The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Jonathan Angove

Jonathan Angove

Senior Applications Chemist

Ellutia

Ellutia logo

I have over 30 years laboratory experience, both in the UK and USA, primarily in GC, HPLC and ion mobility analyses. During this time, I have acted as a technical lead, specified lab equipment and safety procedures for the detection of toxic industrial chemicals. I have developed methods, including LVI methods of pesticides to various Quality standards, performed internal method auditing, written litigation and customer reports, clinical data packages and technical documents, provided training, customer and sales support, demonstrated methods and equipment, prioritised laboratory work, assisted with new product introduction and the improvement of existing products.

At Ellutia, I have developed the ATNA system (Apparent Total Nitrosamine Analyser) that can be used as a rapid screening tool for the presence of nitrites, nitrates and nitrosamines. Additionally, we are refining the ATNA detector, the TEA (Thermal Energy Analyser), making it 21 CFR Part 11 compliant.

Ellutia logo
Panel

10.30 – 12.00 am CET

Nitrosamine contamination

Is it still an issue today?

Almost six years after N-nitrosodimethylamine (NDMA) contamination was first identified, the toxic short alkyl chain N-nitrosamine issue appears on the way to resolution. In contrast, N-Nitrosamine drug substance-related impurities (NDSRIs) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis. This session will:

  • Review the latest guidelines on nitrosamine risk evaluation and risk assessment
  • Explore analytical techniques for determination of nitrosamine impurities
  • Discuss the path to international regulatory harmonisation.
Varun Ahuja with Syngene logo

Varun Ahuja

Head-Toxicology, Safety Assessment
Syngene International Ltd

Jonathan Angove with Ellutia logo

Jonathan Angove

Senior Applications Chemist
Ellutia

Ivana Gusić with Teva logo

Ivana Gusić

Senior Manager, Nitrosamine Testing and Analytical Technologies
TEVA Pharmaceuticals

Ingrid Hegbom Ekman with Cambrex logo

Ingrid Hegbom Ekman

Director of R&D
Cambrex

Malcolm Ross with Novartis logo

Malcolm Ross

Analytical Specialist - External and Member of Nitrosamine Task Force
Novartis

Archana Bahuguna

Moderator: Archana Bahuguna

Regulatory Compliance SME, Founding Expert Member and Nitrosamine Exchange Ambassador