jones
May 1, 2012·PharmacoEconomics·Bradford R Hirsch, Gary H Lyman
Feb 22, 2013·Bioanalysis·Meenu Wadhwa, Robin Thorpe
May 13, 2014·Journal of Pharmaceutical and Biomedical Analysis·Eman L ShaltoutMaissa Y Salem
Jul 30, 2014·Journal of the American Society for Mass Spectrometry·Daisuke TsuchidaSatoko Akashi
Feb 10, 2012·Targeted Oncology·Patricia GravelJean-Yves Le Cotonnec
May 29, 2014·Analytical and Bioanalytical Chemistry·Anurag S Rathore, Rahul Bhambure
Nov 28, 2013·Langmuir : the ACS Journal of Surfaces and Colloids·Ivan M KempsonClive A Prestidge
Sep 16, 2011·Expert Review of Anticancer Therapy·Marco DanovaGiovanni L Pappagallo
Nov 21, 2014·Expert Review of Clinical Pharmacology·Margherita Ratti, Gianluca Tomasello
Nov 14, 2012·Biologicals : Journal of the International Association of Biological Standardization·Marcia FedericiDavid B Volkin
May 29, 2012·Journal of Pharmaceutical and Biomedical Analysis·Zsuzsanna Kálmán-SzekeresKatalin Ganzler
Mar 31, 2016·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Anna HausbergerJohann Holzmann
Aug 1, 2014·Bioanalysis·Chris A Singleton
May 23, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Maely P Fávero-RettoLuís Mauricio T R Lima
Jun 22, 2016·Journal of Pharmaceutical and Biomedical Analysis·Maria Kristina ParrHouda Montacir
Jun 13, 2016·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Neh NupurAnurag S Rathore
Oct 4, 2018·Pharmaceutical Research·Liem Andhyk HalimHuub Schellekens
Oct 27, 2018·Current Clinical Pharmacology·Efraín EstebanEdwin Jáuregui

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.