Short Course: Characterization of Biopharmaceuticals

The course will be held on Thursday, 24 October 2024. Your course registration includes this full-day course which is scheduled from 9:30 - 17:30 CET, lunch, as well as any supplemental presentation materials that will be provided during the session. 

Registration Fees

Location

DoubleTree by Hilton Rotterdam Centre (formerly MaasHotel Rotterdam Centre and Mainport Hotel Rotterdam)
Leuvehaven 80
Rotterdam, Zuid-Holland 3011 EA, Netherlands
Telephone: +31 413 4139

Instructors
Pepijn Burgers, Johnson & Johnson Innovative Medicine
Eef Dirksen, Byondis B.V.
Karin Hoogendoorn, Galapagos NV

This Netherlands Area Biotech (NLab) Discussion Group short course addresses the different aspects that are relevant for the extended characterization of biopharmaceutical products according to regulatory guidelines and expectations. It is intended for both junior and experienced analytical and regulatory staff that work in the field of CMC development of biopharmaceuticals, from either an industry, academic, or regulatory point of view.

Different critical quality attributes (CQA) categories, e.g., potency, product related impurities and process related impurities, should be monitored extensively as these impact quality, safety and/or efficacy of biopharmaceuticals such as monoclonal antibody-based products, (viral) vectors, and cell therapy products. Analytical characterization data is used to understand the various CQA categories throughout the lifecycle of the product as part of process and product characterization. This data can further support comparability studies, investigations, reference material qualifications, et cetera.

In this course, we aim to provide insight into analytical characterization and show how analytical characterization data can be acquired systematically to eventually find its way into the various sections of Module 3 of regulatory submission filings. The course will cover the following:

1. Defining a characterization strategy
2. The advanced analytical technologies available for characterization
3. How characterization can support determination of critical quality attributes
4. Different purposes of product characterization, e.g., comparability and reference material qualifications
5. Current regulatory guidelines
6. Interactions with regulatory authorities (scientific advice, clinical trial application, commercial license application, e.g., BLA)
7. Expectations at different phases of clinical development and commercial stage

We will provide a solid theoretical background on the analytical methods that are typically used to thoroughly characterize complex biotherapeutic molecules, not only biochemically, but also biophysically and biologically. In addition, an overview will be presented on the structure of Module 3 and what sections typically contain analytical characterization data to demonstrate sufficient knowledge on, e.g. the molecular structure, the most common degradation pathways of the biotherapeutic and how these impact the functionality of the product. Moreover, the course will feature case studies that focus on specific applications of characterization strategies to gain insight into the molecular heterogeneity of biotherapeutic products.

The course is intended for both junior and experienced analytical and regulatory staff that work in the field of CMC development of biopharmaceuticals, from either an industry, academic, or regulatory point of view. It is also valuable for people working in adjacent fields such as research, quality control/assurance, or process development.