Implementing Transmission Raman for Fast Content Uniformity Testing – from Feasibility Evaluation to a Validated Release Method

Register free: https://www.spectroscopyonline.com/spec_w/transmission_ram

Event Overview:

When considering a new analytical technology in the pharmaceutical industry, two key questions always arise: is there a good business case for it, and what are the regulatory consequences? In this talk, we will present the approach that led to the implementation of transmission Raman spectroscopy for content uniformity testing at a pharmaceutical company. We will show that it is not only the financial benefit, but also the stakeholder enthusiasm that convinced management of the need to invest in new technology for a standard test requirement.

The approach for rolling out transmission Raman spectroscopy to all sites at Grünenthal Pharma involves the development of procedures and templates steered by a Center of Expertise (COE). In the COE the models developed and the standard approach for sample preparation—including required equipment— is determined alongside the validation procedure. The regulatory strategy, including templates, is also determined here. With this approach, Grünenthal Pharma intends to ensure a global standard and enable the ability to support and transfer methods from one site to all others.

Key Learning Objectives:

In this webcast you will learn about:

• The reasons for using transmission Raman spectroscopy for content uniformity and how it works in conjunction with established liquid chromatography (LC) methods.
• The approach that led to the implementation of transmission Raman systems for content uniformity testing at Grünenthal Pharma.
• How roll-out of these new systems relies on a Center of Expertise for model development, sample preparation, validation procedures, and regulatory strategy.
• How the company intends to ensure a global transferable standard in content uniformity testing using transmission Raman spectroscopy

Who Should Attend:

Biopharma and Pharma professionals working in the areas of:

• QA/QC
• Production/Manufacturing
• Operations
• Formulation Development
• R&D

With roles of:

• Lab Manager
• Executive Manager
• QC Manager
• Production Scientist
• Formulation Scientist
• Spectroscopists & Chemometricians

Speakers

Meike Römer, Ph.D.
Manager Process Analytical Technology
Grünenthal Pharma, Germany

Meike has a background in Pharmacy and has a Ph.D from the University of Helsinki, which focused on the physical properties of solid dosage forms during pharmaceutical processing, specializing in multivariate data analysis and spectroscopic methods. She then spent four years at the University of Münster, in the Division of Pharmaceutical Technology, followed by project management roles in Galenical development with Rottendorf Pharma and Corden Pharma. Since 2016 Meike has been a Process Analytical Technology Manager at Grünenthal Pharma, focused on establishing transmission Raman in Quality Control.

Darren Andrews, Ph.D.
Head of Pharma Business, Raman Spectroscopy
Agilent Technologies

Darren has a background in Chemistry and Physical Chemistry with a degree in the former and a Ph.D in the latter, which focused on short pulse laser spectroscopy. He joined Unilever from university, working in the research and product development divisions in Port Sunlight, UK, and in Utsunomiya, Japan. He left there to work in the Science and Technology Facilities Council in IP and business development before spinning off Cobalt Light Systems with the inventor of the technology used in the RapID instrument. Since the company was acquired by Agilent in 2017 Darren has become the Head of Pharma at the new Raman division, based out of Oxford in the UK.

Register free: https://www.spectroscopyonline.com/spec_w/transmission_ram