Spray drying of monoclonal antibodies: investigating powder-based biologic drug substance bulk storage

M Bowen, R Turok, YF Maa - Drying technology, 2013 - Taylor & Francis
Biologic drug substances (DSs) are stored and transported as frozen bulk in various
containers, each having disadvantages. We evaluated a powder-based bulk storage approach …

Translational approaches for brain delivery of biologics via cerebrospinal fluid

SS Sadekar, M Bowen, H Cai… - Clinical …, 2022 - Wiley Online Library
Delivery of biologics via cerebrospinal fluid (CSF) has demonstrated potential to access the
tissues of the central nervous system (CNS) by circumventing the blood‐brain barrier and …

[PDF][PDF] Manufacturing of high-concentration monoclonal antibody formulations via spray drying-the road to manufacturing scale

B Gikanga, R Turok, A Hui, M Bowen… - PDA J Pharm Sci …, 2015 - researchgate.net
Spray-dried monoclonal antibody (mAb) powders may offer applications more versatile than
the freezedried cake, including preparing high-concentration formulations for subcutaneous …

Investigating high-concentration monoclonal antibody powder suspension in nonaqueous suspension vehicles for subcutaneous injection

M Bowen, N Armstrong, Y Maa - Journal of pharmaceutical sciences, 2012 - Elsevier
Developing high-concentration monoclonal antibody (mAb) liquid formulations for subcutaneous
(sc) administration is challenging because increased viscosity makes injection difficult. …

[HTML][HTML] Investigation of Human Intrathecal Solute Transport Dynamics Using a Novel in vitro Cerebrospinal Fluid System Analog

A Seiner, GKR Burla, D Shrestha, M Bowen… - Frontiers in …, 2022 - frontiersin.org
Background: Understanding the relationship between cerebrospinal fluid (CSF) dynamics
and intrathecal drug delivery (ITDD) injection parameters is essential to improve treatment of …

Evaluating the Effect of Injection Protocols on Intrathecal Solute Dispersion in Non-Human Primates: An In Vitro Study Using a Cynomolgus Cerebrospinal Fluid …

GKR Burla, D Shresth, M Bowen, J Horvath, BA Martin - 2023 - researchsquare.com
Background: Achieving effective drug delivery to the central nervous system (CNS) remains
a challenge for treating neurological disorders. Intrathecal (IT) delivery, which involves direct …

Effect of external surface terminal sterilization of prefilled syringes (PFS) with ethylene oxide (EO) on the concentration and stability of ranibizumab (RBZ)

…, S Ranade, I Stoilov, J Lin, M Bowen - … & Visual Science, 2019 - iovs.arvojournals.org
Purpose: The RBZ 0.3 mg PFS eliminates the need for drug transfer from vial to syringe.
External surface sterilization of the PFS for intravitreal use requires the removal of potential …

Novel Applications of Advanced Bioimaging: Quantification of Intrathecal Solute Transport to the Brain and Magnetic Resonance Imaging of Ophthalmic Structural …

AJ Seiner - 2021 - search.proquest.com
The field of bioimaging science has been continually evolving over the recent years. Typically,
bioimaging is used to noninvasively visualize biological processes in real time at multiple …

Stability of IgG1 monoclonal antibodies in intravenous infusion bags under clinical in-use conditions

A Sreedhara, ZK Glover, N Piros, N Xiao, A Patel… - Journal of …, 2012 - Elsevier
Compounding pharmacists are expected to prepare safe and efficacious doses of medication
under time and economical constraints while protecting pharmacy staff and caregivers …

Fusobacterium nucleatum metabolically integrates commensals and pathogens in oral biofilms

…, M Kuboniwa, S Shimma, SA Alghamdi, S Mayumi… - Msystems, 2022 - Am Soc Microbiol
Fusobacterium nucleatum is a common constituent of the oral microbiota in both periodontal
health and disease. Previously, we discovered ornithine cross-feeding between F. …