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Advanced Proteomics Sample Preparation: Targeted Enrichment and Micro-to-Nanogram Scale Workflows
November 15, 8:30am – 5:00pm
Instructor: Reihaneh Safavisohi, Seton Hall University
Course Description:
Analyzing limited samples like clinical biopsies, forensic traces, and low-abundance biomarkers presents a demanding challenge where traditional preparation often fails due to sample loss and background noise. While macroscale techniques effectively recover proteins from milligram quantities, these methods become crippling when only microgram amounts are available. This course provides advanced, practical strategies for proteomics researchers addressing low-input workflows. Participants will explore workflows tailored for micro-to-nanogram scales, emphasizing targeted enrichment and nanoparticle-based approaches. We focus on the bottom-up pipeline, addressing low-input samples, hydrophobic membrane proteins, and post-translational modifications. Attendees will learn to optimize recovery, improve clean-up, and maximize sequence coverage. Click here for more details
Nitrosamine Risk Assessment and Control for Pharmaceutical Products
November 16; 8:30am-5:00pm
Instructor: Jinjian Zheng, Merck & Co., Inc.
Course Description:
This one-day course provides a comprehensive overview of nitrosamine risk assessment and control in pharmaceutical products. We will review key regulatory guidelines (EMA, FDA) and explore nitrosamine formation mechanism and root cause analysis. We will discuss control strategies, including formulation development and analytical testing with a significant focus on analytical method development for trace-level nitrosamines (both common nitrosamines and NDSRIs) and vulnerable amines as well as nitrite in excipients, and practical strategies for implementing routine testing in a QC laboratory environment. This course is ideal for analytical scientists, formulators, and CMC professionals seeking to manage nitrosamine impurities effectively.
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An Overview of Drug Development, Drug Quality, Regulatory, and Quality Control Processes
November 17; 8:30am – 12:00pm (Half-Day)
Instructor: Michael Dong, MWD Consulting
Course Description:
This introductory half-day course overviews the pharmaceutical industry, the new drug development process, and drug quality fundamentals, including concepts, regulations, public standards, and best practices in nonclinical development and manufacturing for quality assurance. You will learn the roles of quality control (QC) and chemistry, manufacturing, and control (CMC) drug development process in ensuring drug products’ safety, efficacy, and quality. It covers industry-standard processes such as SOPs, quality systems, method qualification/validation, release testing, specifications, and certificates of analysis (COA). Specific quality attributes, analytical methodologies for drug substances /products, and regulatory agencies’ roles are described.
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Analytical and Bioanalytical Aspects in ADC Drug Development and Subsequent Regulatory Submission
November 17; 1:00pm – 4:00pm (Half-Day)
Instructors: Xiaohui (Sophia) Xu, Daiichi Sankyo & Zhi Chen, Bristol Myers Squibb
Course Description:
This half-day short course provides an overview of analytical and bioanalytical assays supporting antibody–drug conjugate (ADC) development and regulatory submission readiness. The program reviews key analytical technologies, major challenges, and current perspectives in ADC bioanalysis and CMC development. Emphasis is placed on generating high-quality PK and immunogenicity data to inform PK/PD, safety, and translational decision-making while ensuring data integrity and regulatory compliance. Participants will gain practical insights to support efficient development strategies and smarter decision-making across all stages of ADC development.
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Successfully Implementing Key AQbD Elements in the Current USP and ICH Guidances to Dramatically Accelerate Fit-for-Purpose Analytical Method Development
November 17; 8:30am – 5:00pm
Instructor: Richard Verseput, S-Matrix Corp.
Course Description:
Current USP and ICH guidances affirm the expectation of quantitation and statistical rigor in analytical procedure development. This course describes strategic Analytical Quality by Design (AQbD) tools and methods in these guidances which 1) can be quickly implemented in the lab, 2) generate easily interpretable data and results, and 3) provide the sound, statistically defensible knowledge needed to dramatically accelerate fit-for-purpose method development. Course topics include 1) defining the ATP as a negotiated specification incorporating analytical and production variation, 2) correctly assessing method robustness to establish a Method Operable Design Region (MODR), 3) optimizing the replication strategy to generate reportable results which will consistently meet the ATP-specified performance requirements, and 4) gaining the critical knowledge to transfer to Stages 2 and 3 of the analytical procedure lifecycle. Course topics are presented in the context of LC and LC-MS method development, validation, and transfer. Click here for more details.
Analytical Method Validation and Lifecyle Management – FDA, ICH and USP Expectations
November 15; 8:30am – 5:00pm
Instructor: Kim Huynh-Ba, Pharmalytik Consulting
Course Description:
Analytical laboratories play key roles in the pharmaceutical industry. The generation of data that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; thus, keeping the analytical method in compliance with FDA, ICH and USP regulations is a challenge for analytical scientists. This course will review the current regulations using lifecycle approach to analytical procedures of pharmaceutical products, such as FDA validation guidance, ICH Q2(R2) revision, ICH Q14 concepts, and USP <1220>. Different aspects of validation throughout development phases to establish critical acceptance criteria will also be discussed to establish change control strategies for analytical procedures and application of quality risk management to support continual improvement. Participants are encouraged to discuss their practices on validation of analytical procedures and challenges to maintain compliance. Click here for more details.
Process Analytical Technology: Out of the Lab and into the Line
November 18; 8:30am – 5:00pm
Instructor: James Rydzak, Specere Consulting
Course Description:
Process analytical technology (PAT) is a tool for product development, scale up and manufacturing of any chemical product. In this course, you will learn about the benefits of in-process monitoring, how to justify and plan the analysis implementation. Different process analytical tools will be discussed, how to implement them and how to choose between them for your application. How to use PAT to save time and money, improve your green scores in development and manufacturing become proficient at PAT will be discussed. Various applications, from various industries will be used to explain concepts and provide examples of implementation. Click here for more details.
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