Search Results - "Carpenter, John F."

Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics by Verhoef, Johan J.F., Carpenter, John F., Anchordoquy, Thomas J., Schellekens, Huub

“…•PEGylated nanocarriers are linked to the accelerated blood clearance (ABC) phenomenon.•The ABC is induced by anti-PEG antibodies and/or complement…”
Get full text

Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces by Mehta, Shyam B, Carpenter, John F, Randolph, Theodore W

“…In this study, we investigated the effect of ionic strength (1.25-231 mM) on viscoelastic interfacial gels formed by a monoclonal antibody at silicone…”
Get more information

Impact of Ethylene Oxide Sterilization of Polymer-Based Prefilled Syringes on Chemical Degradation of a Model Therapeutic Protein During Storage by Funatsu, Kaori, Kiminami, Hideaki, Abe, Yoshihiko, Carpenter, John F

“…Materials from prefilled syringe systems-such as silicone oil, tungsten, glass, and rubber-may enhance therapeutic protein aggregation and particle formation…”
Get more information

Gelation of a monoclonal antibody at the silicone oil-water interface and subsequent rupture of the interfacial gel results in aggregation and particle formation by Mehta, Shyam B, Lewus, Rachael, Bee, Jared S, Randolph, Theodore W, Carpenter, John F

“…The formation of viscoelastic gels by a monoclonal antibody (mAb) at the silicone oil-water interface was studied using interfacial shear rheology. At a…”
Get more information

Microparticles and Nanoparticles Delivered in Intravenous Saline and in an Intravenous Solution of a Therapeutic Antibody Product by Pardeshi, Neha N, Qi, Wei, Dahl, Kevin, Caplan, Liron, Carpenter, John F

“…Intravenous (IV) infusion is used for administration of a large proportion of biologic therapeutics, including most monoclonal antibody products. In this…”
Get more information

Immunogenicity of aggregates of recombinant human growth hormone in mouse models by Fradkin, Amber Haynes, Carpenter, John F, Randolph, Theodore W

“…Aggregation of recombinant therapeutic protein products is a concern due to their potential to induce immune responses. We examined the immunogenicity of…”
Get more information

Effects of Product Handling Parameters on Particle Levels in a Commercial Factor VIII Product: Impacts and Mitigation by Ueda, Tsutomu, Nakamura, Koji, Abe, Yoshihiko, Carpenter, John F

“…To reduce the risk of immunogenicity that may be caused by therapeutic protein products, it is important to properly characterize subvisible particles and to…”
Get more information

Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution by Thirumangalathu, Renuka, Krishnan, Sampathkumar, Ricci, Margaret Speed, Brems, David N, Randolph, Theodore W, Carpenter, John F

“…Silicone oil, which is used as a lubricant or coating in devices such as syringes, needles and pharmaceutical containers, has been implicated in aggregation…”
Get more information

Silicone oil microdroplets and protein aggregates in repackaged bevacizumab and ranibizumab: effects of long-term storage and product mishandling by Liu, Lu, Ammar, David A, Ross, Lindsey A, Mandava, Naresh, Kahook, Malik Y, Carpenter, John F

“…To quantify levels of subvisible particles and protein aggregates in repackaged bevacizumab obtained from compounding pharmacies, as well as in samples of…”
Get full text

Analytical approaches to assess the degradation of therapeutic proteins by Filipe, Vasco, Hawe, Andrea, Carpenter, John F., Jiskoot, Wim

“…•Main analytical techniques for degraded protein products are presented.•Current analytical challenges are addressed.•Analytical strategies during product…”
Get full text

Some Lessons Learned From a Comparison Between Sedimentation Velocity Analytical Ultracentrifugation and Size Exclusion Chromatography to Characterize and Quantify Protein Aggregates by Gandhi, Aditya V, Pothecary, Mark R, Bain, David L, Carpenter, John F

“…There are numerous problems with size exclusion chromatography (SEC), which often lead to inaccuracies in protein aggregate characterization. Hence, this study…”
Get more information

The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study by Liu, Lu, Qi, Wei, Schwartz, Daniel K, Randolph, Theodore W, Carpenter, John F

“…We investigated the effects of excipients in solutions of keratinocyte growth factor 2 (KGF-2) on protein aggregation during agitation as well as on…”
Get more information

Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products by Carpenter, John F, Randolph, Theodore W, Jiskoot, Wim, Crommelin, Daan J A, Middaugh, C Russell, Winter, Gerhard

Get more information

Effects of surfaces and leachables on the stability of biopharmaceuticals by Bee, Jared S, Randolph, Theodore W, Carpenter, John F, Bishop, Steven M, Dimitrova, Mariana N

“…Therapeutic proteins are exposed to various potential contact surfaces, particles, and leachables during manufacturing, shipping, storage, and delivery. In…”
Get more information

In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations by Chisholm, Carly Fleagle, Nguyen, Bao Han, Soucie, Kaitlin R, Torres, Raul M, Carpenter, John F, Randolph, Theodore W

“…Subvisible particles in a therapeutic protein product may act as adjuvants to promote unwanted immune responses against the protein. Silicone oil is used as a…”
Get more information

Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing by Kueltzo, Lisa A, Wang, Wei, Randolph, Theodore W, Carpenter, John F

“…Freeze-thawing is a potentially damaging stress to which therapeutic proteins can be exposed deliberately during storage of bulk drug substance, and…”
Get more information

Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice by Freitag, Angelika J., Shomali, Maliheh, Michalakis, Stylianos, Biel, Martin, Siedler, Michael, Kaymakcalan, Zehra, Carpenter, John F., Randolph, Theodore W., Winter, Gerhard, Engert, Julia

“…Purpose The potential contribution of protein aggregates to the unwanted immunogenicity of protein pharmaceuticals is a major concern. In the present study a…”
Get full text

Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes by Gerhardt, Alana, Nguyen, Bao H, Lewus, Rachael, Carpenter, John F, Randolph, Theodore W

“…Silicone oil is used as a lubricant in glass pre-filled syringes (PFS) but can contribute to the generation of particles within protein formulations in PFS. To…”
Get more information

Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation by Chi, Eva Y, Krishnan, Sampathkumar, Randolph, Theodore W, Carpenter, John F

“…Irreversible protein aggregation is problematic in the biotechnology industry, where aggregation is encountered throughout the lifetime of a therapeutic…”
Get full text

IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers by Basu, Pinaki, Krishnan, Sampathkumar, Thirumangalathu, Renuka, Randolph, Theodore W, Carpenter, John F

“…Understanding and mitigating particle formation in prefilled syringes are critical for ensuring stability of therapeutic proteins. In the current study,…”
Get more information