Search results for: Bernhardt L. Trout

Items from 1 to 20 out of 91 results

article

Understanding the Role of Preferential Exclusion of Sugars and Polyols from Native State IgG1 Monoclonal Antibodies and its Effect on Aggregation and Reversible Self-Association

Chaitanya M. Sudrik, Theresa Cloutier, Neil Mody, Hasige A. Sathish, more

Pharmaceutical Research > 2019 > 36 > 8 > 1-12

Purpose To investigate differences in the preferential exclusion of trehalose, sucrose, sorbitol and mannitol from the surface of three IgG1 monoclonal antibodies (mAbs) and understand its effect on the aggregation and reversible self-association of mAbs at high-concentrations. Methods Preferential exclusion was measured using vapor pressure osmometry. Effect of excipient addition on accelerated...

article

Retracted: Molecular characterization of excipients’ preferential interactions with therapeutic monoclonal antibodies

Jehoon Kim, Mark R. H. Krebs, Bernhardt L. Trout

Journal of Pharmacy and Pharmacology > 70 > 2 > 289 - 289

Retraction: Molecular characterization of excipients’ preferential interactions with therapeutic monoclonal antibodies by Jehoon Kim, Mark R. H. Krebs and Bernhardt L. Trout The above article from the Journal of Pharmacy and Pharmacology, first published online on 4 August 2017 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the authors, the journal Editor‐in‐Chief,...

article

Demonstration of pharmaceutical tablet coating process by injection molding technology

Vibha Puri, David Brancazio, Eranda Harinath, Alexander R. Martinez, more

International Journal of Pharmaceutics > 2018 > 535 > 1-2 > 106-112

We demonstrate the coating of tablets using an injection molding (IM) process that has advantage of being solvent free and can provide precision coat features. The selected core tablets comprising 10% w/w griseofulvin were prepared by an integrated hot melt extrusion-injection molding (HME-IM) process. Coating trials were conducted on a vertical injection mold machine. Polyethylene glycol and polyethylene...

article

Tablet coating by injection molding technology – Optimization of coating formulation attributes and coating process parameters

Parind M. Desai, Vibha Puri, David Brancazio, Bhakti S. Halkude, more

European Journal of Pharmaceutics and Biopharmaceutics > 2018 > 122 > C > 25-36

We developed and evaluated a solvent-free injection molding (IM) coating technology that could be suitable for continuous manufacturing via incorporation with IM tableting. Coating formulations (coating polymers and plasticizers) were prepared using hot-melt extrusion and screened via stress-strain analysis employing a universal testing machine. Selected coating formulations were studied for their...

article

Integrated hot-melt extrusion – injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability

Parind M. Desai, Rachael C. Hogan, David Brancazio, Vibha Puri, more

International Journal of Pharmaceutics > 2017 > 531 > 1 > 332-342

This study provides a framework for robust tablet development using an integrated hot-melt extrusion-injection molding (IM) continuous manufacturing platform. Griseofulvin, maltodextrin, xylitol and lactose were employed as drug, carrier, plasticizer and reinforcing agent respectively. A pre-blended drug-excipient mixture was fed from a loss-in-weight feeder to a twin-screw extruder. The extrudate...

article

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Lawrence X. Yu, Ilgaz Akseli, Barbara Allen, Gregory Amidon, more

The AAPS Journal > 2016 > 18 > 2 > 528-543

chapter

Order Parameter Approach to Understanding and Quantifying the Physico-Chemical Behavior of Complex Systems

Ravi Radhakrishnan, Bernhardt L. Trout

Handbook of Materials Modeling > Rate Processes > 1613-1626

Many physico-chemical processes such as nucleation events in phase transitions, chemical reactions, conformational changes of biomolecules, and protein folding are activated processes that involve rare transitions between stable or metastable states in the free energy surface. Understanding the underlying mechanism and computing the rates associated with such processes is a central to many applications.

article

Rational Design of Biobetters with Enhanced Stability

Fabienne Courtois, Curtiss P. Schneider, Neeraj J. Agrawal, Bernhardt L. Trout

Journal of Pharmaceutical Sciences > 104 > 8 > 2433 - 2440

Biotherapeutics are the fastest growing class of pharmaceutical with a rapidly evolving market facing the rise of biosimilar and biobetter products. In contrast to a biosimilar, which is derived from the same gene sequence as the innovator product, a biobetter has enhanced properties, such as enhanced efficacy or reduced immunogenicity. Little work has been carried out so far to increase the intrinsic...

article

End‐to‐End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

Salvatore Mascia, Patrick L. Heider, Haitao Zhang, Richard Lakerveld, more

Angewandte Chemie > 125 > 47 > 12585 - 12589

Eine Serie von Röhren: Ein kontinuierlicher Prozess für die Herstellung eines Medikaments aus chemischen Intermediaten wird beschrieben. Die Anlage im Pilotmaßstab nutzt viele Vorteile von Flussverfahren, um die aktiven pharmazeutischen Inhaltsstoffe und das Medikament in einem integrierten System herzustellen.

article

End‐to‐End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

Salvatore Mascia, Patrick L. Heider, Haitao Zhang, Richard Lakerveld, more

Angewandte Chemie International Edition > 52 > 47 > 12359 - 12363

A series of tubes: The continuous manufacture of a finished drug product starting from chemical intermediates is reported. The continuous pilot‐scale plant used a novel route that incorporated many advantages of continuous‐flow processes to produce active pharmaceutical ingredients and the drug product in one integrated system.

article

Fast and scalable purification of a therapeutic full‐length antibody based on process crystallization

Benjamin Smejkal, Neeraj J. Agrawal, Bernhard Helk, Henk Schulz, more

Biotechnology and Bioengineering > 110 > 9 > 2452 - 2461

The potential of process crystallization for purification of a therapeutic monoclonal IgG1 antibody was studied. The purified antibody was crystallized in non‐agitated micro‐batch experiments for the first time. A direct crystallization from clarified CHO cell culture harvest was inhibited by high salt concentrations. The salt concentration of the harvest was reduced by a simple pretreatment step...

article

Mathematical modeling and design of layer crystallization in a concentric annulus with and without recirculation

Lifang Zhou, Min Su, Brahim Benyahia, Aniruddh Singh, more

AIChE Journal > 59 > 4 > 1308 - 1321

A solution layer crystallization process in a concentric annulus is presented that removes the need for filtration. A dynamic model for layer crystallization with and without a recirculation loop is developed in the form of coupled partial differential equations describing the effects of mass transfer, heat transfer, and crystallization kinetics. The model predicts the variation of the temperature,...

article

Electrospun Formulations Containing Crystalline Active Pharmaceutical Ingredients

Blair Kathryn Brettmann, Kamyu Cheng, Allan S. Myerson, Bernhardt L. Trout

Pharmaceutical Research > 2013 > 30 > 1 > 238-246

Purpose To investigate the use of electrospinning for forming solid dispersions containing crystalline active pharmaceutical ingredients (API) and understand the relevant properties of the resulting materials. Method Free surface electrospinning was used to prepare nanofiber mats of poly(vinyl pyrrolidone) (PVP) and crystalline albendazole (ABZ) or famotidine (FAM) from a suspension of the drug...

article

Quantitative Characterization of Local Protein Solvation To Predict Solvent Effects on Protein Structure

Vincent Vagenende, Bernhardt L. Trout

Biophysical Journal > 2012 > 103 > 6 > 1354-1362

Characterization of solvent preferences of proteins is essential to the understanding of solvent effects on protein structure and stability. Although it is generally believed that solvent preferences at distinct loci of a protein surface may differ, quantitative characterization of local protein solvation has remained elusive. In this study, we show that local solvation preferences can be quantified...

article

Solid‐state nuclear magnetic resonance study of the physical stability of electrospun drug and polymer solid solutions

Blair Kathryn Brettmann, Allan S. Myerson, Bernhardt L. Trout

Journal of Pharmaceutical Sciences > 101 > 6 > 2185 - 2193

A major challenge in utilizing the amorphous form of an active pharmaceutical ingredient (API) in a final oral dosage form is preventing crystallization over time and ensuring stability. One method to improve stability is lowering the mobility of an API by formulating as a solid solution with an excipient. In this work, we use electrospinning to prepare solid solutions of API, aliskiren (SPP) or indomethacin...

article

Production and characterization of carbamazepine nanocrystals by electrospraying for continuous pharmaceutical manufacturing

Mao Wang, Gregory C. Rutledge, Allan S. Myerson, Bernhardt L. Trout

Journal of Pharmaceutical Sciences > 101 > 3 > 1178 - 1188

In this paper, an electrospray technique followed by annealing at high temperatures was developed to produce nanocrystals of carbamazepine (CBZ), a poorly water‐soluble drug, for continuous pharmaceutical manufacturing process. Electrospraying solutions of CBZ in methanol obeys the expected scaling law of current, which is I ∼ Q^1/2 (I, electrical current; Q, flow rate), for liquids with sufficiently...

article

Complex Interactions between Molecular Ions in Solution and Their Effect on Protein Stability

Diwakar Shukla, Curtiss P. Schneider, Bernhardt L. Trout

Journal of the American Chemical Society > 2011 > 133 > 46 > 18713 - 18718

article

Developability index: A rapid in silico tool for the screening of antibody aggregation propensity

Timothy M. Lauer, Neeraj J. Agrawal, Naresh Chennamsetty, Kamal Egodage, more

Journal of Pharmaceutical Sciences > 101 > 1 > 102 - 115

Determining the aggregation propensity of protein‐based biotherapeutics is an important step in the drug development process. Typically, a great deal of data collected over a large period of time is needed to estimate the aggregation propensity of biotherapeutics. Thus, candidates cannot be screened early on for aggregation propensity, but early screening is desirable to help streamline drug development...

article

Aggregation in protein‐based biotherapeutics: Computational studies and tools to identify aggregation‐prone regions

Neeraj J. Agrawal, Sandeep Kumar, Xiaoling Wang, Bernhard Helk, more

Journal of Pharmaceutical Sciences > 100 > 12 > 5081 - 5095

Because of their large, complex, and conformationally heterogeneous structures, biotherapeutics are vulnerable to several physicochemical stresses faced during the various processing steps from production to administration. In particular, formation of protein aggregates is a major concern. The greatest risk with aggregates arises from their potential to give rise to immunogenic reactions. Hence, it...

article

Understanding the Synergistic Effect of Arginine and Glutamic Acid Mixtures on Protein Solubility

Diwakar Shukla, Bernhardt L. Trout

The Journal of Physical Chemistry B > 2011 > 115 > 41 > 11831 - 11839

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INFONA - science communication portal

Search results for: Bernhardt L. Trout

Understanding the Role of Preferential Exclusion of Sugars and Polyols from Native State IgG1 Monoclonal Antibodies and its Effect on Aggregation and Reversible Self-Association

Retracted: Molecular characterization of excipients’ preferential interactions with therapeutic monoclonal antibodies

Demonstration of pharmaceutical tablet coating process by injection molding technology

Tablet coating by injection molding technology – Optimization of coating formulation attributes and coating process parameters

Integrated hot-melt extrusion – injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Order Parameter Approach to Understanding and Quantifying the Physico-Chemical Behavior of Complex Systems

Rational Design of Biobetters with Enhanced Stability

End‐to‐End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

End‐to‐End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

Fast and scalable purification of a therapeutic full‐length antibody based on process crystallization

Mathematical modeling and design of layer crystallization in a concentric annulus with and without recirculation

Electrospun Formulations Containing Crystalline Active Pharmaceutical Ingredients

Quantitative Characterization of Local Protein Solvation To Predict Solvent Effects on Protein Structure

Solid‐state nuclear magnetic resonance study of the physical stability of electrospun drug and polymer solid solutions

Production and characterization of carbamazepine nanocrystals by electrospraying for continuous pharmaceutical manufacturing

Complex Interactions between Molecular Ions in Solution and Their Effect on Protein Stability

Developability index: A rapid in silico tool for the screening of antibody aggregation propensity

Aggregation in protein‐based biotherapeutics: Computational studies and tools to identify aggregation‐prone regions

Understanding the Synergistic Effect of Arginine and Glutamic Acid Mixtures on Protein Solubility

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