Working with USP Methods and the updates to <621>: Allowable Adjustments

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Join us for a dinner and networking event Wednesday June 24, 2026 at the Westwood Tavern in Schaumburg, IL.

Presentation Description:

The biopharmaceutical industry continues to expand rapidly, driving innovation and research with market values now reaching into the billions. Within the commercial world for biopharmaceuticals, one cannot avoid hearing about peptides, oligonucleotides, or monoclonal antibodies and the impact synthetic drugs have had on consumer health. Alongside innovators, generic manufacturers play a critical role by developing bioequivalent biosimilars that reach the market quickly at more affordable prices. To support this need for generics as well as for innovators, the United States Pharmacopeia (USP) has introduced new chapters for synthetic biologics testing and monographs for select peptide analyses to ensure their identity, strength, purity, and performance. As larger and more complex biomolecules become more common, understanding USP–NF monographs and the allowable adjustments under ⟨621⟩ is essential to developing compliant, robust, and accurate chromatographic methods for commercial products. Within this presentation, we will discuss the USP-NF compendial, the recent additions of biologic chapters, working with USP monographs, and discussing <621> for allowable adjustments to liquid chromatography.

Bio:

Robert Moeller obtained his bachelor’s and master’s degrees in chemistry in Analytical and Physical Chemistry at the University of Michigan, Ann Arbor in 2020. His undergraduate and graduate research ranged from developing NLP tools to score and identify cognitive operations and complex reasoning in student chemistry essays, to investigating porous polymer monoliths for solid-state chromatography in small-scale on-chip devices.
For the last five years, Robert has worked within the cGMP regulatory laboratory space across generic pharmaceuticals and CROs in Michigan. His recent employment was with the Food & Drug Administration (USFDA) within their medical products laboratory in Detroit, MI. Within the FDA, he performed analytical testing for the Department of Defense, compliance testing of imported and domestic products for consumer safety, and FDA inspections of drug manufacturing facilities for compliance to 21 CFR Part 210 and 211.
He is now currently employed with Phenomenex as their Biopharmaceutical Business Development Manager for the Midwest. Within his role, Robert is responsible for developing and expanding current and new relationships with scientists and innovators across the biopharmaceutical industry and providing educational materials on complex large biomolecule analysis.
In his free time (if he ever has any), he enjoys making homebrews, ice-skating, playing music, and spending time with his wife, friends, and family, including his new baby niece.

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Rapid LC-MS/MS evaluation of collagen and elastin crosslinks in human and mouse lung tissue

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Join us for a dinner and networking event Wednesday February 25, 2026 at the Westwood Tavern in Schaumburg, IL. The lecture will be presented by Elizabeth Sande. This presentation describes a rapid, efficient method for analyzing post-translational crosslinking in the extracellular matrix, which is crucial for understanding fibrotic diseases such as idiopathic pulmonary fibrosis (IPF). By streamlining LC-MS/MS sample analysis to just two minutes and introducing a tissue-based surrogate matrix for dihydroxylysinonorleucine (DHLNL), the process is less labor-intensive and provides more accurate quantification. Application of this method revealed elevated DHLNL levels in both IPF patient lung tissue and a fibrotic mouse model compared to controls. Importantly, treatment with an anti-fibrotic compound reduced DHLNL levels, indicating the assay’s potential utility for evaluating drug efficacy in fibrosis.

Elizabeth is currently a Scientist II at AbbVie within the High-Throughput, Automation, Bioassay, BioAnalysis (HT-ABBA) group, with a combined decade of hands-on experience in instrumentation and chromatography utilizing LC-MS/MS. She holds a master’s degree in pharmaceutical sciences with a concentration in forensic science from the University of Florida obtained in 2021. Working in a variety of industries such as food, toxicology, and pharmaceuticals has fostered her career and love of separation science.

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CCDG Dinner Lecture: A Method for Emerging Contaminants from Tire Particles in Salmon

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Featured Speaker: Don Shelly

Location: Westwood Tavern Schaumburg, IL

Date: Wednesday November 5, 2025

Time: 6pm – 9pm

Join us before the Dinner Lecture from 6 pm to 6:30 pm for a Happy Half Hour of networking and fun!

This presentation will discuss the development of a novel method for analyzing salmon for the pollutant 6PPD-Quinone. 6PPD-Q was pinpointed in 2020 as the cause of mysterious mass deaths of coho salmon in the Pacific Northwest. Fish exposed to it showed erratic behavior and died before spawning. Although coho salmon are the best-known victims of this poison, other species may also be at risk, and environmental toxicologists are still investigating the broader ecological consequences.  

Don Shelly has over 35 years of experience in the analytical chemistry industry, including over 15 years as a bench chemist in contract laboratories. He’s seen every problem and knows how to fix them. Don is a world-renowned expert in solid-phase extraction and extract cleanup. He has authored publications on QuEChERS cleanup, solid-phase extraction, and reference material usage. Don has years of experience in tracking down and eliminating laboratory contamination.

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CCDG HPLC School 2025

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This course offers a well-designed combination of lecture and hands-on laboratory training. Students gain sufficient theoretical and practical background to perform independent work in liquid chromatography.

The three day course encompasses all major areas of liquid chromatography and related sample preparation techniques likely to be encountered by workers practicing in the field.

Experts active in the field of liquid chromatography lead the course and laboratory sessions.

A full day of intensive laboratory experiments gives the students, working as small teams, invaluable hands-on experience.

The latest high performance UHPLC/HPLC equipment, supplied by leading manufacturers, comprise the chromatographic instrumentation for students to use during the lab sessions. Technical experts from the various companies will guide students through the operation of the system.

Registration Deadline: September 30, 2025

Includes text, supplies, and lunches

Early Registration Discount (August 1 – August 31): $1100

Registration Fee after August 31: $1195

Student Price: $500

Location: Roosevelt University, 1400 N Roosevelt Blvd Schaumburg, IL 60173

Course is October 7- 9, 2025

8 am – 5pm each day

Printed course material is provided, at no extra cost to the student, by the Chicago Chromatography Discussion Group.

Course Instructor:Merlin K. L. Bicking, Ph.D.Woodbury, MN 55125Phone: (651) 731-3670 Fax: (651) 730-0965

Education:

  • Bachelor of Science – Chemistry
  • University of Wisconsin – River Falls, WI
  • Doctor of Philosophy – Organic-Analytical Chemistry
  • Iowa State University – Ames, IA

Dr. Merlin Bicking is the founder of ACCTA, Inc., an analytical chemistry training and consulting firm. With more than 30 years of post-graduate experience in academia, contract research, contract laboratory, and independent consulting, he provides basic through advanced level training on laboratory skills and use of analytical equipment. His expertise includes analytical separations, method development, and problem-solving, using a wide range of techniques including HPLC, GC, GC/MS, SFE, SFC, FTIR, NMR, and absorbance spectrophotometry. Dr. Bicking received a BS in Chemistry from the University of Wisconsin – River Falls and a Ph.D. in Organic-Analytical Chemistry from Iowa State University.

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CCDG Dinner Lecture: Perkin Elmer’s QSight500 LC-MS/MS with StayClean

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Join us for a dinner and networking event Wednesday September 10, 2025 at the Westwood Tavern in Schaumburg, IL. The lecture, presented by Autumn Payne, will cover learnings and insights of the newly released QSight500 UHPLC-triple quadrupole system, focusing on StayCleanTM technology that allows for increased robustness, better ion transmission, less contamination buildup and less required maintenance. StayCleanTM Ion Source is designed to handle increased matrix components while overcoming contamination buildup and avoiding subsequent interferences. The instrument performance will be highlighted by a variety of studies testing for robustness, and applications that Perkin Elmer has successfully implemented, including pesticide/herbicide/fungicide analysis and PFAS analysis in a variety of dirty matrices.

Bio:

Autumn Payne is a Field Application Scientist currently working at Perkin Elmer, specializing in LC and LC-MS/MS applications. She has been with the company for three years and is based out of Kalamazoo Michigan. Her previous experiences were as a lab manager and analyst in environmental testing laboratories. She operated a variety of instruments (ICP-OES, ICP-MS, GFAA, HPLC-UV, UHPLC-MS/MS, GC-FTIR, GC-MS) for the analysis of plants, drinking water and wastewater samples. She has a passion for delivering clean and safe products that are quality tested for potential contaminants of concern. She also values providing support for laboratories through the learning process with new instruments. In her free time, she enjoys adventuring outdoors and spending quality time with loved ones and her two handsome cats.

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Save the Date! 2025 CCDG: AN INTRODUCTORY COURSE IN LIQUID CHROMATOGRAPHY

Registration Details Coming Soon !

October 7 – 9, 2025

8:30 AM  4:00 PM

 Roosevelt University, Schaumburg Campus

1400 N Roosevelt Boulevard Schaumburg, IL 60173

Instructor: Merlin K. L. Bicking, PhD

Description

This course provides comprehensive theoretical and practical instruction to enable independent work in liquid chromatography. 2 days in the classroom are followed by a day in the laboratory where students, guided by representatives by all leading LC vendors, put into practice what they’ve learned.

Early Registration Discount

$ 1100 August 1 – August 31

$1195 after August 31

Students $500.00

Registration Details Coming Soon !

For questions, contact rich_demuro@waters.com

CCDG Dinner Lecture: Solid-Phase Extraction: All C18s Are Not the Same

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Join us for a dinner and networking event Wednesday April 16, 2025 at the Westwood Tavern in Schaumburg, IL. The lecture, presented by Don Shelly, will cover learnings and insights on how all C18s are not created equal in solid-phase extraction. This presentation will present blind performance data from multiple sorbent manufacturers’ C18s and how their C18s compare under duplicate extraction conditions. Other helpful information will be included.

CCDG Dinner Lecture: Streamlining the Complexities of Method Development

Join us for a dinner and networking event Thursday March 13, 2025 at the Westwood Tavern in Schaumburg, IL. The lecture, presented by Nivesh Mittal, will cover learnings and insights on a cutting-edge platform designed to streamline the complexities of method development.

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Driven by the recent revisions in ICH Q2(R2) and the introduction of Q14, the adoption of Analytical Quality by Design (AQbD) principles has become increasingly critical for analytical method development . This risk-based approach emphasizes a thorough understanding of analytical methods through systematic experimentation, including Design of Experiments (DoE) and the establishment of a design space to elucidate the impact of method parameters on analytical results. This paradigm shift facilitates the development of robust and reliable methods with minimized risk, independent of an analyst’s experience.

LabSolutions MD is a cutting-edge AQbD-driven platform designed to streamline the complexities of method development. By simplifying the critical phases of method development—screening, optimization, and robustness testing—LabSolutions MD empowers users to navigate the challenges of traditional method development with ease. This presentation will delve into the limitations of manual method development and showcase how LabSolutions MD provides innovative tools to overcome these obstacles. Furthermore, real-world case studies from the pharmaceutical and biopharmaceutical sectors will be presented, highlighting the successful implementation of LabSolutions MD in diverse analytical workflows.