Formulation & Translation Core
Major Core Instrument / Services
LC/MS Sample Analysis
Waters H-Class UPLC with UV Fluorescence and QDA Mass Detection
Drug formulation, concentration, and stability analysis
Analysis of peptides, proteins, and RNA
Intuitive operation, effortless integration, and resolving complexity
Thermo TSQ Altis Plus Triple Quad Mass Spectrometer
Biomarker analysis in plasma and tissues
Pharmacokinetics of complex molecules
Biomacromolecule characterization
LNPs Formulation
Lipid Nanoparticle Formulation
The Core established lipid nanoparticle (LNP) formulation and analytical characterization methodologies for RNA delivery. Several collaborations using these technologies including:
delivery of CRISPR-CAS contracts to select cancer mutations
delivery of siRNA
delivery of STING agonists
brain-targeting antibodies for decorating LNP for penetration of the brain-blood barrier
The LNP manufacturing is among the most widely used expertise of the core lipid nanoparticle (LNP) formulation and analytical characterization methodologies for RNA delivery.
We are also excited to welcome a new upgraded micro-fluidic device, the NanoGenerator Flex-S Nanoparticle Synthesis System from Precigenome, designed for LNP, liposome, and PLGA synthesis, which will aid in scientific research, screening, and discovery with quick low-volume preparation ranging from 0.1 to 2mL per run.
Consultation Services
The Core offers:
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support on sample analysis and experiment design.
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support on market assessment and FDA regulation
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facilitate interactions for intellectual property (IP) protection and support the submission of translational grant applications within the University of Michigan (UM) and government agencies.
These efforts will not only enable the filing and prosecution of patents but also ensure a comprehensive due diligence process for potential out-licensing opportunities.
Rates & Contacts
For University of Michigan Users:
• LC/MS Sample Analysis …….. $65/hr
• LNPs Formulation ………………… $135/hr
• Consulting ……………………………….. $89/hr
For Academic & Non-Profit Users:
• LC/MS Sample Analysis …….. $84/hr
• LNPs Formulation ………………….$174/hr
• Consulting ……………………………….. $115/hr
For Industry Users:
• LC/MS Sample Analysis …….. $94/hr
• LNPs Formulation ………………… $196/hr
• Consulting ……………………………….. $129/hr
To ask for a quote, email: BIBC-TechnologyCore@umich.edu
For LC/MS inquires, email: Dr. Brain Shay, bjshay@umich.edu
For LNPs inquires, email: Dr. Lei Mei, leimei@med.umich.edu
Our Formulation & Translation Core Researchers
Karl oversees laboratory safety operations and helps managing the Formulation and Translation Core.
Anna Schwendeman
William I. Higuchi Collegiate Professor of Pharmacy and Professor of Pharmaceutical Sciences,Director of Formulation and Translation Core Contact Information:annaschw@umich.edu
Schwendeman’s principal research interest is to understand how phospholipid composition of high-density lipoprotein (HDL) affects its potency and to design short synthetic peptides that mimic various functions of Apolipoprotein A-I, the main HDL protein. Laboratory work focuses on HDL for treatment of sepsis, Alzheimer’s disease, complications of diabetes, lupus and other autoimmune diseases and using synthetic HDL nanoparticles for targeted drug delivery purposes and designing artificial HDL based on gold nanoparticles.
Steven Schwendeman
Program Director. Chair and Ara G. Paul Professor of Pharmaceutical Sciences Contact Information:schwende@umich.eduThe Schwendeman lab focuses on understanding the physical chemistry and engineering of PLGA and related delivery systems, aqueous microencapsulation of large molecules in biodegradable polymers, stability of peptides and proteins, vaccine delivery, tissue engineering, and local/regional drug delivery to the eye, brain, head and neck, and diabetic wounds.
Lei Mei
Research Investigator in Dr. Anna Schwendeman’s lab Contact Information:leimei@med.umich.eduDr. Lei Mei graduated in Chemistry from Hunan University in China and earned her PhD in Food Science from the University of Maryland, College Park, US. Her research focuses on formulation of lipid nanoparticle-based delivery systems for biological disorder disease treatment and cancer therapy. She is an expert in nanostructure analysis, specifically focused on safety, efficacy, and stability evaluation of lipid nanoparticles through physical and chemical analysis. She is currently a Research Investigator in the department of Pharmaceutical Science at the University of Michigan within Dr. Anna Schwendeman’s lab.
Brian Shay
Research Lab Specialist Lead in Dr. Anna Schwendeman’s lab Contact Information:bjshay@umich.eduDr. Shay is a seasoned analytical chemist with a specialty in mass spectrometry and chemical analysis, with experience spanning academia and industry. Starting with a Ph.D. from Purdue University, he has held roles at the University of Michigan, Wayne State University, Waters Corporation, and Unilever Research U.S. Most recently, he joined the University of Michigan’s College of Pharmacy in 2022, overseeing research in drug formulations. Previously, he managed a mass spectrometry facility and contributed to analytical chemistry research in various capacities. Dr. Shay’s career has been marked by his expertise in instrument maintenance, method development, and training researchers in advanced analytical techniques.