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Advanced CMC Analytical Studies and Lab Quality Practices

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Starting 4-day LIVE online training course running on June 20th - 21st & June 23rd - June 24th 1PM - 5PM GMT
Starting 4-day LIVE online training course running on June 20th - 21st & June 23rd - June 24th 1PM - 5PM GMT

LEARN THE TECHNICAL DETAILS OF CRITICAL CMC ANALYTICAL STUDIES REQUIRED THROUGHOUT PRODUCT LIFECYCLES TO DO THEM RIGHT THE FIRST TIME AND REDUCE COSTLY DELAYS

FOR ALL BIOLOGIC THERAPEUTICS, VACCINES, AND ADVANCED MODALITIES

Registration Now Open | Register by 29 April 2022 to Save £400

Interested for your team to Attend? Receive a group discount for registering a group of 3+

Contact Angel Huertas at angel.huertas@informa.com to book your group today

Course Overview

In this advanced course, Dr. Nadine Ritter will take a deep dive into the design and execution of the major analytical CMC studies applicable to different types of biological products, with special notes on biosimilars. Best practices in the validation of methods for relative purity, relative potency, and product stability will be presented. Key details in designing phase-appropriate analytical comparability studies will be discussed, with comparison to unique issues for analytical similarity studies.  Strategies will be presented to overcome typical technical challenges in managing reference standard and critical assay reagents. Finally, emerging analytical expectations for HCPs, SVPs, and E&L data will be discussed.

What will you learn?

Method validation

Learn best practices to address the most difficult validation parameters in critical analytical methods for relative purity, relative potency, and specific impurities and degradants with biological products.

Characterization and comparability

Discuss characterization and comparability studies for a wide variety of biologics including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, plasma products, and complex products (e.g. antibody drug conjugates); review unique challenges in analytical biosimilarity studies

Reference standards

Explore different types and uses of biotechnology reference standards and understand the nature of critical assay reagents.  Discuss important details on lifecycle management of product reference standards and critical assay reagents

HCPs, SVPs, and E&Ls

Understand the background of regulatory concerns for HCPs, SVPs, and E&Ls in biological products, examine the analytical challenges and learn the current and emerging best practices for analytical characterization, comparability, and control of each of these types of process and product impurities.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.

During these sessions students will learn through:

  • Direct interaction with the trainer during live sessions
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

Who is this course for?

This course would be useful for:

  • QC release and stability analysts
  • Stability program managers
  • Product scientists and test method technical experts (R&D and QC)
  • Process analytical chemists and process development scientists
  • Quality assurance specialists
  • GMP compliance auditors
  • Regulatory affairs CMC authors or reviewers
  • Analytical and stability laboratory managers (R&D through GMP)
  • Project managers with CMC responsibilities
  • Business managers with CMC responsibilities
  • Key staff from biotech academic incubators and small start-ups
  • Contract testing labs

The analytical side of CMC with course leader, Nadine Ritter

Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).

Regulatory Affairs

Specialist

Polpharma

It was great that there were real life examples and the trainer conveyed their ability to teach the class well on the topic.

Delegates of our live online academies said...

94%

would attend another live online academy

97%

found the course beneficial to their day to day role

97%

would recommend the course to others