Assessing the Extended In-Use Stability of the Infliximab Biosimilar PF-06438179/GP1111 Following Preparation for Intravenous Infusion

Drugs in R&D
Maja VimpolsekEmmanuel Rossy

Abstract

PF-06438179/GP1111 (PF-SZ-IFX) is an infliximab biosimilar. We evaluated the extended in-use physicochemical and biological stability of PF-SZ-IFX upon preparation for intravenous infusion. Two batches of PF-SZ-IFX were reconstituted to a concentration of 10 mg/mL and subsequently diluted to 0.4 and 4.0 mg/mL, representing the clinically relevant range for intravenous infusion. Dilution was performed in polyethylene saline infusion bags, which are commonly used in clinical practice. To simulate product handling under worst-case conditions, reconstituted solutions were stored for up to 30 days at 5 ± 3 °C and up to 14 days at 25 ± 2 °C (60 ± 5% relative humidity); diluted solutions were stored for up to 30 days under the same sets of conditions. Physicochemical and biological stability were evaluated according to pH, osmolality, appearance, particulate content, protein concentration, proportions of molecular weight variants and charge variants and potency. Standard and state-of-the-art analytical techniques were employed, including imaged isoelectric focusing, size exclusion chromatography, reducing sodium dodecyl sulphate capillary electrophoresis and functional cell-based bioassay. Across batches and concentrations of PF-SZ-IF...Continue Reading

References

Jan 1, 1976·Journal of Immunological Methods·J E Herrmann, M F Collins
Dec 17, 2008·Current Pharmaceutical Biotechnology·J Vlasak, R Ionescu
Mar 10, 2009·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Karl Broich, UNKNOWN Committee for Medicinal Products for Human Use
Jun 6, 2009·Journal of Pharmaceutical Sciences·Yongsheng YangMansoor A Khan
Oct 31, 2009·Biologicals : Journal of the International Association of Biological Standardization·R DobbelaerUNKNOWN World Health Organization
Apr 14, 2011·MAbs·Josef Vlasak, Roxana Ionescu
Aug 8, 2013·Journal of Immunotoxicology·Kirsty D RatanjiIan Kimber
Dec 18, 2014·MAbs·Soon Kwan JungShin Jae Chang
Feb 10, 2016·The International Journal of Pharmacy Practice·Fatma MaraikiMohamed Ahmed
Oct 28, 2016·Advances in Therapy·Mazin DerziMichael W Leach
Sep 28, 2017·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·William C LamannaMartin Schiestl
Nov 24, 2017·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·UNKNOWN Office of Health and Constituent Affairs, U.S. Food and Drug Administration
May 17, 2018·Arthritis·Maria GreenwaldK Lea Sewell

❮ Previous
Next ❯

Methods Mentioned

BETA
electrophoresis
iCE
Size
size exclusion chromatography
deamidation

Software Mentioned

Eur Ph

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.

Related Papers

BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Su Jung KimWon Yong Han
BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Su Jung KimJi Young Kim
Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
William C LamannaMartin Schiestl
© 2022 Meta ULC. All rights reserved