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The Netherlands Area Biotech Discussion Group - December 2018
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Thursday 6 December 2018 (15:30 - 20:00)

Leiden University, Leiden Academic Center for Drug Research (LACDR)

 
 Thank you to everyone who attended!  
 

 

 Potency Assays


In order to assess the quality of biotechnological products, such as monoclonal antibodies and vaccines, a plethora of analytical methods can be employed. Even though most of these provide information on (a combination) of quality attribute(s), potency assays provide a unique insight into the bioactivity of the molecule, which is probably the most important attribute of them all. This comes at a price though: potency assays, especially cell-based assays, are complicated and thereby challenging to develop and maintain as they intrinsically harbor a series of sources of variation. So, to understand these assays and allow for correct interpretation of the outcome, understanding of the development (and qualification/validation) trajectory, both from an industrial as well as regulatory perspective, is of utmost importance. During the upcoming NLab Biotech Discussion Group meeting on December, 6th, Dr. Sigrid Roosendaal (Consultant, QualityRA) and Dr. Marcel Hoefnagel (Assessor Biopharmaceuticals, CBG-MEB) will share their experience with, and vision on, the development and regulatory aspects of these interesting, but intricate, analytical tools.



Featured Speakers Include:

Marcel Hoefnagel
Medical Evaluations Board (CBG-MEB)

“Regulatory Considerations for Establishing Biological Activity”

 

VIEW ABSTRACT

VIEW SLIDES

Sigrid Roosendaal
Quality RA B.V.

“Potency Assays: Analytical Considerations from a Regulatory Perspective”

 
VIEW ABSTRACT

 VIEW SLIDES

 

Registration for this meeting is now closed.
 
Pre-registration is required; there will be no onsite registration.



Thursday 6 December 2018
15:30 - 20:00

 

Preliminary Schedule:

15:30 - Registration Opens
16:00 - Tour of Facility
17:00 - Program Welcome
17:15 - Lectures
            Networking Break to Follow
 20:00 - Adjourn

 

Location:
Leiden University
Leiden Academic Center for Drug Research (LACDR)

Room EM1.09, in new Gorlaeus Labs building (see below)
Einsteinweg 55
2333 CC Leiden,The Netherlands

 

For more information on upcoming programs, please visit
the Netherlands Area Biotech (NLab) Discussion Group homepage,
here

 

 


 

 

 

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