Introduction:

Ensuring the potency of biopharmaceutical products within a Good Manufacturing Practice (GMP) environment is critical for regulatory compliance and patient safety. This seminar will offer real-world case studies and insights which highlight effective strategies for conducting potency assays in a Quality Control (QC) setting. Attendees will gain practical knowledge and valuable insights into the challenges, best practices, and regulatory considerations of performing potency assays within a GMP QC environment

Topics :

1. Approaches for Faster and More Efficient GMP Potency Assay Transfers by Alexander Knorre

2. Validation and bridging of a flow cytometry-based potency assay (Case Study) by Frances Reichert

3. Bioassay Nuts and Bolts:  Development of Reliable and Robust Assays for Potency Determination by Frances Reichert

4. Breaking Ground: Innovations and Insights in Bioassay Development from scratch (Case Study) by Giulia Mancini

5. Bioassay Potency Analysis – Basics and Current Challenges by Ralf Stegmann

6. Beyond Theory: Case Studies Demonstrating SPR and BLI Applications for Determination of Affinity, Kinetics and Potency by Alexander Knorre

7. Accelerating biologics development programs with phase-appropriate ready-to-use potency bioassays by Gaurav Agrawal

8. From Manual to Automated: Optimizing Bioassays for Precision and Throughput by Frances Reichert

 
Trainers:

Alexander Knorre

Dr. Alexander Knorre is Head of Quality Control at Eurofins BioPharma Product Testing Munich GmbH and has more than 20 years of experience in the Biotech/Pharmaceutical industry. He is Senior Scientific Director Biologics and Bioassay for the European part of the global Eurofins BioPharma Product Testing network. Currently, he oversees four biologics groups in Munich providing QC GMP services and assay development services for bioassays, impurity assays, protein analytical assays and ATMP assays to a global client base.

He received his Ph.D. in Cell and Molecular Biology at the University of Freiburg (Germany) in 2001 and joined Eurofins as bioassay expert in 2003 after 2 years as post doc at the Gene Center of the University of Munich (LMU).

 

Frances Reichert

Dr. Frances Reichert has been employed at Eurofins BPT Munich (DACH) since 2010 and is currently a Technical Specialist for Biologics within the sales department, filling the gap between technical requirements and customer needs. Frances has accumulated more than 10 years of experience in the development and validation of cell-based potency assays and binding ELISAs.

Prior to this role, she served as Head of the Bioassay Development and Validation Department at Eurofins BPT Munich. Since 2010, she has held a position as quality control manager for QC bioassays, The tasks were to develop, qualify, validate, and transfer various potency assays.

Frances studied Biotechnology and holds a PhD degree from the University of Frankfurt.

 

Ralf Stegmann

Ralf Stegmann entered the field of biological assay analysis as a software developer in 1998. He received a PhD in Computational Chemistry from the University of Marburg. Ralf is the founder and CEO of Stegmann Systems, a software company with 50 employees. His company develops PLA 3.0, the software for biostatistical analysis which is currently used by over 800 companies and regulators. Ralf has also been serving as a member of the U.S. Pharmacopeia Bioassay Expert panel since 2017.

 

Giulia Mancini

Giulia Mancini, PhD is the Lab Manager of the bioassay testing team, under biologics business unit, in Eurofins BPT in Milan, Italy. After her master’s degree in medical biotechnology and molecular Medicine, she holds PhD in Biochemical Science. During her academic career, she received different oral communication prizes, as well as numerous awards for her research.

She has experience in scientific research and laboratory operations, and she is dedicated to driving excellence and innovation in every aspect of laboratory management. With a solid background in Biopharma testing, she oversees the planning, execution, and optimization of laboratory processes to ensure the highest standards of quality and efficiency.

She is also adept at fostering a collaborative and supportive work environment, leading, and mentoring diverse teams of scientists and technicians, empowering them to achieve their full potential and fostering a culture of continuous learning and professional development.

Driven by a passion for scientific discovery and a commitment to excellence, she is dedicated to leveraging her skills and experience to actively contribute & support Biopharma product Testing.

 

Gaurav Agrawal

Gaurav Agrawal completed his Ph.D. in Cell and Molecular Biology at the Indian Institute of Science, where his research focused on investigating the activation mechanism of GPCRs. He then pursued postdoctoral research at the University of California San Diego, where he uncovered a novel intracellular trafficking pathway, which is vital for organelle biogenesis. His research work has been published in high-impact peer-reviewed journals. At Eurofins DiscoverX, Gaurav leads the Market Development team as the Global Director of Scientific Applications and plays a leading role in driving industry adoption of DiscoverX's cell-based assay portfolio. He and his team also support global assay transfers to CRO/CDMOs for drug development programs focusing on biologics and biosimilars.

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Applicable fee – € 250  Excl VAT* 

FEE INCLUDES: DOCUMENTATION, LUNCH AND REFRESHMENT.
You’ll receive confirmation, payment and invoicing details via e-mail after submission.

* PAYMENT AND BANK DETAILS:

Eurofins Pharmaceutical Product Testing Belgium NV
Venecoweg 5
9810 Nazareth
Belgium
TAV: BE0435237515

GENERAL TERMS AND CONDITIONS:
IF YOU CANNOT ATTEND THE WORKSHOP YOU HAVE TWO OPTIONS:
1. WE ARE HAPPY TO WELCOME A SUBSTITUTE COLLEAGUE AT ANY TIME.
2. IF YOU HAVE TO CANCEL ENTIRELY WE MUST CHARGE THE FOLLOWING PROCESSING FEES:
- UNTIL 1 WEEK PRIOR TO THE WORKSHOP 50% OF THE REGISTRATION FEE WILL BE CHARGED;
- LESS THAN 1 WEEK PRIOR TO THE WORKSHOP FULL REGISTRATION FEE WILL BE CHARGED.

EUROFINS BIOPHARMA PRODUCT TESTING RESERVES THE RIGHT TO CANCEL OR ALTER THE PROGRAMME, THE SPEAKERS, THE DATE OR VENUE. IF THE EVENT MUST BE CANCELLED, REGISTRANTS WILL BE NOTIFIED AS SOON AS POSSIBLE AND WILL RECEIVE A FULL REFUND OF FEES PAID. EUROFINS BIOPHARMA PRODUCT TESTING IS NOT RESPONSIBLE FOR AIRFARE, HOTEL OR OTHER COSTS INCURRED BY REGISTERED DELEGATES.

TERMS OF PAYMENT:
IMPORTANT: THIS IS A BINDING REGISTRATION AND ABOVE FEES ARE DUE IN CASE OF CANCELLATION OR NON-APPEARANCE. IF YOU CANNOT TAKE PART, YOU HAVE TO INFORM US IN WRITING. THE CANCELLATION FEE WILL THEN BE CALCULATED ACCORDING TO THE POINT OF TIME AT WHICH WE RECEIVE YOUR MESSAGE. ONLY AFTER WE HAVE RECEIVED YOUR PAYMENT, YOU ARE ENTITLED TO ATTEND THE WORKSHOP.