Peck Symposium 2023 Speakers
Lynne Taylor, Ph.D.
Retter Distinguished Professor of Pharmacy, Industrial & Physical Pharmacy.
Editor-in-Chief of Molecular Pharmaceutics, Purdue University, West Lafayette IN
Talk Title: Recent Advances in Mechanisms Underlying Drug Release from Amorphous Solid Dispersions
Abstract: It is widely accepted that dissolution of crystalline drugs is controlled by diffusional processes. With the increase in poorly soluble drugs, amorphous solid dispersions (ASDs) formulations are becoming more prevalent. Release mechanisms from ASDs are not well understood at a molecular level, are complex, and are highly dependent on drug and polymer chemistries as well as their relative amounts. Recent studies from our group have focused on evaluating the interface between the dissolving solid and the bulk aqueous solution. ASD solids develop an interfacial layer following hydration, that has very different properties from either the dry ASD core, or the aqueous boundary layer, and which controls the release rate of components. Using confocal fluorescence microscopy, in combination with trace amounts of fluorescent dyes which selectively stain hydrophilic and hydrophobic phases, the morphology of this interface can be probed in more detail, and correlated to the release behavior. Furthermore, ternary phase diagrams, describing the equilibrium thermodynamic behavior of the drug-polymer-water mixture, provide insights into the origin of the morphology evolution within the interfacial layer. Together, these studies provide a framework for understand the propensity of drugs with differing physicochemical properties to release from ASDs as a function of drug loading. In turn, this sets expectations about the extent of improvement in release rates that can be achieved for poorly soluble drugs when using an ASD strategy.
R. Christian Moreton, Ph.D,
Partner, FinnBrit Consulting, Waltham, MA, USA
Dr. Moreton has been a partner at FinnBrit Consulting since 2007, providing consulting and advisory services in formulation and process design, development and scale up, and in aspects of excipients. Prior to FinnBrit Consulting, he spent approximately 35 years working mainly as a formulation scientist in large and small innovator companies, and in generic companies in the United Kingdom, Sweden, Canada and the United States. Dr. Moreton has worked on formulation development projects for tablets, hard gel capsules, soft gel capsules, oral liquids, parenteral solutions, creams, ointments, transdermal delivery, pessaries and suppositories. He has also worked in Technical Service, QA, QC and Regulatory Affairs for an excipient and drug delivery company. Dr. Moreton is a visiting tutor at the Manchester University (UK) on their Pharmaceutical Industry Advanced Training (PIAT) distance learning program covering Units on Oral Solid Dosage Forms, and Liquid and Semi-solid Dosage Forms.
Dr. Moreton holds a B.Pharm. (Nottingham University, UK), a M.Sc. in Pharmaceutical Analysis (University of Strathclyde, UK) and a Ph.D. in Pharmaceutics (University of Wales, College of Cardiff; now Cardiff University, UK).
Talk Title: Impact of Advanced Pharmaceutical Manufacturing on Excipients
Stephen Hammond
Stephen Hammond Consulting LLC
Steve retired in 2018 after 39 years with Pfizer Inc. He is now an independent consultant working in the area of analytical sciences related to manufacturing of Pharmaceutical and food products. Steve is an internationally recognized expert in Process based measurements (PAT) and Material Sciences. Steve has extensive experience with advanced manufacturing systems including continuous manufacturing. The last 10 years of Steve’s time at Pfizer had a heavy focus on development of analytical and control systems for continuous manufacturing. Specialist areas include the deployment and use of in-line sensors, spectroscopic systems, chemical imaging, the engineering of sensor interfaces and design of software platforms for in-line measurement integration and functional support. After retirement Steve has continued his interest in developing capabilities in small footprint portable continuous manufacturing, in the areas of Continuous Freeze Drying and Continuous Sterile Liquid production.
Talk Title: PAT in Support of a Quality Risk Management Strategy for Additive Manufacturing System
Yunsong (Frank) Li, Ph.D.
Sr. Director, Product Development, Catalent
Dr. Li is currently the Senior Director of Product Development at Catalent Bioproduct Delivery in Bloomington, Indiana. In his current role, he is responsible for biologics drug product development, including formulation development, drug product process development, analytical development, and forensic sciences. He has been responsible for all the science, development engineering, and technical writing at the site including cell culture development, purification development, analytical development, formulation development, manufacturing sciences, and technology for both drug substances and drug products. His team goals are using advanced technologies, biomanufacturing tools, and other sophisticated services to meet client needs on product development, biologics cGMP manufacturing, sterile product fill finish, device assembling, and packaging. He also serves as an Adjunct Associate Professor in The Department of Industrial & Physical Pharmacy at Purdue University, teaching graduate and pharmacy students about biopharmaceutical development. Before his current role, Frank worked for 7.5 years at Merck & Co. in various roles, including group leader for analytical method development and high throughput testing, group leader for biophysical characterization, and later served as the Associate Principal Scientist in formulation development at Merck in Kenilworth, New Jersey. He was responsible for formulation development and fill-finish process development for Merck biologics including monoclonal antibodies, therapeutic proteins, and antibody-drug conjugates. At Merck, he was also the technical lead on the drug product process compatibility studies and was responsible for process transfer to internal manufacturing sites and CMOs. In a previous role at Merck, he led the analytical team supporting formulation development, and cGMP testing for release and stability studies. He also led efforts on the biophysical characterization for sub-visible particle analysis and protein higher-order structure characterization. Before joining Merck, Frank worked for Amgen as a scientist responsible for late-stage drug product development including formulation, fill-finish process development, and lyophilization scale-up. Frank has a Ph.D. in Pharmaceutical Chemistry from The University of Kansas, Lawrence, Kansas, a M.Sc. in Chemistry from the University of British Columbia, Vancouver, Canada, and a B.Sc. in Chemistry from Peking University, Beijing, China. He has published over 11 peer-reviewed publications.
Talk Title: Leveraging High-Throughput Analytics and Automation to Rapidly Develop High Concentration mAb Formulations
Abstract: Monoclonal antibodies (mAbs) remain some of the most promising biopharmaceuticals for a variety of clinical applications. However, their development is met with technical challenges, as they often require high-concentration formulations. To address those concerns, optimizing formulation components, including high-throughput analytics methods, automation & statistical approach, and excipient design can help reduce the viscosity of highly concentrated mAbs for subcutaneous delivery. In this presentation, The discussion will focus on how to improve the formulation development of high-concentration mAbs to reduce viscosity, and potentially reduce costs and timelines including 1. The benefits of high-throughput analytics method, automation, and statistical approach in the development of high-concentration biologics formulation. 2. A case study for an IgG1 mAb. 3. Proprietary, novel excipients to reduce the viscosity of high-concentration biologics.
Niall Barron, Ph.D.
Professor of Biochemical Engineering, University College Dublin and Principal Investigator, NIBRT
Niall Barron obtained a BA(Mod) in Microbiology from Trinity College Dublin and PhD in Applied Microbiology/Biochemistry from the University of Ulster. He spent three years at Baylor College of Medicine in Houston working on genome engineering strategies to study nuclear steroid receptor function. He returned to Ireland to work on stem cell engineering at Dublin City University. His group subsequently developed a specific focus on the production of recombinant therapeutic proteins using mammalian cells. He was appointed NIBRT Principal Investigator and Professor of Biochemical Engineering in the School of Chemical and Bioprocess Engineering in UCD in 2017.
Talk Title: Modifying RNA Epigenetics to Improve the Production of Recombinant Products
Abstract: Epigenetic modifications to the nucleotides in RNA species has been generating considerable interest in recent years. The role of methylation in particular, including characterising the proteins that add (writers), remove (erasers) and interpret (readers) this epigenetic mark, will be discussed. This talk will consider the potential of targeted methylation as an enhancer of mRNA translation and how this mechanism might be applied to improving Biologics production.
Sandro Matosevic, Ph.D.
Assistant Professor of Industrial & Physical Pharmacy, Purdue University, West Lafayette IN
Dr. Matosevic’s research program focuses on developing new immunotherapies for solid tumors using translational tools to reprogram the therapeutic behavior of natural killer cells and their interaction with the tumor microenvironment by combining approaches in cell therapy, gene engineering, immunology and immunoengineering to (1) Overcome immunometabolic suppression of natural killer cell function in the tumor microenvironment via molecular modulation of their function; (2) Enhance natural killer cell anti-tumor immunity by engineering synthetic genetic constructs that can effectively target solid tumors; (3) Engineer novel cryopreservation platforms devoid of DMSO to improve patient safety upon administration of adoptive natural killer cell therapies.
Theme: Development of Cell Based Immunotherapies
Talk Title: Advances and Opportunities in the Development and Engineering of Cell-based Therapies
Abstract: